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Recalls affecting Alaska

Data last updated: September 9, 2026 at 1:18 PM UTC

16,261 recalls found
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Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

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UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98793
Lot/product code:
REF(Material)/UDI-DI/Lot(Batch): CDC-25142-X1A/30801902123597, 10801902193275/36F25E0021, 33F25B0467
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION KIT/AK-05502D; EPIDURAL CATHETERIZATION KIT/AK-05503; EPIDURAL CATHETERIZATION KIT/AK-05503-L; SPINAL ANES/EPIDURAL CATH KIT/AK-05560; SPINAL ANES/EPIDURAL CATH KIT/ASK-02520-SBMC1; EPIDURAL CATHETERIZATION KIT/ASK-05400-BW1; EPIDURAL CATHETERIZATION KIT/ASK-05400-GH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05401-LMC; EPIDURAL CATHETERIZATION KIT/ASK-05401-NM; SPINAL ANES/EPIDURAL CATH KIT/ASK-05500-BID1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-JHH1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-MCV1; EPIDURAL CATHETER KIT: 19GA X 90CM ASK-05500-MVH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-UMC; 19 GA X 35.5 IN EPIDURAL CATHETER KIT/ASK-05502-MLH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-JMH1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-MKD2; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-OM1; EPIDURAL CATHETERIZATION KIT/ASK-17019-SM; EPIDURAL CATHETERIZATION KIT/BP-05501; EPIDURAL CATHETERIZATION KIT/CK-05401; EPIDURAL CATHETERIZATION KIT/HS-05501; EPIDURAL CATHETERIZATION KIT/MM-05501; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TK; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKD; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKL; EPIDURAL CATHETERIZATION KIT/MSO-05401-JMH; EPIDURAL CATHETERIZATION KIT/NM-05401; EPIDURAL CATHETERIZATION KIT/SJ-05501; EPIDURAL CATHETERIZATION KIT/SM-05401; EPIDURAL CATHETER KIT: 19 GA X 90 CM/TM-05401; EPIDURAL CATHETERIZATION KIT/TM-05502; SPINAL ANES/EPIDURAL CATH KIT/UI-05502; SPINAL ANES/EPIDURAL CATH KIT: 19 GA/ASK-05400-SHM; EPIDURAL CATH KIT: 19 GA/ASK-05400-UOM; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-MR; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-TM; EPIDURAL CATHETERIZATION KIT/ASK-05501-BHL1; EPIDURAL CATHETERIZATION KIT/ASK-05501-GH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-SM; EPIDURAL CATHETERIZATION KIT/ASK-05502-BSM; EPIDURAL CATHETERIZATION KIT/ASK-05502-MGH1; EPIDURAL CATHETERIZATION KIT/ASK-05503-BWB1; EPIDURAL CATHETERIZATION KIT/ASK-05503-HMH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-SPH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-UPM1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-UCI2; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-17019-UMP; EPIDURAL CATHETERIZATION KIT/MH-05503-1; EPIDURAL CATHETERIZATION KIT/ASK-05401-VB2; Epidural Catheterization Kit: 19GA/ASK-05500-SC1; Epidural Catheterization Kit: 19GA/ASK-05500-SC3; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-AFH1; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-BMC; EPIDURAL CATHETERIZATION KIT/ASK-05502-NY; EPIDURAL CATHETERIZATION KIT/ASK-17019-RMH

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98793
Lot/product code:
REF(Material)/UDI-DI/Lot(Batch): ASK-05502-VM1/10801902210217, 10801902209938/33F25C0168, 33F25C0880, 33F25E0202, 33F25G0134, 33F25H0126, 33F26C0297, 33F24C0216; AK-05501/)10801902210217, 10801902209501, 10801902209518/33F24E0057, 33F24E0058, 33F24J0496, 33F24K0094, 33F24L0564, 33F25A0460, 33F25A0617, 33F25C0728,33F25E0043, 33F25E0913, 33F25G0081, 33F25H0015, 33F25J0465, 33F25J0822, 33F25K0254, 33F25L0376, 33F26C0300, 33F24B0119; AK-05502/10801902209518, 10801902210217, 10801902209525/33F24C0015, 33F24G0581, 33F24G0582, 33F24G0583, 33F24J0497, 33F24J0678, 33F24J0679, 33F24J0680, 33F24J0681, 33F24K0095, 33F24K0310, 33F24L0580, 33F24L0624, 33F24L0628, 33F24L0630, 33F24L0757, 33F24L0785, 33F25A0461, 33F25A0618, 33F25A0619, 33F25A0620, 33F25C0103, 33F25C0724, 33F25C0725, 33F25C0741, 33F25C0791, 33F25E0044, 33F25E0291, 33F25E0292, 33F25E0293, 33F25E0914, 33F25E1067, 33F25G0082, 33F25G0159, 33F25H0016, 33F25H0197, 33F25H0198, 33F25H0199, 33F25J0466, 33F25J0643, 33F25J0790, 33F25J0805, 33F25J0806, 33F25J0807, 33F25J0808, 33F25K0024, 33F25K0252, 33F25K0358, 33F25K0359, 33F25L0099, 33F25L0266, 33F25L0267, 33F25M0970, 33F25M0978, 33F26A1100, 33F24C0096; AK-05502D/10801902210217, 10801902209532/33F24G0331, 33F24J0498, 33F24K0096, 33F24L0713, 33F25A0462, 33F25C0745, 33F25E0045, 33F25H0017, 33F25J0467, 33F25L0366, 33F24C0017; AK-05503/10801902210217, 10801902209549/33F24J0277, 33F24J0499, 33F24K0097, 33F24L0674, 33F25A0463, 33F25C0949, 33F25E0046, 33F25E0915, 33F25H0018, 33F25J0823, 33F25L0406, 33F25M0912, 33F24C0018; AK-05503-L/10801902209549, 10801902210217, 10801902209549/33F24C0019, 33F24E0066, 33F24J0682, 33F24K0098, 33F24L0613, 33F24L0758, 33F25A0464, 33F25C0104, 33F25C0731, 33F25C0793, 33F25E0047, 33F25E0916, 33F25G0083, 33F25H0019, 33F25H0200, 33F25J0791, 33F25J0809, 33F25K0026, 33F25K0253, 33F25L0057, 33F25L0352, 33F25M0861, 33F26A0989, 33F24J0278; AK-05560/10801902210217, 10801902209556, 30801902121722/33F24J0501, 33F24K0099, 33F24L0552, 33F25A0145, 33F25A0465, 33F25C0743, 33F25E0048, 33F25E0917, 33F25G0084, 33F25H0020, 33F25J0737, 33F25J0824, 33F25M0895, 33F26B0538, 33F26C0592, 33F24A0812; ASK-02520-SBMC1/10801902209570, 10801902210217, 10801902193275/33F24D0103, 33F24F0275, 33F24G0396, 33F25A0137; ASK-05400-BW1/10801902209617, 10801902209631/33F24D0153, 33F24E0474, 33F24G0461, 33F24J0307, 33F24L0556, 33F25B0246, 33F25C0729, 33F25E0178, 33F25G0121, 33F25J0899, 33F25L0042, 33F25L0450, 33F24C0196; ASK-05400-GH/10801902209631, 10801902210217, 10801902202199/33F24D0154, 33F24E0480, 33F24G0292, 33F24J0310, 33F24J0600, 33F24L0597, 33F25A0153, 33F25C0161, 33F25C0754, 33F25E0181, 33F25G0123, 33F25J0532, 33F25L0391, 33F25M0897, 33F24D0155; ASK-05401-LMC/10801902210217, 10801902209662/33F24J0603, 33F25F0240, 33F25G0754, 33F25J0534, 33F24D0031; ASK-05401-NM/10801902210217/33F24E0104, 33F24G0295, 33F24J0311, 33F24J0604, 33F24K0223, 33F24L0559, 33F25A0548, 33F25C0840, 33F25E0184, 33F25G0125, 33F25H0113, 33F25J0535, 33F25L0024, 33F25L0361, 33F24E0027; ASK-05500-BID1/10801902210217/33F24E0490, 33F24G0297, 33F24H0488, 33F24J0607, 33F24L0594, 33F25A0551, 33F25C0823, 33F25E0187, 33F25G0127, 33F25J0536, 33F25L0438, 33F24K0228; ASK-05500-JHH1/10801902210217, 10801902209716, 10801902209723/33F24L0572, 33F25B0379, 33F25D0215, 33F25E0190, 33F25G0129, 33F25H0744, 33F25J0538, 33F25K0407, 33F25M0955, 33S24L0572, 33F24C0203; ASK-05500-MCV1/10801902210217/33F24E0494, 33F24E0495, 33F24G0470, 33F24J0611, 33F24K0229, 33F24L0707, 33F25A0554, 33F25C0784, 33F25E0191, 33F25E1005, 33F25G0761, 33F25H0115, 33F24E0496; ASK-05500-MVH/10801902209730, 10801902210217/33F24D0380, 33F24E0498, 33F24G0472, 33F24L0681; ASK-05500-UMC/10801902209754, 10801902210217/33F24D0382, 33F24J0316, 33F24K0233, 33F24L0085, 33F24L0772, 33F25C0166, 33F25C0737, 33F25E0196, 33F25E0317, 33F25E1008, 33F25H0120, 33F25J0540, 33F25L0397, 33F25M0904, 33F24E0502; ASK-05502-MLH/10801902210217/33F24J0618, 33F24K0239, 33F24L0555, 33F25A0562, 33F25C0996, 33F25E0201, 33F25H0125, 33F25J0544, 33F25L0440, 33F26B0977, 33F24L0583; ASK-05560-JMH1/10801902210217, 10801902209983/33F24G0483, 33F24L0773, 33F25A0566, 33F25C0894, 33F25E1014, 33F25H0130, 33F25J0548, 33F24E0519; ASK-05560-MKD2/10801902193275, 10801902210217/33F24K0246, 33F25G0468, 33F24J0476; ASK-05560-OM1/10801902210217, 10801902210002/33F24K0550, 33F25A0155, 33F25C0171, 33F25F0383, 33F25G0560, 33F25H0131, 33F25H0746, 33F25J0784, 33F25L0006, 33F25M0903, 33F24D0391; ASK-17019-SM/10801902210217, 10801902211221/33F25G0137, 33F25H0136, 33F25J0553, 33F25L0465, 33F24B0348; BP-05501/10801902210217, 10801902193275/33F24E0156, 33F24J0642, 33F24K0270, 33F25B0689, 33F25C0868, 33F25E1034, 33F25G0145, 33F25H0158, 33F25J0568, 33F25L0369, 33F26B0518, 33F25C0444; CK-05401/10801902202144, 10801902210217, 10801902193275/33F24C0256, 33F25A0591, 33F25C0972, 33F25E0256, 33F25E1040, 33F25H0756, 33F25J0935, 33F25L0244, 33F26B0620, 33F25D0674; HS-05501/10801902210217, 10801902202090/33F24E0580, 33F24J0329, 33F24B0389; MM-05501/10… (truncated, 10005 characters total — see the official FDA record for the full value)
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PNHS2

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98793
Lot/product code:
REF(Material)/UDI-DI/Lot(Batch): ASK-42703-PNHS2/10801902193275/33F25J0107; ASK-45703-PNHS2/10801902193275/33F25B0593; ASK-45854-PNHS2/10801902193275/33F24H0128
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYSIS KIT 2L: 14 FR X 20CM AGB/AK-25142-CDC; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UMD; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UNC; HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UMD; HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/ASK-25142-UN1; HEMODIALYSIS KIT: 2L 14 FR X 25 CM/ASK-26142-UMD; HEMODIALYSIS KIT: 2LUMEN 12 FR X 13 CM/AU-23122-F; HEMODIALYSIS KIT: 2LUMEN 12 FR X 20 CM/AU-25122-F; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-X1A; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-XU1A; HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-X1A; HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-X1A; HEMODIALYSIS KIT 2L: 12 FR X 16CM AGB/AK-22122-CDC; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122-F; HEMODIALYSIS KIT: 2-LUMEN 14 FR X 15 CM/AK-22142-F; AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-CN1AC; AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-CN1AU; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-CN1AC;

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98793
Lot/product code:
REF(Material)/UDI-DI/Lot(Batch): AK-11802-F/10801902193275, 10801902197129/33F24G0344, 33F24J0511, 33F24L0637, 33F25A0473, 33F25E0060, 33F25J0473, 33F24A0848; AK-22122/10801902193275/33F24H0232, 33F24J0523; AK-22142-CDC/10801902193275/33F24J0527, 33F24K0129, 33F24L0649, 33F25C0115, 33F25C0959, 33F25E0940, 33F25J0481, 33F25L0428, 33F24G0364; AK-25142-CDC/10801902193275, 50801902123195/33F25A0486, 33F25C0892, 33F25E0086, 33F25E0944, 33F25J0485, 33F25J0845, 33F25L0374, 33F26B0521, 33F25A0487; ASK-22142-UMD/10801902193275, 10801902136470, 10801902143690/33F25F0362, 33F25J0094, 33F26A0244, 33F26B0137, 33F24F0041; ASK-22142-UNC/10801902193275/33F25G0269, 33F24K0560; ASK-25142-UMD/10801902193275, 10801902136500/33F25B0239, 33F25E0308, 33F25G0686, 33F25K0425, 33F26A0246, 33F26C0047, 33F24K0696; ASK-25142-UN1/10801902193275, 10801902156379/33F24L1157, 33F26B0908, 33F25B0420; ASK-26142-UMD/10801902193275, 33F26A0408, 33F25B0427; AU-23122-F/10801902193275/33F25C0877, 33F25H0157, 33F24L0038; AU-25122-F/10801902193275, 70801902123328, 10801902210071/33F25G0562, 33R24L0038, 33F24D0400; CDC-22122-X1A/10801902193275, 10801902213478/33F25E0694, 33F25G0268, 33F24D0693; CDC-22122-XU1A/10801902193275, 10801902168044/33F25E0652, 33F25H0643, 33F24D0830; CDC-22142-X1A/10801902193275/33F25A0284; CDC-26122-X1A/10801902213515/33F24F1028; AK-22122-CDC/10801902193275, 10801902198492/33F24K0125, 33F24L0647, 33F25C0114, 33F25E0936, 33F25G0091, 33F24E0355; AK-22122-F/10801902193275/33F24G0360, 33F24J0524, 33F24K0126, 33F25A0482, 33F25E0075, 33F25E0937, 33F25J0839, 33F25L0413, 33F24G0361; AK-22142-F/10801902193275/33F24L0662, 33F25C0117, 33F25C0865, 33F25H0034, 33F25J0841, 33F24K0130; CDC-22122-CN1AU/10801902193275, 10801902222265/33F26A1388, 33F26B0398, 33F24L0966; CDC-22142-CN1AC/10801902193275/33F26A1550, 33F25J0455; CDC-23122-CN1AU/10801902193275, 10801902222319/33F26A0008, 33F26A1478, 33F26B0397, 33F24L0279; CDC-25122-CN1AU/10801902193275/33F25M0346, 33F25E0882; CDC-25142-CN1AC/30801902123597/36F25B0018
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 21, 2026

GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.

Not guaranteed to be germ-free: Due to FDA inspection observations that it believes may impact product quality.

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▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0492-2026
Lot/product code:
Lot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.
Recalling firm:
Alcon Research LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE KIT/AK-04510-S; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC; ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-BID; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-MAR; ARTERIAL LINE KIT: 20 GA X 5 IN/ASK-04020-PM4; RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)/ASK-04120-HF3; RA CATH SET: 20 GA X 2 1/2 IN (6.35 CM)/ASK-04120-UR; ARTERIAL CATH KIT: 20 GA X 3 1/16 IN/ASK-04125-MGH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04500-HFH4; ARTERIAL LINE KIT: 20GA X 5IN/ASK-04510-BID2; ARTERIAL LINE KIT: 20GA X 5IN (12 CM)/ASK-04510-EHP1; ARTERIAL LINE KIT/ASK-04510-FEM1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-HFH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04510-HFH4; ARTERIAL LINE KIT/ASK-04510-SE; ARTERIAL LINE KIT: 20 GA X 5 IN (12CM)/ASK-04510-TGH2; RA CATH KIT: 20 GA X 12 CM/NA-04550-1A; RA CATH KIT: 20 GA X 12 CM/NA-04550-X1A; RA CATH KIT: 18 GA X 1-3/4IN/AK-04018; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-C; RA CATH KIT: 20 GA X 1-1/2IN/AK-04120; RA CATH KIT: 22 GA X 1-3/8IN/AK-04122; RA CATH KIT: 20 GA X 1-1/2IN/AK-04220; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-AH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-ATH; RA CATH KIT: 20 GA X 1 3/4IN (4.45CM)/ASK-04020-AU2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-BHS; ARTERIAL CATHETERIZATION KIT/ASK-04020-BIDB2; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-CCD1; ARTERIAL CATHETERIZATION KIT/ASK-04020-CR; ART LINE KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-EUH2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FAM1; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FMC; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-KSF2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LM; RA CATH KIT: 20 GA X 1 3/4IN/ASK-04020-MCH1; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MIH1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-NWMX; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-PHP; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-RIHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-RMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-RU; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-SE; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-SHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-SRMC1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UCL1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-UMI; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-UN; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC1; RA CATH SET: 20 GA X 1-1/2IN (3.81CM)/ASK-04220-PSU; RA CATH KIT: 20 GA X 1-1/2 IN (3.81 CM)/ASK-04220-UCL1; RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-S1A; CVC KIT: 20 GA X 5 IN (12CM)/ASK-04550-JMC1; ARTERIAL ACCESS TRAY/ASK-04001-BW2; ARTERIAL ACCESS TRAY WITH .025 IN SWG/ASK-04001-WUH1; ARTERIAL LINE KIT/ASK-04510-HUM

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98793
Lot/product code:
REF(Material)/UDI-DI/Lot(Batch): TJ-04020-1/10801902193275, 30801902202155/33F24J0338, 33F25A0158, 33F25C0753, 33F25E0281, 33F24B0409; NA-04220-S1A/10801902193275/33F25E1052, 33F24G0553; AK-04510-S/10801902192230, 10801902193275, 10801902196719/33F24A0337, 33F24A0338, 33F24A0339, 33F24A0341, 33F24A0342, 33F24A0343, 33F24A1012, 33F24B0107, 33F24B0108, 33F24B0109, 33F24B0110, 33F24B0111, 33F24C0010, 33F24C0011, 33F24D0015, 33F24D0016, 33F24E0046, 33F24E0047, 33F24G0327, 33F24G0570, 33F24G0571, 33F24G0572, 33F24G0573, 33F24G0574, 33F24G0575, 33F24J0493, 33F24J0674, 33F24J0675, 33F24J0676, 33F24J0677, 33F24K0091, 33F24K0309, 33F24K0313, 33F24L0623, 33F24L0627, 33F24L0629, 33F24L0631, 33F24L0754, 33F24L0783, 33F25A0457, 33F25A0613, 33F25A0614, 33F25A0615, 33F25A0616, 33F25C0738, 33F25C0751, 33F25C0794, 33F25C0846, 33F25C0907, 33F25C0955, 33F25C0956, 33F25E0040, 33F25E0288, 33F25E0289, 33F25E0290, 33F25E0910, 33F25E1065, 33F25E1066, 33F25G0079, 33F25G0158, 33F25H0012, 33F25H0193, 33F25H0194, 33F25H0195, 33F25H0196, 33F25J0464, 33F25J0642, 33F25J0789, 33F25J0801, 33F25J0802, 33F25J0803, 33F25J0804, 33F25L0486, 33F25L0488, 33F26B0668, 33F26B0669, 33F26B0671, 33F26B0672, 33F23L0360; ASK-04018-HUMC/10801902193275/33F25B0360, 33F25K0050, 33F25M0680, 33F25E1176; ASK-04018-OH1/10801902117622, 10801902193275, 10801902117622, 10801902117639/33F24F0741, 33F24L0218, 33F24L0865, 33F25B0173, 33F25C0253, 33F25E0667, 33F25F0162, 33F25J0143, 33F26A1440, 33F26B0794, 33F24A0112; ASK-04020-BID/10801902211429, 10801902193275, 10801902211429/33F24D0870, 33F24E0650, 33F24F0646, 33F24L0220, 33F24L0399, 33F25B0175, 33F25D0335, 33F25E0668, 33F25G0248, 33F25L0123, 33F26A0254, 33F26A1441, 33S23J0777, 33F24G0405; ASK-04020-MAR/10801902193275, 10801902159776/33F24J0567, 33F24L0586, 33F25A0519, 33F25E0136, 33F25E0979, 33F25G0675, 33F25J0504, 33F25L0210, 33F26B0742, 33F25K0032; ASK-04020-PM4/10801902138498, 10801902193275, 10801902138498, 30801902158896/33F24E0428, 33F24E0429, 33F24G0424, 33F24K0188, 33F24L0789, 33F25C0142, 33F25C0821, 33F25E0142, 33F25H0085, 33F25J0883, 33F25L0470, 33F26B0659, 33F24F0095; ASK-04120-HF3/10801902200447, 10801902193275, 10801902200447, 10801902117943/33F24D0857, 33F24F0638, 33F24H0168, 33F24K0389, 33F24L0289, 33F25D0336, 33F25F0126, 33F25F0163, 33F25H0616, 33F25J0202, 33F25M0158, 33F25M0362, 33F26A1429, 33F26B0127, 33S24A1516, 33S24C0854, 33F24A0136; ASK-04120-UR/10801902117943, 10801902193275, 10801902117943/33F24A0769, 33F24B0278, 33F24C0175, 33F24D0140, 33F24E0447, 33F24G0287, 33F24K0201, 33F25B0692, 33F25C0962, 33F25E0156, 33F25H0097, 33F25J0889, 33F25L0383, 33F26C0309, 33F24G0441; ASK-04125-MGH/10801902193275, 10801902139976/33F24J0584, 33F25C0985, 33F25D0307, 33F25E0157, 33F25E0990, 33F25H0098, 33F25J0519, 33F25L0421, 33F26A1057, 33F26B0983, 33F24K0203; ASK-04500-HFH4/10801902200461, 10801902193275, 10801902118001/33F24E0651, 33F24F0722, 33F24L0292, 33F25C0437, 33F25D0228, 33F25E0775, 33F25F0109, 33F25F0164, 33F25H0615, 33F25M0345, 33F26A1363, 33F26B0405, 33S24C0436, 33S24L0292, 33F24A0141; ASK-04510-BID2/10801902193275, 10801902211412, 10801902115024/33F24J0171, 33F25A0165, 33F25C0438, 33F25D0229, 33F25E0852, 33F25G0249, 33F25J0204, 33F25M0233, 33F26A1443, 33F26B0410, 33F24F0820; ASK-04510-EHP1/10801902193275, 10801902115024/33F24L0293, 33F25C0192, 33F25D0230, 33F25E0589, 33F25E0853, 33F25H0646, 33F25L0125, 33F26A0255, 33F26A1520, 33F26B0838, 33F24J0303; ASK-04510-FEM1/10801902214796, 10801902193275/33F24A0831, 33F24B0286, 33F24C0185, 33F24E0456, 33F24E0457, 33F24G0448, 33F24J0304, 33F24L0771, 33F25A0539, 33F25E0165, 33F25G0118, 33F25J0523, 33F26A1051, 33F26B0658, 33F24J0591; ASK-04510-HFH/10801902115031, 10801902193275, 10801902200454/33F24G0053, 33F24L0022, 33F24M0108, 33F24M0190, 33F25A0126, 33F25A0356, 33F25A0384, 33F25B0043, 33F25D0200, 33F25H0329, 33F25H0848, 33F25J0613, 33F26A1358, 33F26B0677, 33F24D0865; ASK-04510-HFH4/10801902200454, 10801902193275/33F24F0865, 33F24J0167, 33F24L0965, 33F25A0236, 33F25C0260, 33F25E0776, 33F25G0332, 33F25J0205, 33F25M0276, 33F26A0305, 33F26B0194, 33F24J0306; ASK-04510-SE/10801902193275, 20801902214038, 10801902217018/33F24K0213, 33F24L0592, 33F25B0251, 33F25C0159, 33F25E0171, 33F25J0527, 33F25L0333, 33F26B0664, 33F24A0873; ASK-04510-TGH2/10801902217018, 10801902193275, 10801902118070/33F24B0292, 33F24C0188, 33F24E0463, 33F24G0289, 33F24K0214, 33F24L0633, 33F25A0542, 33F25C0879, 33F25E0172, 33F25G0120, 33F25J0528, 33F25L0354, 33F25M0862, 33F24C0189; NA-04550-1A/30801902117367, 10801902193275, 33F24A1562, 33F24C0709, 33F24D0331, 33F24E0628, 33F24F0946, 33F24K0382, 33F24L0144, 33F24L1015, 33F25C0223, 33F25D0320, 33F25E0512, 33F25E0663, 33F25E0839, 33F25J0187, 33F25K0199, 33F24K0374; NA-04550-X1A/10801902193275, 30801902117374, 10801902119930/33F24K0704, 33F24L0145, 33F24L1138, 33F25C0465, 33F25C0472, 33F25D0633, 33F25G0387, 33F25J0188, 33F25K0200, 33F26C0354, 33F26C0763, 33F24A1326; AK-04018/10801902190915, 10801902193275, 10801902190939/33F24E069… (truncated, 13017 characters total — see the official FDA record for the full value)
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSEL CATH KIT: 20GA X 5IN/AK-04550-S CVC KIT: 1-LUMEN 5 FR X 20 CM/AK-04301-SP CVC KIT: 16 GA X 6IN (16 CM)/AK-04306-SP CVC KIT: 16GA X 6 IN/AK-04800-S CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-12402 CVC KIT: 3-LUMEN 7 FR X 16 CM/AK-12703-CDC CVC KIT: 2L 4 FR X 13 CM/AK-14402 CVC KIT: 2-LUMEN 5 FR X 13 CM/AK-14502 CVC KIT: 3-LUMEN 5.5 FR X 30 CM/AK-14553 CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-14703-SP CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-15402 CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-15553 CVC KIT: 2-LUMEN 4 FR X 30 CM/AK-16402 CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-16553 CVC KIT: 5 FR X 20 CM/ASK-04301-HH2 CVC KIT 3L: 7 FR X 6 IN (16 CM)/ASK-12703-MGH3

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98793
Lot/product code:
REF(Material)/UDI-DI/Lot(Batch): ASK-04510-MM6/10801902193275, 10801902221909/33F25E0590, 33F25G0196, 33F25M0005, 33F25M0149, 33F26A0302, 33F26C0723, 33F24K0212; NA-04020-X1ASP/10801902193275/33F25J0575, 33F25J0756, 33F26B0065, 33F26B0027; ASK-04001-MS/10801902193275/33F24K0706, 33F25F0375, 33F25F0005; ASK-00820-UM1/10801902193275/33F24G0150; AK-04550-S/10801902196719, 10801902193275, 60801902121709/33F24A0029, 33F24A0355, 33F24A1014, 33F24A1619, 33F24B0112, 33F24C0548, 33F24D0017, 33F24E0174, 33F24G0328, 33F24G0576, 33F24J0276, 33F24J0494, 33F24K0092, 33F24L0720, 33F25A0458, 33F25C0950 33F25E0041, 33F25E0911, 33F25G0080, 33F25H0013, 33F25J0820, 33F25L0402, 33F26B0550, 33F26C0267, 33F23M0175; AK-04301-SP/10801902121650, 10801902193275, 10801902121674/33F24A1010, 33F24C0093, 33F24D0068, 33F24E0325, 33F24G0325, 33F24J0274, 33F24K0090, 33F24L0809, 33F25C0757, 33F25E0038, 33F25G0760, 33F25H0721, 33F25J0462, 33F25L0239, 33F25M0888, 33F24A0146; AK-04306-SP/10801902121674, 10801902193275, 10801902192230/33F24A0846, 33F24B0174, 33F24C0094, 33F24E0327, 33F24E0329, 33F24J0275, 33F24J0492, 33F24L0717, 33F25B0249, 33F25C0783, 33F25E0039, 33F25J0463, 33F25L0054, 33F25L0345, 33F26B0684, 33F23J0175; AK-04800-S/60801902121709, 10801902193275, 10801902209501/33F24B0437, 33F24C0735, 33F24E0708, 33F24G0120, 33F24G0647, 33F24H0415, 33F24J0448, 33F24L0037, 33F24M0128, 33F25A0396, 33F25B0111, 33F25D0028, 33F25G0509, 33F25H0326, 33F25J0997, 33F26C0274, 33F24C0013; AK-12402/10801902168471, 10801902193275, 10801902168488/33F24E0342, 33F24F0325, 33F24G0347, 33F24J0512, 33F24K0113, 33F24L0750, 33F25C0109, 33F25C0964, 33F25E0063, 33F25E0926, 33F25J0474, 33F24A0408; AK-12703-CDC/10801902168488, 10801902193275, 10801902168495/33F24A1020, 33F24B0187, 33F24C0104, 33F24D0078, 33F24G0348, 33F24J0513, 33F24K0114, 33F24L0596, 33F25C0110, 33F25C0759, 33F25J0834, 33F25M0948, 33F24A0401; AK-14402/10801902168495, 10801902193275, 10801902168495, 10801902168518/33F24E0177, 33F24E0343, 33F24F0328, 33F24G0349, 33F24J0514, 33F24K0115, 33F25B0369, 33F25C0875, 33F25E0064, 33F25E0928, 33F25H0029, 33F25J0475, 33F26B0564, 33F24A0813; AK-14502/10801902168518, 10801902193275, 30801902122040/33F24E0344, 33F24G0350, 33F24K0116, 33F24L0656, 33F25C0878, 33F25E0065, 33F25G0089, 33F25J0476, 33F26B0568, 33F24A0849; AK-14553/30801902122040, 10801902193275, 10801902122077/33F24B0190, 33F24C0107, 33F24E0345, 33F24E0346, 33F24F0332, 33F24G0351, 33F24K0117, 33F24L0689, 33F25C0112, 33F25C0848, 33F25G0090, 33F25J0835, 33F24B0191; AK-14703-SP/10801902122077, 10801902193275, 10801902197136/33F24E0347, 33F24G0352, 33F24J0516, 33F24K0118, 33F24L0737, 33F25A0476, 33F25C0887, 33F25E0067, 33F25E0929, 33F25J0477, 33F25L0399, 33F25M0905, 33F24D0079; AK-15402/10801902168532, 10801902193275, 10801902168532, 10801902168549/33F24B0194, 33F24E0350, 33F24G0354, 33F24H0034, 33F24J0518, 33F24K0120, 33F24L0751, 33F25A0479, 33F25C0799, 33F25E0069, 33F25E0932, 33F25H0723, 33F25J0836, 33F25L0348, 33F26C0317, 33F24A1268; AK-15553/10801902168549, 10801902193275, 10801902168549, 10801902168563/33F24E0714, 33F24G0226, 33F24G0687, 33F24H0249, 33F24J0353, 33F25B0332, 33F25D0195, 33F25H0796, 33F25J0081, 33F26B0287, 33F24A1269; AK-16402/10801902168563, 10801902193275, 10801902168563, 10801902168570/33F24C0738, 33F24E0715, 33F24H0065, 33F24H0416, 33F24J0212, 33F24J0426, 33F25A0046, 33F25C0087, 33F25C0604, 33F25G0458, 33F25J0082, 33F26A1658, 33F26B0069, 33F26C0446, 33F24A0796; AK-16553/10801902168570, 10801902193275, 30801902122248/33F24E0178, 33F24E0351, 33F24G0355, 33F24J0519, 33F24K0121, 33F24L0790, 33F25C0980, 33F25E0070, 33F25J0478, 33F24C0025; ASK-04301-HH2/10801902193275, 20801902114987/33F25H0640, 33F25K0070, 33F25K0090, 33F24D0733; ASK-12703-MGH3/10801902193275, 10801902115260/33F25D0263, 33F24F0838
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5 FR/ASK-09807-UC; PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2; PSI KIT: 9 FR X 10 CM/ASK-09903-LMDTG; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU5; PSI KIT: 9 FR X 10 CM/CDC-09903-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-KSF2; MAC TWO LUMEN/PSI KIT: 9 FR X 11.5 CM/ASK-11242-KSF1 AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-MCY1; MULTI LUMEN PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU4; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/ASK-21242-UCD1; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-HHC MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDT; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-CCH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-MM2; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29903-DU1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-HHC; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDT; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-NWM; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-SL1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XCN1A; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-HF6; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-HHN1; MULTI LUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-YWH;

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98793
Lot/product code:
REF(Material)/UDI-DI/Lot(Batch): ASK-09701-UP/10801902143874, 10801902193275/33F23K0811, 33F24B0340, 33F24E0524, 33F24G0489, 33F25C0874, 33F25E1018, 33F25H0747, 33F25J0795, 33F26A0402, 33F26B0243, 33F26B1031; ASK-09803-OSU5/10801902193275/33F25D0761, 33F25E0533, 33F25M0683; ASK-09807-UC/10801902145847, 10801902193275/33F24B0018, 33F24F0004, 33F24J0478, 33F25C0175, 33F25E0210, 33F25E1208, 33F25G0676, 33F25L0211; ASK-09903-HH2/10801902193275/33F25E0534, 33F25G0167, 33F25H0565, 33F25J0358, 33F25M0234, 33F26C0332; ASK-09903-LMDTG/10801902193275/33F25E1184, 33F25F0112, 33F25H0375; ASK-09903-OSU5/10801902193275/33F25D0762; CDC-09903-1A/60801902116729, 10801902193275/33F24D0504, 33F24F0227, 33F24H0267, 33F24H0434, 33F24J0219, 33F24K0023, 33F24M0015, 33F24M0109, 33F25B0006, 33F25B0067, 33F25C0417, 33F25D0696, 33F25D0718, 33F25E1148, 33F25F0023, 33F25G0445, 33F25G0513, 33F25G0605, 33F25G0668, 33F26A1644; ASK-11242-KSF2/10801902193275, 10801902222500/33F25D0231, 33F25D0468, 33F25E0592, 33F25K0131, 33F26A1360, 33F26B0425; ASK-11242-KSF1/10801902193275/33F24L0840, 33F25B0190; ASK-21142-NWM/10801902193275, 10801902222746/33F25F0007, 33F25F0173, 33F25J0207, 33F25M0008, 33F26A1438, 33F26B0197; ASK-21242-MCY1/10801902193275, 10801902221022/33F24H0123, 33F25C0342, 33F25E0671, 33F25K0138, 33F26B0441; ASK-21242-OSU4/10801902193275, 10801902222562/33F25D0757, 33F25E0672, 33F25H0445, 33F25H0651, 33F25L0230, 33F26B0795; ASK-21242-UCD1/10801902193275, 10801902221633/33F25E0314, 33F25M0681, 33F26B0138; ASK-21142-HHC/10801902193275, 10801902211450/33F24L0309, 33F25C0273, 33F25G0170, 33F25H0440, 33F25J0372, 33F26B0125; ASK-21242-LMDT/10801902193275, 10801902220698/33F25C0696, 33F25E0544, 33F26A1526, 33F26B0464; ASK-09804-CCH/10801902141023, 10801902193275/33F24D0899, 33F24F0836, 33F24L0295, 33F25B0184, 33F25C0261, 33F25E0777, 33F25G0410, 33F25J0356, 33F26A1369, 33F26C0041; ASK-29803-MM2/10801902193275, 10801902221930/33F25E0549, 33F26A1352, 33F26B0176, 33F26C0031; ASK-29903-DU1/10801902193275/33F24H0139, 33F25A0171, 33F25E0553, 33F25H0426, 33F25M0012; ASK-29903-HHC/10801902193275/33F25D0235, 33F25L0263, 33F26A1431; ASK-29903-LMDT/10801902193275/33F25D0480, 33F25K0208, 33F25K0420; ASK-29903-NWM/10801902193275/33F25F0008, 33F25F0098, 33F25L0264, 33F26A1396; ASK-29903-SL1/10801902193275/33F25C0289, 33F25G0296, 33F25J0104, 33F25J0266, 33F26A1391; CDC-29803-XCN1A/10801902193114, 10801902193275/33F24E0214, 33F24F0024, 33F24F0173, 33F24F0248, 33F24G0163,33F24H0396, 33F24H0431, 33F24L0539, 33F24M0036, 33F24M0113, 33F25A0368, 33F25B0047, 33F25B0118, 33F25B0342, 33F25C0531, 33F25D0708, 33F25D0735, 33F25E1103, 33F25E1154, 33F25F0417, 33F25G0053, 33F25G0514, 33F25H0287, 33F25H0816, 33F25K0293, 33F25L0079, 33F26A1628, 33F26B0565, 33F26C0064, 33F26C0454, 33F26C0099; ASK-29803-HF6/10801902200478,10801902193275/33F24D0625, 33F24F0889, 33F24L0246, 33F25B0441, 33F25D0268, 33F25F0180, 33F25J0151, 33F25M0832; ASK-29804-HHN1/10801902193275/33F25B0236, 33F25E0550, 33F25G0691, 33F25K0053; ASK-21142-YWH/10801902135473/33F25A0440, 33F25D0030;
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS/ASK-45552-RH AGBA PICC NaviCurve: 2L 5.5FR x 55CM BP/DLX-45552-CURVB AGBA PICC NaviCurve: 2L 5.5FR x 55CM TCG/DLX-45552-CURVC AGBA PICC: 2L 5.5FR x 55CM w Biopatch/DLX-45552-HPKB AGBA PICC NaviCurve: 3L 6FR x 55CM BP/DLX-45563-CURVB PI PICC KIT: 4 FR X 50 CM/ASK-35041-NH PI PICC KIT: 2-L 5 FR X 50 CM/ASK-35052-NH PI PICC G4 Stylet: 1L 4FR x 55CM w CHG/DLX-35541-VPSC PI PICC NaviCurve: 2L 5FR x 55CM w BP/DLX-35552-CURVB PI PICC NaviCurve: 3L 6FR x 55CM w BP/DLX-35563-CURVB PI PICC G4 Stylet: 3L 6FR x 55CM w BP/DLX-35563-VPSB AGBA PI PICC KIT: 2L 5.5 FR X 55CM/CDC-45552-HPK1A PI AGBA PICC KIT: 3-L 6 FR X 55 CM/CDC-45563-HPK1A PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI1 PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-VFH1 PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI1 PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-VFH1 PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS/ASK-45563-UWH1 AGBA PICC NaviCurve: 1L 4.5FR x 55CM BP/DLX-45541-CURVB AGBA PICC NaviCurve: 1L 4.5FR x 55CM TCG/DLX-45541-CURVC AGBA PICC G4 Stylet: 1L 4.5FR x 55CM TCG/DLX-45541-VPSC AGBA PICC G4 Stylet: 2L 5.5FR x 55CM BP/DLX-45552-VPSB AGBA PICC G4 Stylet: 2L 5.5FR x 55CM TCG/DLX-45552-VPSC PI PICC:1L 4FR X 50CM PRELOAD VPS STYLET/CDC-35041-VPS PICC KIT: 3 FR X 55 CM/CDC-05531-PK1A

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98793
Lot/product code:
REF(Material)/UDI-DI/Lot(Batch): ASK-44063-NS/10801902193275/33F25F0100; ASK-45052-NS/10801902193275/33F24L0864 ASK-45541-MHBV/10801902193275, 10801902167696/33F25D0410, 33F26C0012, 33S24A0690, 33F25B0574; ASK-45552-RH/10801902193275/33F25B0575, 33F25D0361, 33F25F0197, 33F25K0373, 33F25A0082; DLX-45552-CURVB/10801902193275, 10801902208702/33F25E0506, 33F25E0833, 33F26C0038, 33S24B0518, 33F24L0982; DLX-45552-CURVC/10801902193275, 10801902208733/33F25B0386, 33F25D0381, 33F25D0624, 33F25E0765, 33F25F0225, 33F25H0602, 33F26C0182, 33F25B0390; DLX-45552-HPKB/10801902193275, 10801902208825, 10801902208856/33F25D0454, 33F25D0677, 33F25E0834, 33F25J0446, 33F25M0172, 33F26B0867, 33S24A0586, 33S24A1370, 33F24F0097; DLX-45563-CURVB/10801902193275/33F25C0339, 33F25E0836, 33F25A0321; ASK-35041-NH/10801902221077, 10801902193275/33F26B0140 33F25G0460; ASK-35052-NH/10801902193275/33F25H0412, 33F24L1080; DLX-35541-VPSC/10801902193275/33F25C0449, 33F25D0245, 33F25H0501, 33F24L1148; DLX-35552-CURVB/10801902193275, 10801902208764/33F25C0214, 33F25E0511 ,33F25E0832 ,33F26C0120 33F26C0732, 33F25C0373; DLX-35563-CURVB/10801902193275, 10801902208771/33F25C0337, 33F26B0155, 33F25D0453; DLX-35563-VPSB/10801902193275/33F25C0395; CDC-45552-HPK1A/10801902193275, 10801902188462/33F25D0067, 33F25D0243, 33F25E0452, 33F25E0658, 33F25E0829, 33F26B0891, 33F26C0202, 33S23K0168, 33S24A0419, 33S24A0523, 33S24A1387, 33F25K0317; CDC-45563-HPK1A/10801902193275, 10801902188479/33F25G0283, 33F25H0626, 33S24A0543, 33F24D0497; ASK-45541-UOI1/10801902193275, 10801902221664/33F25H0411, 33F25J0399, 33S24A1368, 33F26A0226; ASK-45541-VFH1/10801902193275, 10801902218886/33F25B0655, 33F25E0573, 33F25G0210, 33F26A1533, 33F26B0841, 33F25G0584; ASK-45552-UOI1/10801902193275/33F26A0227; ASK-45552-VFH1/10801902193275/33F25D0362, 33F25E0866, 33F25J0226, 33F25M0180, 33F26A1455, 33F25H0408; ASK-45563-UWH1/10801902193275/33F25D0660, 33F25J0227, 33F24K0066; DLX-45541-CURVB/10801902193275/33F25B0385, 33F25D0250, 33F25E0760, 33F25J0336, 33F25K0194, 33F24L1115; DLX-45541-CURVC/10801902193275/33F25B0507, 33F25C0216, 33F25E0761, 33F25F0223, 33F25G0362, 33F25J0337, 33F25E0762; DLX-45541-VPSC/10801902193275, 10801902208610/33F24L0390, 33F24L1130, 33F25C0247, 33F25D0251, 33F25D0380, 33F25D0623, 33F25E0764, 33F25E0900, 33F25F0224, 33F25H0604, 33F25J0445, 33F26A1541, 33F26B0460, 33F26C0220, 33F26C0717, 33F25B0387; DLX-45552-VPSB/10801902193275/33F25C0249, 33F25D0253, 33F25D0314, 33F25D0382, 33F24L0392; DLX-45552-VPSC/10801902193275, 10801902208634/33F24L0939, 33F25B0508, 33F25D0254, 33F25D0315, 33F25D0383,33F25D0626, 33F25E0581, 33F25E0709, 33F25E0835, 33F25J0129, 33F25J0257, 33F25M0167, 33F26B0712, 33F26B0937, 33F25B0388; CDC-35041-VPS/10801902186741, 10801902193275/33X25K0001, 33F25E0425; CDC-05531-PK1A/10801902193275, 60801902123420/33F25C0641, 33F25D0435, 33F25E0646, 33F25J0416, 33F26B0711, 33F25D0765
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS/ASK-45552-RH AGBA PICC NaviCurve: 2L 5.5FR x 55CM BP/DLX-45552-CURVB AGBA PICC NaviCurve: 2L 5.5FR x 55CM TCG/DLX-45552-CURVC AGBA PICC: 2L 5.5FR x 55CM w Biopatch/DLX-45552-HPKB AGBA PICC NaviCurve: 3L 6FR x 55CM BP/DLX-45563-CURVB PI PICC KIT: 4 FR X 50 CM/ASK-35041-NH PI PICC KIT: 2-L 5 FR X 50 CM/ASK-35052-NH PI PICC G4 Stylet: 1L 4FR x 55CM w CHG/DLX-35541-VPSC PI PICC NaviCurve: 2L 5FR x 55CM w BP/DLX-35552-CURVB PI PICC NaviCurve: 3L 6FR x 55CM w BP/DLX-35563-CURVB PI PICC G4 Stylet: 3L 6FR x 55CM w BP/DLX-35563-VPSB AGBA PI PICC KIT: 2L 5.5 FR X 55CM/CDC-45552-HPK1A PI AGBA PICC KIT: 3-L 6 FR X 55 CM/CDC-45563-HPK1A PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI1 PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-VFH1 PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI1 PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-VFH1 PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS/ASK-45563-UWH1 AGBA PICC NaviCurve: 1L 4.5FR x 55CM BP/DLX-45541-CURVB AGBA PICC NaviCurve: 1L 4.5FR x 55CM TCG/DLX-45541-CURVC AGBA PICC G4 Stylet: 1L 4.5FR x 55CM TCG/DLX-45541-VPSC AGBA PICC G4 Stylet: 2L 5.5FR x 55CM BP/DLX-45552-VPSB AGBA PICC G4 Stylet: 2L 5.5FR x 55CM TCG/DLX-45552-VPSC PI PICC:1L 4FR X 50CM PRELOAD VPS STYLET/CDC-35041-VPS PICC KIT: 3 FR X 55 CM/CDC-05531-PK1A

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98793
Lot/product code:
REF(Material)/UDI-DI/Lot(Batch): ASK-44063-NS/10801902193275/33F25F0100; ASK-45052-NS/10801902193275/33F24L0864 ASK-45541-MHBV/10801902193275, 10801902167696/33F25D0410, 33F26C0012, 33S24A0690, 33F25B0574; ASK-45552-RH/10801902193275/33F25B0575, 33F25D0361, 33F25F0197, 33F25K0373, 33F25A0082; DLX-45552-CURVB/10801902193275, 10801902208702/33F25E0506, 33F25E0833, 33F26C0038, 33S24B0518, 33F24L0982; DLX-45552-CURVC/10801902193275, 10801902208733/33F25B0386, 33F25D0381, 33F25D0624, 33F25E0765, 33F25F0225, 33F25H0602, 33F26C0182, 33F25B0390; DLX-45552-HPKB/10801902193275, 10801902208825, 10801902208856/33F25D0454, 33F25D0677, 33F25E0834, 33F25J0446, 33F25M0172, 33F26B0867, 33S24A0586, 33S24A1370, 33F24F0097; DLX-45563-CURVB/10801902193275/33F25C0339, 33F25E0836, 33F25A0321; ASK-35041-NH/10801902221077, 10801902193275/33F26B0140 33F25G0460; ASK-35052-NH/10801902193275/33F25H0412, 33F24L1080; DLX-35541-VPSC/10801902193275/33F25C0449, 33F25D0245, 33F25H0501, 33F24L1148; DLX-35552-CURVB/10801902193275, 10801902208764/33F25C0214, 33F25E0511 ,33F25E0832 ,33F26C0120 33F26C0732, 33F25C0373; DLX-35563-CURVB/10801902193275, 10801902208771/33F25C0337, 33F26B0155, 33F25D0453; DLX-35563-VPSB/10801902193275/33F25C0395; CDC-45552-HPK1A/10801902193275, 10801902188462/33F25D0067, 33F25D0243, 33F25E0452, 33F25E0658, 33F25E0829, 33F26B0891, 33F26C0202, 33S23K0168, 33S24A0419, 33S24A0523, 33S24A1387, 33F25K0317; CDC-45563-HPK1A/10801902193275, 10801902188479/33F25G0283, 33F25H0626, 33S24A0543, 33F24D0497; ASK-45541-UOI1/10801902193275, 10801902221664/33F25H0411, 33F25J0399, 33S24A1368, 33F26A0226; ASK-45541-VFH1/10801902193275, 10801902218886/33F25B0655, 33F25E0573, 33F25G0210, 33F26A1533, 33F26B0841, 33F25G0584; ASK-45552-UOI1/10801902193275/33F26A0227; ASK-45552-VFH1/10801902193275/33F25D0362, 33F25E0866, 33F25J0226, 33F25M0180, 33F26A1455, 33F25H0408; ASK-45563-UWH1/10801902193275/33F25D0660, 33F25J0227, 33F24K0066; DLX-45541-CURVB/10801902193275/33F25B0385, 33F25D0250, 33F25E0760, 33F25J0336, 33F25K0194, 33F24L1115; DLX-45541-CURVC/10801902193275/33F25B0507, 33F25C0216, 33F25E0761, 33F25F0223, 33F25G0362, 33F25J0337, 33F25E0762; DLX-45541-VPSC/10801902193275, 10801902208610/33F24L0390, 33F24L1130, 33F25C0247, 33F25D0251, 33F25D0380, 33F25D0623, 33F25E0764, 33F25E0900, 33F25F0224, 33F25H0604, 33F25J0445, 33F26A1541, 33F26B0460, 33F26C0220, 33F26C0717, 33F25B0387; DLX-45552-VPSB/10801902193275/33F25C0249, 33F25D0253, 33F25D0314, 33F25D0382, 33F24L0392; DLX-45552-VPSC/10801902193275, 10801902208634/33F24L0939, 33F25B0508, 33F25D0254, 33F25D0315, 33F25D0383,33F25D0626, 33F25E0581, 33F25E0709, 33F25E0835, 33F25J0129, 33F25J0257, 33F25M0167, 33F26B0712, 33F26B0937, 33F25B0388; CDC-35041-VPS/10801902186741, 10801902193275/33X25K0001, 33F25E0425; CDC-05531-PK1A/10801902193275, 60801902123420/33F25C0641, 33F25D0435, 33F25E0646, 33F25J0416, 33F26B0711, 33F25D0765
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CVC KIT: 7 FR X 16 CM/ASK-12703-PNM; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PUMH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/CDC-15703-P1A; PI CVC KIT: 3-L 7 FR X 6IN (16 CM)/NA-12703-PCDC; PI CVC KIT: 3-L 7 FR X 8IN (20 CM)/NA-15703-PCDC; CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-25553; 2-L CVC KIT: 4 FR X 5 CM/CDC-22402-X1A; 2-L CVC KIT: 5 FR X 5 CM/CDC-22502-X1A; 2-L CVC KIT: 4 FR X 8 CM/CDC-25402-X1A; 2-L CVC KIT: 5 FR X 8 CM/CDC-25502-X1A; 3-L CVC KIT: 5.5 FR X 8 CM/CDC-25553-X1A; 3-L CVC KIT: 5.5 FR X 13 CM/CDC-26553-X1A; CVC KIT 3L: 12 FR X 16 CM AGB/AK-22123-CDC; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-22123-F; CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-22402; CVC KIT: 2-LUMEN 5 FR X 5 CM/AK-22502; CVC KIT: 16 GA X 8IN/AK-24301-SK; CVC KIT: 2-LUMEN 4 FR X 13 CM/AK-24402; CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-24703-ASK; CVC KIT 3L: 12FR X 20 CM AGB/AK-25123-CDC; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-25123-F; CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-25402; CVC KIT: 2-LUMEN 5 FR X 8 CM/AK-25502; CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-26553; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-1A; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-X1A; CVC KIT: 16 GA X 20 CM/CDC-24301-1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/AK-22702-P1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/CDC-22702-XP1A; CVC KIT: 3L 7 FR X 20 CM/ASK-45703-CPR; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-AKP1A; MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6IN/ASK-42703-KH; PI CVC KIT: 3L 7FR X 16CM AGB+/ASK-42703-MGH1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-PCCH2; PI CVC KIT: 3LUMEN 7 FR X 6IN (16 CM)/ASK-42703-PFS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNO2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-PSCH1; MULTILUMEN PI CVC KIT: 2L 8 FR X 16 CM/ASK-42802-AKP1A; CVC KIT: 2L 8 FR X 16CM/ASK-42802-LMDTG1; PI CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-PUCI1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUMH; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UMM; PI CVC KIT: 4-L 8.5 FR X 6 IN/ASK-42854-AKP1A; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-MGH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-AKP1A; PI CVC KIT: 3L 7 FR X 20CM AGB+/ASK-45703-MGH; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PCCH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PECL1; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PFS1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PHM1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PHU; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PNCB; MULTILUMEN CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PPCM; PI CVC KIT: 3-LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PSJ2; PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PSVM; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PUHS; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PUKL; PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PUMF1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM)/ASK-45703-PUR1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-RHR1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-WA; MULTI LUMEN PI CVC KIT: 2L 8 FR X 8 IN/ASK-45802-AKP1A; PI CVC KIT: 4L 8.5 FR X 20 CM/ASK-45854-AKP1A; PI CVC KIT: 4L 8.5FR X 20CM AGB+/ASK-45854-MGH; PI CVC KIT: 4L 8.5 FR X 8IN/ASK-45854-PCCH2; CVC KIT: 4L 8.5 FR X 20 CM AGB/ASK-45854-PNM; MULTI LUMEN CVC KIT: 4L 8.5 FR X 8 IN/ASK-45854-PPCM; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PUCH2; MULTILUMEN PI CVC KIT: 2L 7 FR X 20 CM/ASK-46702-PWBH1; MULTILUMEN CVC KIT: 2L 8 FR X 16 CM/CDC-42802-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB/CDC-45703-PA1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL4; PI CVC KIT: 3-L 7 FR X 16 CM AGB+/AK-42703-P1A; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/AK-42802-P1A; PI CVC KIT: 4-L 8.5 FR X 16 CM AGB+/AK-42854-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/AK-45703-P1A; PI CVC KIT: 2-L 8 FR X 20 CM AGB

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98793
Lot/product code:
REF(Material)/UDI-DI/Lot(Batch): ASK-42802-PLH/10801902193275, 10801902133110, 10801902212013/33F25L0140 33F26B0222, 33F24F0799; AK-12123-F/10801902168464, 10801902193275, 10801902186338/33F24B0185, 33F24C0102, 33F24D0077, 33F24F0323, 33F24G0346, 33F24K0112, 33F25C0929, 33F25E0062, 33F25H0028, 33F25J0833, 33F24G0129; AK-15123-F/10801902168525, 10801902193275, 10801902186499/33F24C0108, 33F24E0349, 33F24G0353, 33F24L0650, 33F25A0478, 33F25C0779, 33F25E0068, 33F25M0946, 33F24E0713; ASK-12703-PMAH/10801902193275/33F24J0116; ASK-12703-PNM/10801902193275, 10801902214338/33F24L0197, 33F24D0725; ASK-12703-PUMH/10801902193275, 10801902164602/33F25L0030, 33F24F0914; ASK-15703-PRH/10801902193275, 10801902133226/33F25C0271, 33F25F0168, 33F25J0101, 33F25J0368, 33F26A1500, 33F24C0858; CDC-15703-P1A/10801902116793, 10801902193275/33F24D0980, 33F24E0236, 33F24E0832, 33F24G0252, 33F24H0074, 33F24H0401, 33F24H0457, 33F24J0195, 33F24K0024, 33F24M0016, 33F24M0017, 33F24M0064, 33F25B0116, 33F25C0577, 33F25D0719, 33F25G0427, 33F25G0441, 33F25G0663, 33F25H0361, 33F25J1039, 33F25M0495, 33F25M0512, 33F25B0670; NA-12703-PCDC/10801902193275, 10801902119978, 10801902119985/33F24G0555, 33F24K0298, 33F25A0602, 33F25E1055, 33F25H0180, 33F25J0942, 33F25L0474, 33F26B0598, 33F24D0414; NA-15703-PCDC/10801902119985, 10801902193275, 10801902119985, 10801902210217/33F24F0191, 33F24G0556, 33F24J0336, 33F24K0572, 33F25A0157, 33F25C0200, 33F25C0833, 33F25E0275, 33F25H0181, 33F25H0762, 33F25J0943, 33F25L0456, 33F26B0587, 33F25A0603; AK-25553/10801902193275, 10801902167801/33F24H0250, 33F24M0062, 33F25A0382, 33F25B0310, 33F25C0069, 33F25C0506, 33F26C0405, 33F24G0377; CDC-22402-X1A/)10801902193275/33F25K0177, 33F26B0893, 33F25E1192; CDC-22502-X1A/10801902193275/33F25F0216, 33F25C0331; CDC-25402-X1A/10801902193275, 20801902116974/33F25A0287, 33F25D0505, 33F25E0824, 33F25H0569, 33F26A1470, 33F26B0216, 33F24L0486; CDC-25502-X1A/10801902193275/33F24L0980, 33F25D0506, 33F25E0698, 33F25G0315, 33F25J0429, 33F26A1472, 33F24L0832; CDC-25553-X1A/10801902193275, 10801902168129, 60801902123611/33F25E0890, 33F25E1191, 33F26A1384, 33F26B0708, 33F24F0084; CDC-26553-X1A/10801902193275, 10801902168136, 50801902117019/33F25E0749, 33F25E1190, 33F25J0432, 33F26B0807, 33F26C0210, 33F26D0063, 33F24D0807; AK-22123-CDC/10801902193275, 10801902167740/33F24K0127, 33F25A0483, 33F25E0076, 33F25E0938, 33F25H0032, 33F25J0480, 33F25K0398, 33F25M0960, 33F24E0358; AK-22123-F/10801902193275/33F24G0362, 33F24J0526, 33F24K0128, 33F24L0762, 33F25C0963, 33F25E0939, 33F25H0033, 33F24G0363; AK-22402/10801902193275, 10801902167764/33F24L0704, 33F25A0484, 33F25C0817, 33F25E0079, 33F25H0035, 33F25L0373, 33F25M0879, 33F24B0203; AK-22502/10801902193275, 10801902167764/33F24E0363, 33F24G0366, 33F24K0131, 33F24L0708, 33F25C0885, 33F25J0842, 33F24K0487; AK-24301-SK/10801902193275/33F24G0367, 33F24J0528, 33F24K0132, 33F24L0680, 33F25C0118, 33F25C0775, 33F25E0080, 33F25G0092, 33F25H0036, 33F25H0724, 33F25J0482, 33F25L0411, 33F25M0915, 33F24K0133; AK-24402/10801902193275/33F24L0059, 33F24L0727, 33F25C0119, 33F25C0976, 33F25E0081, 33F24K0134; AK-24703-ASK/10801902193275, 10801902118971, 60801902123178/33F24L0778, 33F25C0928, 33F25E0082, 33F25H0037, 33F25J0843, 33F26B0495, 33F24F0281; AK-25123-CDC/10801902193275/33F24K0136, 33F24L0730; AK-25123-F/10801902193275/33F25C0913, 33F25E0085, 33F25E0943, 33F25J0484, 33F26B0496, 33F24G0374; AK-25402/10801902193275, 10801902167795/33F24G0376, 33F24J0282, 33F24K0139, 33F24L0752, 33F25C0121, 33F25C0968, 33F25G0093, 33F25J0486, 33F25L0381, 33F26B0532, 33F24G0688; AK-25502/10801902193275, 10801902180381/33F24H0051, 33F24M0001, 33F25A0125, 33F25B0333, 33F25F0256, 33F25F0500, 33F25H0807, 33F25K0228, 33F25L0163, 33F26A0051, 33F26B0266, 33F24G0689; AK-26553/10801902193275, 20801902117506/33F24K0140, 33F24L0776, 33F25E0089, 33F25G0094, 33F25J0847, 33F25L0410, 33F25M0914, 33F24D0024; CDC-22123-1A/10801902168044, 10801902193275/33F24F0943, 33F24L0472, 33F25A0325, 33F25B0672, 33F25E0653, 33F25E0877, 33F25M0114, 33F25M0424, 33F26A1508, 33F25A0326; CDC-22123-X1A/10801902193275, 20801902116851, 20801902116851,10801902213591/33F25B0673, 33F25D0446, 33F25D0667, 33F25F0212, 33F25G0413, 33F25J0317, 33F25M0396, 33F26B0442, 33F24D0842; CDC-24301-1A/30801902116902, 10801902193275, 30801902116902, 30801902116919/33F24D0874, 33F24F0076, 33F24F0863, 33F24K0501, 33F24L0979, 33F25B0617, 33F25D0494, 33F25D0668, 33F25E0697, 33F25E0820, 33F25H0571, 33F25J0249, 33F25K0181, 33F25L0084, 33F25L0104, 33F26A1413, 33F26B0784, 33S25E0697, 33F24C0702; AK-22702-P1A/10801902193275, 30801902122378/33F25D0322, 33F25H0424, 33F25J0097, 33F25K0085, 33F24E0364; CDC-22702-XP1A/10801902193275, 30801902116896/33F25D0451, 33F25F0217, 33F25H0573, 33F25J0322, 33F26A1386, 33F26B0706, 33F25K0180; ASK-45703-CPR/10801902193275/33F24J0477, 33F24L1068; ASK-42703-AKP1A/10801902193275, 10801902202519/33F24J0324, 33F25A0577, 33F25C0841, 33F25E0233, 33F25E1027, 33F25G0140, 33F25H0148, 3… (truncated, 12834 characters total — see the official FDA record for the full value)
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98793
Lot/product code:
REF(Material)/UDI-DI/Lot(Batch): AI-06210-KS/10801902210217, 10801902211504/33F24G0127, 33F24H0302, 33F25E0321, 33F26A1322, 33F25B0008; AI-07155-KS/10801902210217, 10801902211481, 10801902197938/33F25B0056, 33F25C0574, 33F25D0190, 33F25D0688, 33F25E0387, 33F25E0467, 33F25E1140, 33F25E1211, 33F25G0708, 33F25H0269, 33F25H0319, 33F25H0357, 33F25J0606, 33F25L0085, 33F25L0313, 33F26A0018, 33F26A1258, 33F26A1305, 33F26B0256, 33F26B0731, 33F26B0938, 33F26C0063, 33F26C0271, 33F26C0537, 33F24D0003; ASK-07155-UPM/10801902210217, 10801902203172/33F25E0208, 33F25H0134, 33F25J0913, 33F25M0051, 33F23L0622
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled April 20, 2026

Buttermilk Powder - paper bags 25 kg. (packed under 1 label: BMP Extra Grade Standard)

Potential contamination with Salmonella.

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0700-2026
Lot/product code:
Batch Codes for recalled product all start with A or B full list below. Batch Codes and Production Date: A22525-08-A 8/13/2025; A22525-08-B 8/13/2025; A22525-08-C 8/13/2025; A22525-08-D 8/13/2025; A22525-08-E 8/13/2025; A22525-08-F 8/13/2025; A22525-08-G 8/13/2025; A22525-08-H 8/13/2025.
Recalling firm:
California Dairies Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Allia Moveo angiographic X-ray system

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

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FDA has not published a risk classification for this recall yet.

Recall #:
98880
Lot/product code:
UDI-DI: 00198953052488; Serial Numbers: C4-25-001, C4-25-002, C4-26-001, C4-26-002, C4-26-004, C4-26-005
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Allia IGS Pulse angiographic X-ray system

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98880
Lot/product code:
UDI-DI: 00195278827647; Serial Numbers: DVMSS2500001HL, DVMSS2500002HL, DVMSS2500003HL, DVMSS2500004HL, DVMSS2500005HL, DVMSS2500006HL, DVMSS2600001HL, DVMSS2600002HL
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
99007
Lot/product code:
Lot Code: UDI (01)00840311346288(0812)8.00 Software Version 8.00 The software error occurs if a customer generated an IOD for a toric implantation from April 13, 2026 to April 16, 2026 for multiple toric lens reservations for the same eye using the STAAR ICL Calculation Software.
Recalling firm:
Staar Surgical AG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Allia IGS 3 Pulse angiographic X-ray system

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

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FDA has not published a risk classification for this recall yet.

Recall #:
98880
Lot/product code:
UDI-DI: 00195278719577; Serial Numbers: M3-24-053, M3-24-124, M3-25-029, M3-25-051, M3-25-053, M3-25-091, M3-25-098, M3-25-124, M3-26-010, M3-26-030
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Allia IGS 5 Pulse angiographic X-ray system

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98880
Lot/product code:
UDI-DI: 00195278719263; Serial Numbers: M2-23-039, M2-23-056, M2-24-004, M2-24-019, M2-24-020, M2-24-025, M2-24-030, M2-24-031, M2-24-032, M2-24-033, M2-24-034, M2-24-037, M2-24-038, M2-24-039, M2-24-040, M2-24-046, M2-24-057, M2-24-062, M2-24-064, M2-24-066, M2-24-069, M2-24-071, M2-24-077, M2-24-078, M2-24-080, M2-24-083, M2-25-003, M2-25-004, M2-25-005, M2-25-011, M2-25-013, M2-25-015, M2-25-017, M2-25-019, M2-25-023, M2-25-024, M2-25-025, M2-25-026, M2-25-028, M2-25-032, M2-25-036, M2-25-037, M2-25-039, M2-25-040, M2-25-041, M2-25-042, M2-25-043, M2-25-046, M2-25-048, M2-25-049, M2-25-056, M2-25-057, M2-25-058, M2-25-062, M2-25-065, M2-25-067, M2-25-072, M2-25-074, M2-25-077, M2-25-078, M2-25-080, M2-25-250, M2-25-300, M2-26-002, M2-26-004, M2-26-006, M2-26-007, M2-UP2502, M3-22-012, M3-23-117, M3-24-019, M3-24-021, M3-24-023, M3-24-034, M3-24-052, M3-24-061, M3-24-074, M3-24-079, M3-24-086, M3-24-090, M3-24-094, M3-24-095, M3-24-097, M3-24-099, M3-24-101, M3-24-104, M3-24-111, M3-24-120, M3-24-128, M3-24-136, M3-24-137, M3-24-141, M3-24-143, M3-24-149, M3-24-151, M3-24-156, M3-24-159, M3-24-161, M3-24-163, M3-24-165, M3-24-168, M3-24-169, M3-24-172, M3-24-175, M3-25-003, M3-25-012, M3-25-017, M3-25-020, M3-25-027, M3-25-036, M3-25-061, M3-25-063, M3-25-069, M3-25-074, M3-25-076, M3-25-079, M3-25-080, M3-25-084, M3-25-085, M3-25-088, M3-25-089, M3-25-094, M3-25-104, M3-25-106, M3-25-107, M3-25-115, M3-25-118, M3-25-119, M3-25-120, M3-25-128, M3-25-130, M3-25-132, M3-25-145, M3-25-147, M3-25-148, M3-25-149, M3-25-150, M3-25-151, M3-26-002, M3-26-003, M3-26-005, M3-26-007, M3-26-021, M3-26-024, M3-26-027, M3-26-028, M3-26-033, M3-26-034, M3-UP2501, M3-UP2503
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled April 20, 2026

Low Heat Non-Fat Dried Milk Powder - paper bags 25 kg. (packed under 5 labels: Off Grade NFDM Variable; Extra Grade NFDM Standard rBST Free; Grade A NFDM LH Basic; Grade A NFDM LH Standard rBST Free; Grade A NFDM LH Tier 1 rBST Free)

Potential contamination with Salmonella.

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0699-2026
Lot/product code:
Batch Codes for recalled product all start with A or B full list below. Batch Codes and Production Date: B22725-01-A 8/15/2025; B22725-01-B 8/15/2025; B22725-01-C 8/15/2025; B22725-01-D 8/15/2025; B22725-01-E 8/15/2025; B22725-01-F 8/15/2025; B22725-01-G 8/15/2025; B22725-01-H 8/15/2025; B22825-01-A 8/16/2025; B22825-01-B 8/16/2025; B22825-02-A 8/16/2025; B22825-02-B 8/16/2025; B22825-02-C 8/16/2025; B22825-02-D 8/16/2025; B22825-02-E 8/16/2025; B22825-02-F 8/16/2025; B22825-02-G 8/16/2025; B22825-02-H 8/16/2025; B22825-03-A 8/16/2025; B22825-03-B 8/16/2025; B22825-03-C 8/16/2025; B22825-03-D 8/16/2025; B22825-03-E 8/16/2025; B22825-03-F 8/16/2025; B22825-03-G 8/16/2025; B22825-03-H 8/16/2025; B22825-04-A 8/16/2025; B22825-04-B 8/16/2025; B22825-04-C 8/16/2025; B22825-04-D 8/16/2025; B22825-04-E 8/16/2025; B22825-04-F 8/16/2025; B22825-04-G 8/16/2025; B22825-04-H 8/16/2025; B22825-05-A 8/16/2025; B22825-05-B 8/16/2025; B22825-05-C 8/16/2025; B22825-05-D 8/16/2025; B22825-05-E 8/16/2025; B22825-05-F 8/16/2025; B22825-05-G 8/16/2025; B22825-05-H 8/16/2025; B22925-05-A 8/17/2025; B22925-05-B 8/17/2025; B22925-05-C 8/17/2025; B22925-05-D 8/17/2025; B22925-05-E 8/17/2025; B22925-05-F 8/17/2025; B22925-05-G 8/17/2025; B22925-05-H 8/17/2025; B22925-06-A 8/17/2025; B22925-06-B 8/17/2025; B22925-06-C 8/17/2025; B22925-06-D 8/17/2025; B22925-06-E 8/17/2025; B22925-06-F 8/17/2025; B22925-06-G 8/17/2025; B22925-06-H 8/17/2025; B23025-01-A 8/18/2025; B23025-01-B 8/18/2025; B23025-01-C 8/18/2025; B23025-01-D 8/18/2025; B23025-01-E 8/18/2025; B23025-01-F 8/18/2025; B23025-01-G 8/18/2025; B23025-01-H 8/18/2025; B23025-02-A 8/18/2025; B23025-02-B 8/18/2025; B23025-02-C 8/18/2025; B23025-02-D 8/18/2025; B23025-02-E 8/18/2025; B23025-02-F 8/18/2025; B23025-02-G 8/18/2025; B23025-02-H 8/18/2025; B23025-03-A 8/18/2025; B23025-03-B 8/18/2025; B23025-03-C 8/18/2025; B23025-03-D 8/18/2025; B23025-03-E 8/18/2025; B23025-03-F 8/18/2025; B23025-03-G 8/18/2025; B23025-03-H 8/18/2025; B23025-04-A 8/18/2025; B23025-04-B 8/18/2025; B23025-04-C 8/18/2025; B23025-04-D 8/18/2025; B23025-04-E 8/18/2025; B23025-04-F 8/18/2025; B23025-04-G 8/18/2025; B23025-04-H 8/18/2025; B23125-10-A 8/19/2025; B23125-10-B 8/19/2025; B23125-10-C 8/19/2025; B23125-10-D 8/19/2025; B23125-10-E 8/19/2025; B23125-10-F 8/19/2025; B23125-10-G 8/19/2025; B23125-10-H 8/19/2025; B23425-02-A 8/22/2025; B23425-02-B 8/22/2025; B23425-02-C 8/22/2025; B23425-02-D 8/22/2025; B23425-02-E 8/22/2025; B23425-02-F 8/22/2025; B23425-02-G 8/22/2025; B23425-02-H 8/22/2025; B23425-03-A 8/22/2025; B23425-03-B 8/22/2025; B23425-03-C 8/22/2025; B23425-03-D 8/22/2025; B23425-03-E 8/22/2025; B23425-03-F 8/22/2025; B23425-03-G 8/22/2025; B23425-03-H 8/22/2025; B23625-01-A 8/24/2025; B23625-01-B 8/24/2025; B23625-01-C 8/24/2025; B23625-01-D 8/24/2025; B23625-01-E 8/24/2025; B23625-01-F 8/24/2025; B23625-01-G 8/24/2025; B23625-01-H 8/24/2025; B23625-02-A 8/24/2025; B23625-02-B 8/24/2025; B23625-02-C 8/24/2025; B23625-02-D 8/24/2025; B23625-02-E 8/24/2025; B23625-02-F 8/24/2025; B23625-02-G 8/24/2025; B23625-02-H 8/24/2025; B23925-05-A 8/27/2025; B23925-05-B 8/27/2025; B23925-05-C 8/27/2025; B23925-05-D 8/27/2025; B23925-05-E 8/27/2025; B23925-05-F 8/27/2025; B23925-05-G 8/27/2025; B23925-05-H 8/27/2025; B23925-06-A 8/27/2025; B23925-06-B 8/27/2025; B23925-06-C 8/27/2025; B23925-06-D 8/27/2025; B23925-06-E 8/27/2025; B23925-06-F 8/27/2025; B23925-06-G 8/27/2025; B23925-06-H 8/27/2025; B24025-06-A 8/28/2025; B24025-06-B 8/28/2025; B24025-06-C 8/28/2025; B24025-06-D 8/28/2025; B24025-06-E 8/28/2025; B24025-06-F 8/28/2025; B24025-06-G 8/28/2025; B24025-06-H 8/28/2025; B24025-07-A 8/28/2025; B24025-07-B 8/28/2025; B24025-07-C 8/28/2025; B24025-07-D 8/28/2025; B24025-07-E 8/28/2025; B24025-07-F 8/28/2025; B24025-07-G 8/28/2025; B24025-07-H 8/28/2025; B24125-01-A 8/29/2025; B24125-01-B 8/29/2025; B24125-01-C 8/29/2025; B24125-01-D 8/29/2025; B24125-01-E 8/29/2025; B24125-01-F 8/29/2025; B24125-01-G 8/29/2025; B24125-01-H 8/29/2025; B24125-02-A 8/29/2025; B24125-02-B 8/29/2025; B24125-02-C 8/29/2025; B24125-02-D 8/29/2025; B24125-02-E 8/29/2025; B24125-02-F 8/29/2025; B24125-02-G 8/29/2025; B24125-02-H 8/29/2025; B24125-03-A 8/29/2025; B24125-03-B 8/29/2025; B24125-03-C 8/29/2025; B24125-03-D 8/29/2025; B24125-03-E 8/29/2025; B24125-03-F 8/29/2025; B24125-03-G 8/29/2025; B24125-03-H 8/29/2025; B24125-04-A 8/29/2025; B24125-04-B 8/29/2025; B24125-04-C 8/29/2025; B24125-04-D 8/29/2025; B24125-04-E 8/29/2025; B24125-04-F 8/29/2025; B24125-04-G 8/29/2025; B24125-04-H 8/29/2025; B24125-05-A 8/29/2025; B24125-05-B 8/29/2025; B24125-05-C 8/29/2025; B24125-05-D 8/29/2025; B24125-05-E 8/29/2025; B24125-05-F 8/29/2025; B24125-05-G 8/29/2025; B24125-05-H 8/29/2025; B24125-06-A 8/29/2025; B24125-06-B 8/29/2025; B24125-06-C 8/29/2025; B24125-06-D 8/29/2025; B24125-06-E 8/29/2025; B24125-06-F 8/29/2025; B24125-06-G 8/29/2025; B24125-06-H 8/29/2025; B24125-07-A 8/29/2025; B24125-07-B 8/29/2025; B24125-07-C 8… (truncated, 15041 characters total — see the official FDA record for the full value)
Recalling firm:
California Dairies Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Allia IGS 7 Pulse angiographic X-ray system

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98880
Lot/product code:
UDI-DI: 00195278719720; Serial Numbers: D3-23-024, D3-23-029, D3-24-001, D3-24-002, D3-24-005, D3-24-006, D3-24-008, D3-24-009, D3-24-010, D3-24-013, D3-24-014, D3-24-016, D3-24-019, D3-24-020, D3-24-021, D3-24-023, D3-24-025, D3-25-001, D3-25-002, D3-25-003, D3-25-005, D3-25-006, D3-25-007, D3-25-008, D3-25-009, D3-25-010, D3-25-013, D3-25-016, D3-25-017, D3-25-018, D3-25-026, D3-25-027, D3-25-029, D3-25-030, D3-25-034, D3-25-036, D3-25-037, D3-26-001, D3-26-002, D3-26-007
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Automated Impella Controller (AIC); Product Code: 0042-0000-US;

A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.

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FDA has not published a risk classification for this recall yet.

Recall #:
98770
Lot/product code:
Product Code: 0042-0000-US; UDI-DI: 00813502010022; Serial Numbers: IC2449, IC2451, IC2452, IC2453, IC2459, IC2460, IC1096, IC1142, IC1202, IC1203, IC1224, IC1231, IC1238, IC1284, IC1285, IC1390, IC1545, IC1577, IC1665, IC1708, IC1741, IC1852, IC1853, IC2029, IC2071, IC2154, IC2277, IC2278, IC2314, IC2315, IC2368, IC2369, IC2370, IC2442, IC2443, IC2444, IC2461, IC2471, IC2476, IC2477, IC2478, IC2479, IC2575, IC2989, IC3127, IC3128, IC3129, IC3130, IC3166, IC3167, IC3213, IC3223, IC3306, IC3307, IC3308, IC3309, IC3342, IC3398, IC3475, IC3656, IC3658, IC3663, IC3664, IC3665, IC3666, IC3674, IC3675, IC3719, IC3720, IC3776, IC3812, IC3887, IC3888, IC4045, IC4060, IC1301, IC1544, IC1572, IC2686, IC2687, IC2848, IC3174, IC3269, IC3272, IC3277, IC3278, IC3281, IC3282, IC3284, IC3294, IC3783;
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugChemicalRecalled April 20, 2026

NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16

Chemical contamination; presence of lead and lithium above specification

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A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0523-2026
Lot/product code:
Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Recalling firm:
Acella Pharmaceuticals, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx device cleared by the US FDA for Whole Slide Imaging purposes. Roche Digital Pathology Dx is an automated digital slide creation, viewing, and management system.

Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window

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FDA has not published a risk classification for this recall yet.

Recall #:
98998
Lot/product code:
navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ Software version Numbers: 2.5.0, 2.5.0.1, 2.5.0.2, and 2.5.1
Recalling firm:
Ventana Medical Systems, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled April 20, 2026

Low Heat Non-Fat Dried Milk Powder - plastic totes (NTE) 2200 lbs. (packed under 5 labels: Off Grade NFDM Variable; Grade A NFDM LH Basic; Grade A NFDM LH Green Loop rBST Free; Grade A NFDM LH Standard NC rBST Free; NFDM LH Variable Standard)

Potential contamination with Salmonella.

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0698-2026
Lot/product code:
Batch Codes for recalled product all start with A or B full list below. Batch Code and Production Date: B22625-01-1 8/14/2025; B22625-01-2 8/14/2025; B22625-01-3 8/14/2025; B22625-01-4 8/14/2025; B22625-01-5 8/14/2025; B22625-01-6 8/14/2025; B22625-01-7 8/14/2025; B22625-01-8 8/14/2025; B22625-02-1 8/14/2025; B22625-02-2 8/14/2025; B22625-02-3 8/14/2025; B22625-02-4 8/14/2025; B22625-02-5 8/14/2025; B22625-02-6 8/14/2025; B22625-02-7 8/14/2025; B22625-02-8 8/14/2025; B22625-03-1 8/14/2025; B22625-03-2 8/14/2025; B22625-03-3 8/14/2025; B22625-03-4 8/14/2025; B22625-03-5 8/14/2025; B22625-03-6 8/14/2025; B22625-03-7 8/14/2025; B22625-03-8 8/14/2025; B22625-04-1 8/14/2025; B22625-04-2 8/14/2025; B22625-04-3 8/14/2025; B22625-04-4 8/14/2025; B22625-04-5 8/14/2025; B22625-04-6 8/14/2025; B22625-04-7 8/14/2025; B22625-04-8 8/14/2025; B22625-05-1 8/14/2025; B22625-05-2 8/14/2025; B22625-05-3 8/14/2025; B22625-05-4 8/14/2025; B22625-05-5 8/14/2025; B22625-05-6 8/14/2025; B22625-05-7 8/14/2025; B22625-05-8 8/14/2025; B22625-06-1 8/14/2025; B22625-06-2 8/14/2025; B22625-06-3 8/14/2025; B22625-06-4 8/14/2025; B22625-06-5 8/14/2025; B22625-06-6 8/14/2025; B22625-06-7 8/14/2025; B22625-06-8 8/14/2025; B22625-07-1 8/14/2025; B22625-07-2 8/14/2025; B22625-07-3 8/14/2025; B22625-07-4 8/14/2025; B22625-07-5 8/14/2025; B22625-07-6 8/14/2025; B22625-07-7 8/14/2025; B22625-07-8 8/14/2025; B22625-08-1 8/14/2025; B22625-08-2 8/14/2025; B22625-08-3 8/14/2025; B22625-08-4 8/14/2025; B22625-08-5 8/14/2025; B22625-08-6 8/14/2025; B22625-08-7 8/14/2025; B22625-08-8 8/14/2025; B22625-09-1 8/14/2025; B22625-09-2 8/14/2025; B22625-09-3 8/14/2025; B22625-09-4 8/14/2025; B22625-09-5 8/14/2025; B22625-09-6 8/14/2025; B22625-09-7 8/14/2025; B22625-10-1 8/14/2025; B22625-10-2 8/14/2025; B22625-10-3 8/14/2025; B22625-10-4 8/14/2025; B22625-10-5 8/14/2025; B22625-10-6 8/14/2025; B22625-10-7 8/14/2025; B22625-10-8 8/14/2025; B22625-11-1 8/14/2025; B22625-11-2 8/14/2025; B22625-11-3 8/14/2025; B22625-11-4 8/14/2025; B22625-11-5 8/14/2025; B22625-11-6 8/14/2025; B22625-11-7 8/14/2025; B22625-11-8 8/14/2025; B22625-12-1 8/14/2025; B22625-12-2 8/14/2025; B22625-12-3 8/14/2025; B22625-12-4 8/14/2025; B22625-12-5 8/14/2025; B22625-12-6 8/14/2025; B22625-12-7 8/14/2025; B22625-12-8 8/14/2025; B22625-13-1 8/14/2025; B22625-13-2 8/14/2025; B22625-13-3 8/14/2025; B22625-13-4 8/14/2025; B22625-13-5 8/14/2025; B22625-13-6 8/14/2025; B22625-13-7 8/14/2025; B22625-13-8 8/14/2025; B22725-02-1 8/15/2025; B22725-02-2 8/15/2025; B22725-02-3 8/15/2025; B22725-02-4 8/15/2025; B22725-02-5 8/15/2025; B22725-02-6 8/15/2025; B22725-02-7 8/15/2025; B22725-02-8 8/15/2025; B22725-03-1 8/15/2025; B22725-03-2 8/15/2025; B22725-03-3 8/15/2025; B22725-03-4 8/15/2025; B22725-03-5 8/15/2025; B22725-03-6 8/15/2025; B22725-03-7 8/15/2025; B22725-03-8 8/15/2025; B22725-04-1 8/15/2025; B22725-04-2 8/15/2025; B22725-04-3 8/15/2025; B22725-04-4 8/15/2025; B22725-04-5 8/15/2025; B22725-04-6 8/15/2025; B22725-04-7 8/15/2025; B22725-04-8 8/15/2025; B22725-05-1 8/15/2025; B22725-05-2 8/15/2025; B22725-05-3 8/15/2025; B22725-05-4 8/15/2025; B22725-05-5 8/15/2025; B22725-05-6 8/15/2025; B22725-05-7 8/15/2025; B22725-05-8 8/15/2025; B22725-06-1 8/15/2025; B22725-06-2 8/15/2025; B22725-06-3 8/15/2025; B22725-06-4 8/15/2025; B22725-06-5 8/15/2025; B22725-06-6 8/15/2025; B22725-06-7 8/15/2025; B22725-06-8 8/15/2025; B22725-07-1 8/15/2025; B22725-07-2 8/15/2025; B22725-07-6 8/15/2025; B22725-07-7 8/15/2025; B22725-07-8 8/15/2025; B22725-08-1 8/15/2025; B22725-08-2 8/15/2025; B22725-08-3 8/15/2025; B22725-08-4 8/15/2025; B22725-08-5 8/15/2025; B22725-08-6 8/15/2025; B22725-08-7 8/15/2025; B22725-08-8 8/15/2025; B22725-09-1 8/15/2025; B22725-09-2 8/15/2025; B22725-09-3 8/15/2025; B22725-09-4 8/15/2025; B22725-09-5 8/15/2025; B22725-09-6 8/15/2025; B22725-09-7 8/15/2025; B22725-09-8 8/15/2025; B22825-01-1 8/16/2025; B22825-01-2 8/16/2025; B22825-01-3 8/16/2025; B22825-01-4 8/16/2025; B22825-01-5 8/16/2025; B22825-01-6 8/16/2025; B22825-01-7 8/16/2025; B22825-01-8 8/16/2025; B22825-02-1 8/16/2025; B22825-02-2 8/16/2025; B22825-02-3 8/16/2025; B22825-02-4 8/16/2025; B22825-02-5 8/16/2025; B22825-02-6 8/16/2025; B22825-02-7 8/16/2025; B22825-02-8 8/16/2025; B22825-03-1 8/16/2025; B22825-03-2 8/16/2025; B22825-03-3 8/16/2025; B22825-03-4 8/16/2025; B22825-03-5 8/16/2025; B22825-03-6 8/16/2025; B22825-03-7 8/16/2025; B22825-03-8 8/16/2025; B22825-04-1 8/16/2025; B22825-04-2 8/16/2025; B22825-04-3 8/16/2025; B22825-04-4 8/16/2025; B22825-04-5 8/16/2025; B22825-04-6 8/16/2025; B22825-04-7 8/16/2025; B22825-04-8 8/16/2025; B22825-05-1 8/16/2025; B22825-05-2 8/16/2025; B22825-05-3 8/16/2025; B22825-05-4 8/16/2025; B22825-05-5 8/16/2025; B22825-05-6 8/16/2025; B22825-05-7 8/16/2025; B22825-05-8 8/16/2025; B22825-06-1 8/16/2025; B22825-06-2 8/16/2025; B22825-06-3 8/16/2025; B22825-06-4 8/16/2025; B22825-06-5 8/16/2025; B22825-06-6 8/16/2025; B22825-06-7 8/16/2025; B22825-06-8 8/16/2025; B22825-07-1 8/… (truncated, 12153 characters total — see the official FDA record for the full value)
Recalling firm:
California Dairies Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

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FDA has not published a risk classification for this recall yet.

Recall #:
99007
Lot/product code:
Lot Code: UDI (01)00840311346288(0812)8.00 Software Version 8.00 The software error occurs if a customer generated an IOD for a toric implantation from April 13, 2026 to April 16, 2026 for multiple toric lens reservations for the same eye using the STAAR ICL Calculation Software.
Recalling firm:
Staar Surgical AG
View official FDA record (opens in a new tab)