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Recalls affecting Alabama

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

16,873 recalls found

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

▸Full report
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/virusAnnounced 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

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced 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

View FDA’s announcement (opens in a new tab)
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)

▸Full report
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)
UnclassifiedAllergenUndeclaredAnnounced 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/virusAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
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/virusAnnounced 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)
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UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU

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-07155-MGU/10801902210217/33F25C0798
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: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5; CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH; CATH S-L 20 GA X 5 CM HYDROPHILIC/ASK-00520-UHC; ARTERIAL LINE KIT: 20 GA x 5IN/ASK-00820-CL; RA CATH KIT: 20 GA X 8 CM X 12 CM/ASK-00820-WC; ARTERIAL CATHETERIZATION KIT/ASK-01218-HM; SAC KIT: 20 GA X 12CM/ASK-01220-HMH; ARTERIAL CATH KIT: 20GA X 12CM/ASK-01220-NWM; ARTERIAL CATH KIT: 20 GA X 12 CM/ASK-01220-UH; ARTERIAL CATH: 18 GA X 6 1/2IN/ASK-01618-AU; RA CATH KIT: 18 GA X 6 IN/ASK-01618-CL; ARTERIAL CATH KIT: 18 GA X 6 1/2 IN/ASK-01618-JH; ARTERIAL CATHETERIZATION KIT/ASK-01618-PH; ARTERIAL CATH KIT: 18 GA X 6 1/2IN/ASK-01618-RU; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HF; ARTERIAL CATH KIT: 18 GA X 6 IN (16 CM)/ASK-04018-NS; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-ST; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04120-BGH; ART/VESS CATH KIT:20GAX4.45CM/20GAX12CM/ASK-04500-SM; ARTERIAL LINE KIT/ASK-04500-UCH; ARTERIAL LINE KIT/ASK-04510-EUH2; ARTERIAL LINE KIT: 20GA X 5IN (12CM)/ASK-04510-MS4; ARTERIAL LINE KIT/ASK-04510-UPM; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-1A; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-X1A; ARTERIAL CATH KIT: 22GA X 5CM/SAC-00522-1A ARTERIAL CATH KIT: 22 GA X 5CM/SAC-00522-X1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-X1A; SAC KIT: 18 GA X 12CM/SAC-01218-1A; SAC KIT: 18 GA X 12CM/SAC-01218-X1A; SAC KIT: 20 GA X 12CM/SAC-01220-1A; SAC KIT: 20 GA X 12CM/SAC-01220-X1A; SAC KIT: 18 GA X 16CM/SAC-01618-1A; SAC KIT: 18 GA X 16CM/SAC-01618-X1A; ACCESS TRAY/UM-04018; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-ABM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-BGH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LOL; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MHS; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-MIB3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC1; RA CATH SET: 20 GA X 1 3/4 IN/ASK-04020-URMC; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04220-FMH1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-1A; RA CATH KIT: 20 GA X 4.45 CM W BIO/NA-04020-B; RA CATH KIT: 20 GA X 4.45 CM W CHG/NA-04020-C; VESSEL CATH KIT: 20 GA X 5IN (12 CM)/ASK-04550-NYP; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04300-PHP1; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04301-TJ; ARTERIAL ACCESS KIT/ASK-04001-VAMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-WBH

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-04020-SPC/10801902121551, 10801902193275/33F23M0171, 33F24C0729, 33F24E0699, 33F24G0596, 33F24H0057, 33F24J0350, 33F24J0458, 33F24K0615, 33F24M0126, 33F25A0338, 33F25B0039, 33F25B0131, 33F25D0192, 33F25D0281, 33F25E1109, 33F25F0496, 33F25J0764, 33F26B0054; ASK-04020-MW/10801902142983, 10801902193275/33F23M0188, 33F24B0447, 33F24C0744, 33F24E0725, 33F24G0231, 33F24G0669, 33F24H0344, 33F24L0005, 33F24L0024, 33F25A0062, 33F25B0064, 33F25D0290, 33F25D0729, 33F25E0428, 33F25H0328, 33F26B0089, 33F26B0263; ASK-04510-MM5/10801902193275/33F24K0360, 33F25A0237, 33F25B0546; ASK-00520-JH/10801902138788, 10801902193275/33F24D0201, 33F24F0686, 33F24J0128, 33F24K0373, 33F25A0204, 33F25B0541, 33F25D0324, 33F25D0645, 33F25H0429, 33F25H0507, 33F25J0195, 33F26A1380, 33F26B0159, 33F26C0192; ASK-00520-UHC/10801902139839, 10801902193275/33F23L0771, 33F24A0775, 33F24B0219, 33F24C0125, 33F24D0093, 33F24E0383, 33F24G0386, 33F24J0284, 33F24K0149, 33F24L0712, 33F25A0495, 33F25C0125, 33F25C0826, 33F25E0099, 33F25H0047, 33F25J0851, 33F25L0392, 33F26B0540; ASK-00820-CL/10801902193275, 10801902193916/33F24G0275, 33F24J0285, 33F24K0152, 33F24L0590, 33F25A0497, 33F25C0797, 33F25E0102, 33F25H0050, 33F25J0853, 33F25L0385, 33F26B0536; ASK-00820-WC/10801902193275/33F24G0150, 33F24G0227, 33F24G0691, 33F24H0253, 33F24K0624, 33F25B0091, 33F25B0334, 33F25J0574, 33F26B0113; ASK-01218-HM/10801902193275/33F24G0276, 33F24K0551, 33F24L0215, 33F25A0296, 33F25B0543, 33F25E0450, 33F25F0364, 33F25G0163, 33F25G0208, 33F25H0499, 33F25J0100, 33F25J0139; ASK-01220-HMH/10801902193275/33F25B0245, 33F25B0544, 33F25C0698, 33F25D0388; ASK-01220-NWM/10801902193275/33F24H0181, 33F24J0154, 33F24K0497, 33F25F0157, 33F25H0658; ASK-01220-UH/10801902193275/33F24G0391, 33F24J0286, 33F24J0541, 33F24K0154, 33F24L0663, 33F25C0126, 33F25E0104, 33F25E0955, 33F25H0052, 33F25J0494, 33F25J0855, 33F25L0459, 33F25M0952; ASK-01618-AU/10801902205909, 10801902193275/33F24F0213, 33F24K0673, 33F25C0653, 33F25E1171, 33F25L0062, 33F26A0233; ASK-01618-CL/10801902195934, 10801902193275/33F24E0648, 33F24K0355, 33F25A0224,33F25B0493, 33F25D0327, 33F25E0588, 33F25F0158, 33F25J0140, 33F25M0112, 33F26C0366; ASK-01618-JH/10801902138801, 10801902193275/33F24D0584, 33F24K0490, 33F24L0844, 33F25B0494, 33F25D0530, 33F25H0834, 33F25K0264, 33F25K0357, 33S25D0530; ASK-01618-PH/10801902193275/33F24K0749, 33F24L0837, 33F25C0251, 33F25E0019, 33F25G0220; ASK-01618-RU/10801902202304, 10801902193275/33F24B0869, 33F24D1027, 33F25A0102, 33F25C0713, 33F25J0792, 33F25M0618; ASK-04018-HF/10801902193275/33F24H0156, 33F24L0397, 33F25D0391, 33F25G0401, 33F25K0069, 33F25M0142; ASK-04018-NS/10801902193275/33F25E1176, 33F25G0103; ASK-04018-ST/10801902117639, 10801902193275/33F24A0112, 33F24A0826, 33F24B0237, 33F24C0140, 33F24E0402, 33F24E0403, 33F24G0281, 33F24K0163, 33F25A0504, 33F25C0780, 33F25E0115, 33F25G0104, 33F25J0498, 33F25M0917, 33F26B1011; ASK-04120-BGH/10801902117936, 10801902193275/33F24D0518, 33F24G0262, 33F24J0474, 33F25A0150, 33F25C0740, 33F25E1207, 33F25H0096, 33F25K0331; ASK-04500-SM/30801902118012, 10801902193275/33F24A0117, 33F24A1163, 33F24D0059, 33F24D0968, 33F24E0782, 33F24G0263, 33F24J0302, 33F25C0500, 33F25E0162, 33F25H0738, 33F25L0209, 33F25M0617, 33F26B0020, 33F26B0746; ASK-04500-UCH/10801902139464, 10801902193275/33F24E0454, 33F24G0446, 33F24J0588, 33F24K0207, 33F24L0715, 33F25C0155, 33F25C0924, 33F25E0163, 33F25H0739, 33F25L0332, 33F26B0655; ASK-04510-EUH2/10801902193275, 10801902213386/33F24J0303, 33F24L0728, 33F25C0156, 33F25C0803, 33F25E0164, 33F25H0103, 33F25J0522, 33F25L0343, 33F25M0850, 33F26B0660; ASK-04510-MS4/10801902193275, 10801902139709/33F24K0212, 33F24L0764, 33F25C0860, 33F25E0169, 33F25E0994, 33F25J0526, 33F25L0423, 33F26B0654; ASK-04510-UPM/10801902118087, 10801902193275/33F24B0144, 33F24E0101, 33F24E0102, 33F24G0456, 33F24J0595, 33F24K0216, 33F24L0675, 33F25A0544, 33F25C0947, 33F25E0174, 33F25H0107, 33F25J0529, 33F25J0738, 33F25L0022, 33F26B0647, 33F26B0665, 33F26C0617; SAC-00520-1A/10801902140644, 10801902193275/33F24C0780, 33F24E0772, 33F24G0025, 33F24G0675, 33F24H0061, 33F24J0190, 33F24J0207, 33F24J0415, 33F24M0010, 33F25A0097, 33F25B0052, 33F25B0126, 33F25B0410, 33F25C0540, 33F25D0185, 33F25E0408, 33F25E0472, 33F25G0530, 33F25H0832, 33F25J0045, 33F25J1013, 33F25M0704, 33F26B0259; SAC-00520-X1A/10801902193275, 10801902140583/33F24J0208, 33F25A0098, 33F25B0023, 33F25B0127, 33F25B0287, 33F25D0086, 33F25E1180, 33F25F0288, 33F25F0425, 33F25H0347, 33F25H0866, 33F25L0177, 33F26B0058, 33F26B0279; SAC-00522-1A/10801902140606, 10801902193275/33F23L0976, 33F24B0461, 33F24C0783, 33F24E0775, 33F24G0243, 33F24J0242, 33F24J0416, 33F24M0122, 33F25A0389, 33F25B0076, 33F25E0382, 33F25H0348, 33F26B0257; SAC-00522-X1A/10801902193275/33F24L0536, 33F26B0059; SAC-00820-1A/10801902140637, 10801902193275/33F24B0463, 33F24C0785, 33F24E0777, 33F24F0081, 33F24G0136, 33F24H0059, 33F24H0352, 33F24H0388, 33F24L0057, 33F24M0011, 33F24M0123,… (truncated, 9582 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 PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT: 1L 4.5FR 40CM/CDC-44041-HPK1A; AGBA PI PICC KIT 2-LUMEN: 5.5 FR X 40CM/CDC-44052-HPK1A; AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM/CDC-44052-VPS2; PI AGBA PICC KIT: 3-L 6 FR X 50 CM/CDC-45063-HPK1A; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM/CDC-45541-VPS2; AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM/CDC-45552-VPS2; PICC/VPS 1L 4.5 FR/ASK-45541-CHS; PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI2; PICC KIT: 2L 5.5FR 55CM AGBA VPS/ASK-45552-CHS; PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI2; PICC KIT: 3L 6FR 55CM AGBA/ASK-45563-CHS; PI JACC KIT: 3L 6 FR X 25 CM CG+/ASK-42563-LTAC; PI JACC KIT: 1-L 4.5 FR X 25 CM CG+/CDC-42541-JX1A; PI JACC KIT: 2-L 5.5 FR X 25 CM CG+/CDC-42552-JX1A; PI JACC KIT: 3-L 6 FR X 25 CM CG+/CDC-42563-JX1A; PI JACC KIT: 2-L 5.5 FR X 30 CM CG+/CDC-43052-JX1A; PI JACC KIT: 3-LUMEN: 6 FR X 30 CM CG+/CDC-43063-JX1A; PICC KIT: 2-L 4 FR X 55 CM/CDC-05542-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): DLX-35563-HPKC/10801902193275/33F25D0520; ASK-44552-ABKB/10801902140798, 10801902216677/33X25K0002, 33S24A0529; ASK-45552-MHBV/10801902193275/33F25K0372, 33F25M0199, 33F26A1534, 33F24L0348; DLX-45541-HPKB/10801902193275, 10801902208849/33F25G0393, 33F25L0055, 33F26A1570, 33F24D0604; ASK-45052-MC/10801902216660/33S24A1242; CDC-44041-HPK1A/10801902193275/33F24K0430; CDC-44052-HPK1A/10801902193275/33F25D0241; CDC-44052-VPS2/10801902193275/33F25E0514; CDC-45063-HPK1A/10801902193275/33F25D0242; CDC-45541-VPS2/50801902120781, 10801902193275/33S24A0211, 33F25C0699; CDC-45552-VPS2/10801902193275/33F25E0704; ASK-45541-CHS/10801902193275/33F26A1422, 33F24L0897; ASK-45541-UOI2/10801902193275/33F24L0991; ASK-45552-CHS/10801902193275/33F26A1395, 33F25G0260; ASK-45552-UOI2/10801902193275/33F24L0431; ASK-45563-CHS/10801902193275/33F25A0199; ASK-42563-LTAC/10801902203271/33F24F0852; CDC-42541-JX1A/10801902193275/33F26A1469, 33F24J0135; CDC-42552-JX1A/10801902193275/33F25D0561, 33F24L0285; CDC-42563-JX1A/10801902193275, 10801902170863/33F25C0702, 33F25D0562, 33F25G0311, 33F25J0437, 33F24D0507; CDC-43052-JX1A/10801902193275/33F25M0062, 33F24J0120; CDC-43063-JX1A/10801902193275, 10801902188332/33F25G0003, 33F26B0805, 33F25D0240; CDC-05542-PK1A/10801902193275, 50801902116715/33F25H0436, 33F25H0576, 33F24D0325
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: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000

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-09000/30801902121722, 10801902193275, 20801902121756/33F24B0178, 33F24C0097, 33F24E0336, 33F24F0311, 33F24G0335, 33F24K0101, 33F24L0795, 33F25E0919, 33F25G0467, 33F25G0758, 33F25H0722, 33F25J0468, 33F25L0463, 33F26A0389, 33F24A0368
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.

ALL 50 STATES
▸Full report

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

Recall #:
98917
Lot/product code:
Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124
Recalling firm:
GE Medical Systems China Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS, PNEUMOTHORAX KIT/AK-01500, PNEUMOTHORAX KIT (NO HEIMLICH VALVE)/ASK-01500, PNEUMOTHORAX KIT/ASK-01500-JCM

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-01600/50801902120156, 10801902193275, 50801902120156, 60801902120160/33F24A0376, 33F24A1008, 33F24C0091, 33F24D0067, 33F24E0321, 33F24G0322, 33F24L0062, 33F24L0811, 33F24M0267, 33F25C0101, 33F25C0988, 33F25E0035, 33F25H0010, 33F25J0819, 33F26B0492, 33F24A0044; AK-01601/60801902120160, 10801902193275, 10801902190915/33F24A0783, 33F24A1070, 33F24C0092, 33F24E0322, 33F24G0323, 33F24J0273, 33F24L0651, 33F25C0102, 33F25C0916, 33F25E0036, 33F25G0078, 33F25J0460, 33F25L0371, 33F24B0427; ASK-01601-MM/10801902125726, 10801902193275, 10801902125726, 10801902205909/33F24F0656, 33F24K0319, 33F24M0166, 33F25A0163, 33F25E0587, 33F25G0164, 33F25L0116, 33F26A1377, 33F26C0174, 33F24F0213; AK-01000-T/10801902145120, 10801902193275, 10801902194029/33F24C0090, 33F24D0066, 33F24E0319, 33F24G0320, 33F24K0085, 33F24L0792, 33F25C0872, 33F25E0033, 33F25J0459, 33F25L0367, 33F24A0015; AK-01000/10801902197952, 10801902193275, 10801902197952, 10801902145120/33F24A0017, 33F24A0018, 33F24A0348, 33F24A0349, 33F24A0350, 33F24A0351, 33F24A1005, 33F24A1006, 33F24D0005, 33F24D0006, 33F24D0007, 33F24D0008, 33F24D0009, 33F24D0010, 33F24D0011, 33F24D0012, 33F24E0032, 33F24E0033, 33F24E0034, 33F24E0035, 33F24E0036, 33F24E0037, 33F24E0038, 33F24E0041, 33F24E0042, 33F24E0167, 33F24E0168, 33F24E0169, 33F24E0170, 33F24E0171, 33F24G0319, 33F24G0567, 33F24G0568, 33F24J0487, 33F24J0673, 33F24K0084, 33F24K0308, 33F24K0312, 33F24L0626, 33F24L0726, 33F24L0782, 33F24L0787, 33F25A0454, 33F25A0611, 33F25A0612, 33F25C0100,33F25C0211,33F25C0905,33F25C0954, 33F25E0032,33F25E0286, 33F25E0287, 33F25E0908, 33F25E1063, 33F25E1064, 33F25G0076, 33F25G0157, 33F25H0008, 33F25H0188, 33F25H0189, 33F25H0190, 33F25H0191, 33F25H0192, 33F25J0458, 33F25J0740, 33F25J0741, 33F25J0788, 33F25J0799, 33F25J0800, 33F25K0250, 33F25K0251, 33F25K0360, 33F25K0361, 33F25K0362, 33F25K0363, 33F25L0019, 33F25L0020, 33F25L0100, 33F25L0101, 33F25L0268, 33F25L0485, 33F25L0487, 33F25M0831, 33F25M0860, 33F26A0217, 33F26A0218, 33F26A0693, 33F26A0988, 33F26B0505, 33F26B0506, 33F26C0574, 33F24A0794; ASK-01000-CHP/10801902193275, 30801902120190, 10801902203134/33F24G0228, 33F24J0192, 33F24K0020, 33F24L0021, 33F24L0523, 33F24M0063, 33F25B0010, 33F25B0061, 33F25B0132, 33F25C0405, 33F25D0198, 33F25H0277, 33F25H0810, 33F25J0995, 33F26A1273, 33F26B0695, 33F24E0388; ASK-01000-NW/10801902193275, 10801902114867/33F24G0390, 33F24K0153, 33F25B0693, 33F25C0873, 33F25H0051, 33F25J0854, 33F25M0921, 33F24A0645; ASK-01000-UPMS/10801902114867, 10801902193275/33F24B0805, 33F24C0930, 33F24D0683, 33F24H0186, 33F24L0214, 33F24L0912, 33F25B0542, 33F25D0325, 33F25D0527, 33F25F0156,33F25J0099, 33F25J0196, 33F25L0270, 33F26A1392, 33F24G0276; AK-01500/10801902194029, 10801902193275, 50801902120156/33F24E0044, 33F24E0172, 33F24E0173, 33F24G0321, 33F24G0569, 33F24J0488, 33F24K0086, 33F24K0573, 33F24L0724, 33F25A0455, 33F25C0722, 33F25D0126, 33F25E0034, 33F25E0909, 33F25G0077, 33F25G0549, 33F25H0009, 33F25H0720, 33F25J0818, 33F25L0384, 33F26B0535, 33F26C0263, 33R24E0044, 33F23K0711; ASK-01500/10801902156232, 10801902193275, 30801902120206/33F24A0777, 33F24C0130, 33F24E0391, 33F24G0392, 33F24J0542, 33F24L0765, 33F25C0127, 33F25C0735, 33F25E0105, 33F25H0053, 33F25J0495, 33F25L0335, 33F24A1274; ASK-01500-JCM/30801902120206, 10801902193275, 10801902125726
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: PARACENTESIS KIT/ASK-00376-JHH

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-00376-JHH/10801902193275/33F25G0629, 33F24K0592
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: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711

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-04210/10801902121582, 10801902193275/33F24A1009, 33F24B0106, 33F24C0009, 33F24D0014, 33F24G0324, 33F24J0490, 33F24K0089, 33F24L0671, 33F25A0456, 33F25C0899, 33F25E0037, 33F25H0011, 33F25J0461; AK-04300/10801902121636, 10801902193275/33F24A1257, 33F24B0435, 33F24C0734, 33F24E0704, 33F24F0011, 33F24G0224, 33F24G0684, 33F24H0373, 33F24M0148, 33F25A0364, 33F25B0084, 33F25D0193, 33F25D0693, 33F25E0479, 33F25H0686, 33F25J0587, 33F25J0651, 33F26C0397; CK-04711/20801902118787, 10801902193275/33F24A0137, 33F24A1212, 33F24B0382, 33F24C0255, 33F24E0572, 33F24G0531, 33F24J0648, 33F24L0731, 33F25A0590, 33F25C0979, 33F25E1039, 33F25J0622, 33F26B0640
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 21, 2026

Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01

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-0491-2026
Lot/product code:
Lot#: 9T21, Exp Date: 4/30/2026; Lot# 1U63, 2U47, Exp Date: 5/31/2026; Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027; Lot# 9V55, 8V58, 9V39, 9V97, Exp Date: 2/28/2027; Lot# 1W39, 1W40, Exp Date: 3/31/2027; Lot# 1X76, Exp Date: 4/30/2027.
Recalling firm:
Alcon Research 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 IHigh risk
FoodBacteria/virusRecalled 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)
Class IHigh risk
FoodBacteria/virusRecalled 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

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.

ALL 50 STATES
▸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

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.

ALL 50 STATES
▸Full report

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)
Class IHigh risk
FoodBacteria/virusRecalled 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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▸Full report

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

Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 / D150LC-40 / D150LC-40E/D150BC-41 / D150VC-41 / D150LC-41; Digital Radiography System RADspeed safire: UD150B-40 / D150BC-40; Radiography System RADspeed fit: N/A (Integrated in the system); X-RAY R/F SYSTEM SONIALVISION safire17:UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION safire Plus: UD150B-40 / D150BC-4;0 X-RAY R/F SYSTEM SONIALVISION safire: UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION VERSA: UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM FLUOROspeed 300:UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM SONIALVISION G4:D150BC-40S; X-RAY R/F SYSTEM FLUOROspeed X1:D150BC-40S

Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.

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

Recall #:
98571
Lot/product code:
System Serial Numbers:SMS20080542 SMS20120038 SMS20140084 SMS20090038 SMSMA110013 SMS20090239 SMS20080581 SMS20090099 SMS20110202 SMS2010011 SMS20080609 SMS20100127 SMS20090157 SMS20080573 SMS20100230 SMSMA130031 SMS20105020 SMS20080009 SMS20080174 SMS20090316 SMS20090281 SMSMA100027 SMSHP100002 SMSHP100001 SMS20100007 SMSHP100013 SMS20100068 SMS20100010 SMSBL110013 SMSMA120007 SMSNO130066 SMSHP110014 SMSMA130015 SMSPR130007 SMSBL120003 SMSMA110022 SMSNO120020 SMS20130105 SMS20160046 SMSVZ160014 SMS20080264 SMS20170160 SMS20160049 SMS20080358 SMS20080519 SMS20080238 SMS20080135 SMS20080493 SMS20090134 SMS20085122 SMS20070007 SMS20070013 SMS20095174 SMS20080128 SMS20210210 SMS20080283 SMS20080284 SMS20080154 SMS20170211 SMS20080091 SMSHP110015 SMS20090136 SMS20120069 SMS20120023 SMSMA140083 SMS20140060 SMS20080332 SMS20080277 SMS20170376 SMSNO120066 SMS20160121 SMS20090086 SMS20080018 SMS20100098 SMS20100041 SMSBL110001 SMSMA130023 SMSHP130022 SMS20110205 SMS20170164 SMS20180266 SMS20170272 SMS20090054 SMS20060032 SMS20210085 SMS20080133 SMS20080155 SMS20110213 SMS20095208 SMSHP120011 SMS2012008 SMS20120094 SMS20120106 SMS20120107 SMSHP140009 SMSMA150070 SMS20140064 SMS20190264 SMS20100205 SMS20080189 SMS20100205 SMS20080190 SMS20070002 SMS20080162 SMS20100221 SMS20120011 SMS20110186 SMS20140003 SMS20090053 SMS20110139 SMS20095169 SMS20080247 SMS20090154 SMS20090039 SMSHP110007 SMS20200064 SMS20095200 SMS20080061 SMS20090188 SMS20090208 SMSVA090012 SMS20100114 SMS20100126 SMS20090214 SMS20090043 SMSMA110069 SMS20080156 SMS20190259 SMS20080109 SMS20070008 SMS20070001 SMS20210059 SMS20210193 SMS20210278 SMS20210392 SMS20210347 SMS20220070 SMS20220036 SMS20200068 SMS20200330 SMS20220168 SMS20220206 SMS20220299 SMS20220292 SMS20220323 SMS20220360 SMS20230010 SMS20230040 SMS20230071 SMS20230080 SMS20230092 SMS20230180 SMS20230194 SMS20230195 SMS20230217 SMS20230265 SMS20230277 SMS20240004 SMS20240006 SMS20240120 SMS20240206 SMS20200072 SMS20220262 SMS20220264 SMS20230014 SMS20230084 SMS20230121 SMS20230282 SMS20240053 SMS20240205 SMS20240251 SMS20210019 SMS20210171 SMS20210256 SMS20220050 SMS20210360 SMS20220054 SMS20220161 SMS20200100 SMS20200362 SMS20220286 SMS20220378 SMS20230145 SMS20230238 SMS20240055 SMS20240133 SMS20240163 SMS20240201 SMS20240203 SMS20210098 SMS20210170 SMS20220029 SMS20200061 SMS20200201 SMS20210272 SMS20220342 SMS20230019 SMS20230104 SMS20230158 SMS20240097 SMS20240105 SMS20240252 SMS20210400 SMS20230138 SMS20200017 SMS20210013 SMS20220281 SMS20220375 SMS20230275 SMS20220271 SMS20230306 SMS20240221 SMS20200020 SMS20230260 SMS20200099 SMS20220063 SMS20230132 SMS20230130 SMS20230312 SMS20220120 SMS20220159 SMS20200284 SMS20220243 SMS20230237 SMS20230273 SMS20230146 SMS20110211 SMSMA140017 SMS20150007 SMS20150048 SMS20110007 SMS20110108 SMS20080168 SMS20085070 SMS20085070 SMS20100072 SMS20110069 SMS20110070 SMS20080197 SMS20100071 SMS20090176 SMS20090274 SMS20100073 SMS20090275 SMS20080571 SMS20110179 SMSHP130015 SMSMA140028 SMSMA120031 SMSNO160044 SMS20150050 SMSMA130066 SMSMA130067 SMSNO140057 SMSMA130065 SMS20140058 SMSMA150033 SMSMA140048 SMSMA160006 SMSNO160008 SMSMA130053 SMSMA130068 SMSNO140002 SMS20080570 SMSMA130032 SMS20080196 SMS20130034 SMS20080300 SMS20060011 SMS20060012 SMS20080060 SMSMA160065 SMS20200029 SMSNO150091 SMSHP100003 SMS20100094 SMS20110025 SMS20090094 SMS20090095 SMS20090272 SMSHP100004 SMSBL100011 SMSHP100026 SMS20080545 SMS20100055 SMS20090080 SMS20100067 SMS20100160 SMS20100152 SMS20100175 SMS20100215 SMSBL100010 SMSBL110004 SMS20100009 SMSHP090003 SMSBL110005 SMS20090221 SMS20110067 SMS20090220 SMS20090156 SMS20080546 SMSHP090010 SMSBL100004 SMSBL100017 SMSBL100005 SMS20110137 SMSHP100023 SMS20090263 SMS20090181 SMS20100022 SMS20100056 SMSBL100013 SMS20090269 SMS20100179 SMSBL100012 SMS20090270 SMS20100035 SMS20090235 SMS20130106 SMSFD110024 SMSMA130005 SMS20130001 SMS20110170 SMS20120002 SMSHP130001 SMSNO120095 SMSMA130016 SMSMA120020 SMSNO140008 SMSHP120012 SMSFD130001 SMSFD130004 SMSFD130005 SMSMA130029 SMSMA130026 SMSNO120042 SMSBL110036 SMSHP110034 SMS20120113 SMS20120078 SMS20160095 SMSVA110008 SMSMA110018 SMSBL120008 SMS20110183 SMSNO120040 SMSBL110007 SMS20150061 SMSBL110008 SMS20150062 SMSBL110009 SMSBL110028 SMS20110204 SMS20150075 SMS20120115 SMSNO120064 SMSBL110026 SMS20150129 SMSNO120067 SMSBL110022 SMSNO120074 SMSNO110005 SMS20130006 SMSBL110006 SMSNO120068 SMSPR150001 SMSBL110020 SMSNO110009 SMSBL110019 SMS20120001 SMSBL110025 SMSNO150007 SMSMA130002 SMS20150021 SMSNO120092 SMSNO120009 SMS20110126 SMSNO130005 SMSBL110027 SMSNO120004 SMSNO120033 SMSNO150003 SMSNO140032 SMSNO150006 SMSMA150006 SMSNO150011 SMSNO150012 SMSNO150042 SMSMA140029 SMSMA140038 SMSNO140038 SMSHP140010 SMSHP140011 SMS20140074 SMSMA140042 SMS20140067 SMSNO140049 SMSMA140055 SMSMA140054 SMSNO140053 SMS20140015 SMSNO150085 SMS20140104 SMS20150123 SMSMA140080 SMSMA150104 SMSNO150084 SMSHP160003 SMSMA160038 SMSMA160041 SMS20160157 SMS20100201 SMS20110215 SMS20110216 SMSMA110071 … (truncated, 71920 characters total — see the official FDA record for the full value)
Recalling firm:
Shimadzu Medical Systems
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)
Class IIModerate risk
DrugRecalled April 20, 2026

Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.

Not guaranteed to be germ-free

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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-0499-2026
Lot/product code:
Lot#: 8T98, 9T31, 9T32, Exp. Date: 30/04/26; 2V13, 2V14, 2V15, Exp. Date 30/06/26; 3V35, Exp. Date 31/08/26;3V36, 3V37, Exp. Date 30/09/26; 5V45, 5V46, 9V12, Exp. Date 31/03/27; 1X57, 1X70, 1X84, Exp. Date 31/05/27.
Recalling firm:
SCOPE HEALTH
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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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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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)
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

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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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)
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)