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Recalls affecting Alaska

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

16,261 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

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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/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)

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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

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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.

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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/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

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

ALL 50 STATES
▸Full report

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

Recall #:
98786
Lot/product code:
GTIN 00643169454705, Lot Numbers: 0231823435, 0231961203; GTIN 20643169454709, Lot Numbers: 0231823435, 0231823478, 0231961203.
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

ALL 50 STATES
▸Full report

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

Recall #:
98786
Lot/product code:
GTIN 00643169454736, Lot Numbers: 0231650787, 0231758255, 0231862812, C231966207; GTIN 00673978188713, Lot Numbers: 0231937422; GTIN 20643169454730, Lot Numbers: 0231650787, 0231650793, 0231758250, 0231758255, 0231758279, 0231758282, 0231823523, 0231862812, 0231937422, C231965721, C231966207, C232428221, C232430086.
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU

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-09458-AH/10801902203172, 10801902193275, 10801902203172/33F24C0359, 33F24C1122, 33F24E0323, 33F24F0780, 33F24K0397, 33F25A0208, 33F25B0518, 33F25D0001, 33F25D0338, 33F25D0465, 33F25E0528, 33F25H0610, 33F25J0353, 33F25K0076, 33F25K0091, 33F25M0173, 33F26A1538, 33F26B0819, 33F24H0227; ASK-09458-COC/10801902193275, 10801902221084, 10801902216394/33F24K0755, 33F25C0380, 33F25D0590, 33F25H0583, 33F25J0354, 33F25K0125, 33F25M0243, 33F25M0393, 33F26A1535, 33F26B0404, 33F24F0732; ASK-09458-EUH/10801902193275, 10801902216394/33F24L0908, 33F25E0715, 33F25F0096, 33F25G0215, 33F25J0144, 33F25M0118, 33F26A1515, 33F26B0862, 33F24H0125; ASK-09458-SD/10801902193275, 10801902215014/33F25D0398, 33F25F0165, 33F25M0692, 33F26C0488; ASK-09458-VU/10801902217261, 10801902193275, 10801902217261, 10801902193275/33F24C0832, 33F24D0624, 33F24F0650, 33F24K0752, 33F24L0916, 33F25D0534, 33F25E0531, 33F25F0141, 33F25H0588, 33F25K0127, 33F25M0177, 33F26B0134, 33F26B0477, 33F26C0487, 33F24H0099
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: 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: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A; AGBA PI MIDLINE 1L: 4.5FR X 15CM/ASK-41541-VFHM; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPK; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKB; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKC; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPK; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKB; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKC; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPK; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPKB; PI MIDLINE 1L: 4FR X 20CM/CDC-32041-MPKC; PI MIDLINE 2-L: 5FR X 20CM/CDC-32052-MPKB; PI PICC NaviCurve: 1L 4FR x 55CM w BP/DLX-35541-CURVB; PI PICC: 1L 4FR x 55CM w Biopatch/DLX-35541-HPKB; PI PICC: 1L 4FR x 55CM w CHG/DLX-35541-HPKC; PI PICC: 2L 5FR x 55CM w Biopatch/DLX-35552-HPKB; PI PICC: 2L 5FR X 55CM w CHG/DLX-35552-HPKC; PI PICC: 3L 6FR x 55CM w Biopatch/DLX-35563-HPKB; AGBA PICC/DELTA KIT: 1L 4.5 FR X 40 CM/ASK-44041-NS; AGBA PICC/DELTA FG: 2L 5.5 FR X 40 CM/ASK-44052-NS; AGBA PICC/DELTA KIT: 1L 4.5 FR X 50 CM/ASK-45041-NS; PI PICC KIT: 2L 5.5 FR X 50 CM/ASK-45052-TG; PI AGBA PICC KIT: 3L 6 FR X 50 CM W/VPS/ASK-45063-NS; PICC KIT: 1L 4.5 FR X 55 CM CG+ VPS/ASK-45541-RH; AGBA PICC: 1L 4.5FR x 55CM w Teg CHG/DLX-45541-HPKC; AGBA PICC: 2L 5.5FR x 55CM w Teg CHG/DLX-45552-HPKC; AGBA PICC NaviCurve: 3L 6FR x 55CM TCG/DLX-45563-CURVC; AGBA PICC: 3L 6FR x 55CM w Biopatch/DLX-45563-HPKB; AGBA PICC: 3L 6FR x 55CM w Teg CHG/DLX-45563-HPKC; PI PICC KIT: 1-L 4 FR X 55 CM TIPTRACKER/CDC-35541-TTS; PI PICC NaviCurve: 1L 4FR x 55CM w CHG/DLX-35541-CURVC; PI PICC G4 Stylet: 1L 4FR x 55CM w BP/DLX-35541-VPSB; PI PICC NaviCurve: 2L 5FR x 55CM w CHG/DLX-35552-CURVC; PI PICC G4 Stylet: 2L 5FR x 55CM w BP/DLX-35552-VPSB; PI PICC G4 Stylet: 2L 5FR x 55CM w CHG/DLX-35552-VPSC; PI PICC NaviCurve: 3L 6FR x 55CM w CHG/DLX-35563-CURVC; PI PICC G4 Stylet: 3L 6FR x 55CM w CHG/DLX-35563-VPSC; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM/CDC-44041-VPS2; PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UWH1; PI AGBA PICC KIT: 2L 5.5FR X 55CM W/ VPS/ASK-45552-UWH1; AGBA PICC G4 Stylet: 1L 4.5FR x 55CM BP/DLX-45541-VPSB; ACCESS TRAY/ASK-04001-NWM; ACCESS TRAY/ASK-04001-VCUH3; PI PICC:1L 4FR X 40CM PRELOAD VPS STYLET/CDC-34041-VPS; PI PICC:2L 5FR X 50CM PRELOAD VPS STYLET/CDC-35052-VPS; ACCESS KIT/ASK-04001-BWK2; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU11; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PVD; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16CM/ASK-12703-LMDTG1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8IN/ASK-15703-ECMC4; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-15703-PNM; CVC KIT: 3 LUMEN 12 FR X 6IN/ASK-22123-UAB; 2-L CVC KIT: 4 FR X13 CM/CDC-24402-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-X1A; CVC KIT: 3L 7 FR X 16 CM/ASK-42703-CPR; CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-DMC2; CVC KIT: 2 LUMEN 8 FR X 8 IN (20 CM)/ASK-45802-PCMH1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-MM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHUMC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PSAU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-RHR1; PI CATHETER 2L: 8 FR X 16 CM AGB+/ASK-42802-DU1; PI CVC KIT: 2L 8 FR X 6 IN/ASK-42802-PHF4; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PHHN1; MULTILUMEN CVC KIT: 2L 8 FR X 6 IN/ASK-42802-POSU3; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/ASK-42802-PUCD1; MULTI-LUMEN CVC KIT:2-L 8FR X 6IN (16CM)/ASK-42802-PWHC1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UHC; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-MCY1; PI CVC KIT: 3L 7FR X 8IN (20 CM) AGB+/ASK-45703-BCH; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-EMC; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-MHMC1; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/ASK-45703-NWM; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCOR; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PIMH; MULTI LUMEN CVC KIT: 3L

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-02031-MK1A/10801902193275/33F25C0444; CDC-41541-MPK1A/10801902193275/33F24L1137; CDC-41552-MPK1A/10801902193275, 50801902130162/33F24L0382, 33F25A0315, 33F25B0630, 33F25K0421, 33S24B0571; ASK-41541-VFHM/10801902193275, 10801902218862/33F24L1080, 33F25B0475, 33F25C0351, 33F25D0404, 33F25E0556, 33F25E0784, 33F25F0186, 33F25J0218, 33F25K0077, 33F25K0100, 33F25M0182, 33F26A1549, 33F26B0823; CDC-41541-MPK/10801902193275, 10801902193275/33F25H0768, 33S23K0382; CDC-41541-MPKB/10801902193275, 10801902205411/33F24H0429, 33F24K0043, 33F24M0067, 33F24M0149, 33F25A0390, 33F25B0099, 33F25B0343, 33F25C0578, 33F25E0421, 33F25F0401, 33F25G0515, 33F25G0710, 33F25H0817, 33F25J1008, 33F25L0015, 33F25L0050, 33F25L0295, 33F25M0499, 33F26A0330, 33X25J0003; CDC-41541-MPKC/10801902205435, 10801902193275/33F24D0982, 33F24F0166, 33F24F0167, 33F24H0398, 33F24H0454, 33F24J0380, 33F24J0389, 33F24K0581, 33F24L0182, 33F24M0022, 33F24M0077, 33F25A0348, 33F25B0228, 33F25B0281, 33F25B0289, 33F25B0344, 33F25C0513, 33F25C0532, 33F25C0558, 33F25D0710, 33F25D0736, 33F25F0020, 33F25F0025, 33F25F0032, 33F25H0818, 33F25J0577, 33F25J0657, 33F25L0251, 33F25L0296, 33S25A0211, 33F26C0435; CDC-41552-MPK/10801902201505/33F24D0561, 33F26B0490, 33S24A0521; CDC-41552-MPKB/10801902193275, 10801902205428/33F24J0183, 33F24J0221, 33F24L0010, 33F24L0173, 33F24M0114, 33F25B0223, 33F25B0299, 33F25D0724, 33F25F0436, 33F25G0640, 33F25K0354, 33F25L0265, 33F26B1048; CDC-41552-MPKC/10801902205442, 10801902193275/33F24C0861, 33F24D0343, 33F24F0090, 33F24K0474, 33F25C0208, 33F25D0559, 33F25E0827, 33F25H0608, 33F25J0434, 33F25M0248, 33F26A1559, 33F26C0776; CDC-32041-MPK/10801902193275, 10801902201475/33F25C0701, 33F25H0613, 33F25J0433, 33F25L0115, 33F25M0250, 33F26B0436; CDC-32041-MPKB/10801902205398, 10801902193275/33F24D0854, 33F24F0897, 33F24L0952, 33F25B0502, 33F25D0512, 33F25E0825, 33F25G0327, 33F25J0327, 33F25M0210, 33F26B0434, 33S23E0870; CDC-32041-MPKC/10801902193275/33F25D0513, 33F25H0590, 33F26A1387; CDC-32052-MPKB/10801902205404, 10801902193275/33F24F0825, 33F24L0381, 33F25D0514, 33F25H0609; DLX-35541-CURVB/10801902193275, 10801902208757/33F25D0674, 33F25J0186, 33S23G0883, 33S23H0988; DLX-35541-HPKB/10801902193275/33F25D0129, 33F25E0708; DLX-35541-HPKC/10801902193275/33F25D0244, 33F25E0830; DLX-35552-HPKB/10801902193275/33F25D0246, 33F25D0518, 33F25F0149; DLX-35552-HPKC/10801902193275, 10801902216721/33F25D0247, 33F25D0519, 33F25H0460, 33S23K0380; DLX-35563-HPKB/10801902193275/33F25K0318; ASK-44041-NS/10801902193275, 10801902216462/33F24L0347, 33S23H0298; ASK-44052-NS/10801902193275, 10801902216455/33F25A0302, 33S23J0265; ASK-45041-NS/10801902216677/33S24A0529; ASK-45052-TG/10801902193275/33F24L0864, 33F25D0409, 33F25H0490, 33F26A1379; ASK-45063-NS/10801902193275/33F24L1002; ASK-45541-RH/10801902193275/33F25B0574, 33F25E0607, 33F25H0427, 33F25J0161, 33F26A1412; DLX-45541-HPKC/10801902208849, 10801902193275/33F24D0604, 33F25D0128, 33F25E0763, 33F25J0131, 33F25M0315, 33F26B0456; DLX-45552-HPKC/10801902208856, 10801902193275/33F24F0097, 33F25C0450, 33F25D0252, 33F25D0625, 33F25G0321, 33F25H0601, 33F26B0213; DLX-45563-CURVC/10801902193275, 10801902208740/33F25A0321, 33F25B0635, 33F25D0522, 33F25E0766, 33F25G0394, 33F26C0707; DLX-45563-HPKB/10801902193275/33F25D0384, 33F25F0226; DLX-45563-HPKC/10801902208863, 10801902193275/33F24D0184, 33F25B0698, 33F25E0661, 33F26A1545; CDC-35541-TTS/10801902193275/33F25B0468; DLX-35541-CURVC/10801902193275, 10801902216684/33F25D0574, 33F25E0759, 33F25G0216, 33F25H0591, 33F25M0200, 33F26B0192; DLX-35541-VPSB/10801902193275, 10801902208665/33F25C0212, 33F25D0378, 33F25E0831, 33F25F0101, 33F25G0364, 33F25J0128, 33F25J0256, 33F25K0193, 33F25M0164, 33F26A1131, 33F26B0180, 33F26C0699; DLX-35552-CURVC/10801902193275, 10801902216714/33F25C0373, 33F25D0619, 33F25F0222, 33S24C0282; DLX-35552-VPSB/10801902193275, 10801902208672/33F25B0536, 33F25D0248, 33F25D0379, 33F25D0575, 33F25H0471, 33F25H0603, 33F26C0042; DLX-35552-VPSC/10801902193275, 10801902216738/33F25B0389, 33F25D0249, 33F25J0122, 33F25J0335, 33F25M0445, 33F26A0470, 33S24B0733; DLX-35563-CURVC/10801902193275, 10801902216745/DLX-35563-CURVC, DLX-35563-CURVC, DLX-35563-CURVC; DLX-35563-VPSC/10801902193275, 10801902216769/33F25C0395, 33F26B0380; CDC-44041-VPS2/10801902193275, 50801902120699/33F24K0430, 33S23L0922; ASK-45541-UWH1/10801902193275, 10801902217216/33F24L0991, 33F25C0198, 33F25E0572, 33F25H0457, 33F25J0400, 33F25M0151, 33F26B0384; ASK-45552-UWH1/10801902193275/33F24L0431, 33F25B0576, 33F25G0212, 33F25H0589, 33F25J0225, 33F25M0229, 33F26A1554; DLX-45541-VPSB/10801902193275, 10801902208603/33F24L1122, 33F25B0679, 33F25D0064, 33F25D0521, 33F25H0403, 33F25H0605, 33F26C0119; ASK-04001-NWM/10801902193275, 10801902222715/33F25F0005, 33F25F0125, 33F26A1493, 33F26B0829; ASK-04001-VCUH3/10801902214895, 10801902193275/33F24D0895, 33F24F0785, 33F24L1087, 33F25B0172, 33F25F0161, 33F25G0221, 33F25H0522, 33F25… (truncated, 10348 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

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

ALL 50 STATES
▸Full report

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

Recall #:
98786
Lot/product code:
GTIN 20643169454815, Lot Numbers: 0231665658, C231786900.
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

ALL 50 STATES
▸Full report

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

Recall #:
98786
Lot/product code:
GTIN 00643169454521, Lot Numbers: 0231545565, C231958117; GTIN 20643169454525, Lot Numbers: 0231545557, 0231545560, 0231545565, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716, 0231667178, 0231823613, 0231823689, 0231823700, 0231846134, 0231862819, 0231912810, C231958117, C231958118, C231958119, C231958120, C232287623.
Recalling firm:
Medtronic Perfusion Systems
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

PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU

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-00376/10801902197938, 10801902193275, 10801902197938, 10801902197952/33F24D0004, 33F24E0166, 33F24G0318, 33F24J0486, 33F24K0083, 33F24L0725, 33F25A0453, 33F25A0610, 33F25C0749, 33F25C0906, 33F25E0031, 33F25G0075, 33F25H0007, 33F25H0719, 33F25J0739, 33F25J0817, 33F25L0462, 33F25M0954, 33F26B0949, 33F26C0575, 33F24A0016; ASK-00376-VCU/10801902193275, 10801902138788/33F24L0522, 33F24M0088, 33F25C0060, 33F25D0282, 33F25F0257, 33F25G0746, 33F25J0602, 33F24D0201
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

ALL 50 STATES
▸Full report

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

Recall #:
98786
Lot/product code:
GTIN 00673978188447, Lot Numbers: 0231651336; GTIN 20643169454877, Lot Numbers: 0231651336, 0231651345, 0231651385, 0231651389, 0231651396, 0231667029, 0231667046, 0231757975, 0231758248, 0231758259, 0231936467, 0231982226, 0232274424, C232287618, C232287619, C232287620, C232598550, C232598552.
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-YNH; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09907-SL; PSI KIT: 8.5 FR X 4-1/8IN (10 CM)/NA-09803-CDC; PSI KIT: 9 FR X 4-1/8IN (10 CM)/NA-09903-CDC; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL4; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-MGH3; MULTI-LUMEN/PSI KIT/AK-11142-SPCS; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/CDC-11242-1A; MULTI-LUMEN/PSI KIT/AK-11142-D; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-11142-MGH4; MULTI-LUMEN/PSI KIT/NA-11242-CDC; MULTI-LUMEN/PSI KIT/AK-21142-SK; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDTG; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-RH; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-IMC; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDTG; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMD; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UU3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-VCU; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-X1A; MULTI-LUMEN/PSI KIT/AK-21242-CDC; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH4; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-GH1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-SUU; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC4; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UKL; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMF; MULTILUMEN/PSI KIT: 9 FR X 4 1/2 IN/ASK-21242-UR1; PSI KIT: 8.5 FR/AK-29803-CDC; PSI KIT: 9 FR/AK-29903-CDC; PSI KIT: 9 FR/AK-29907-CDC; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-UN1; PSI KIT: 9 FR/ASK-09903-UM; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDT; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDTG; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-BID1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDTG; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UMD; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UR1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-X1A; PSI KIT: 8.5 FR X 10 CM/ASK-29803-ECL; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM3; PSI KIT: 9 FR X 10 CM/ASK-29903-ECL; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM3; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09907-TG1

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): GU-04020/30801902118807, 10801902193275, 30801902118807, 30801902118807/33F24C0753, 33F24E0736, 33F24G0154, 33F24G0648, 33F24H0377, 33F25A0059, 33F25A0072, 33F25A0395, 33F25F0260, 33F25G0736, 33F25H0298, 33F25J0603, 33F26B0084, 33F26B0314, 33F26C0578, 33F24D0036; AK-09803-CDC/20801902121756, 10801902193275, 10801902117417/33F24B0126, 33F24B0127, 33F24C0021, 33F24D0021, 33F24E0072, 33F24G0338, 33F24G0587, 33F24J0506, 33F24K0105, 33F24L0722, 33F25A0468, 33F25C0107, 33F25C0953, 33F25E0054, 33F25E0921, 33F25G0086, 33F25H0023, 33F25J0828, 33F25K0255, 33F25K0364, 33F25L0328, 33F24A0239; AK-09903-CDC/10801902117417, 10801902193275, 20801902121916/33F24A0356, 33F24B0128, 33F24B0129,33F24C0022, 33F24D0022, 33F24E0074, 33F24E0075, 33F24G0340, 33F24G0588, 33F24J0507, 33F24K0107, 33F24L0676, 33F24L0759, 33F25A0470, 33F25C0108, 33F25C0730, 33F25E0056, 33F25E0923, 33F25H0025, 33F25J0471, 33F25K0031, 33F25L0237, 33F25M0920, 33F26A1053, 33F24A0386; ASK-09810-PCMH1/10801902193275/33F25K0051, 33F24J0109; ASK-09903-KH/10801902119350, 10801902193275/33F24D0713, 33F24K0385, 33F24L1060, 33F25D0340, 33F25E0778, 33F25H0567, 33F25M0163, 33F26A1407, 33F25E1184; ASK-09903-PHP1/10801902193275, 10801902115222/33F24J0115, 33F25H0497, 33F26A0410, 33F24F0625; ASK-09903-UPA/10801902193275, 10801902118193/33F24K0387, 33F24L0855, 33F24A0787; ASK-09903-YNH/10801902118193, 10801902193275, 10801902118209/33F24E0527, 33F24H0478, 33F24L0682, 33F25H0135, 33F25J0915, 33F24A0110; ASK-09907-SL/10801902118209, 10801902193275/33F24D0053, 33F24D0967, 33F24G0265, 33F25E0215, 33F25E0454, 33F25G0680, 33F25J0551, 33F25K0328, 33F25L0206, 33F26C0312, 33F25B0188; NA-09803-CDC/10801902119930, 10801902193275, 10801902119947/33F24C0756, 33F24E0739, 33F25A0342, 33F25J0615, 33F26B0028, 33F24A1327; NA-09903-CDC/10801902119947, 10801902193275, 10801902119954/33F24E0740, 33F24H0381, 33F24J0199, 33F24J0361, 33F24L0020, 33F25B0278, 33F25C0551, 33F25E0340, 33F25E0400, 33F25E0468, 33F25F0419, 33F25H0708, 33F26A1655, 33F26B0023, 33F24A0113; ASK-09903-ECL4/10801902193275, 10801902224344/33F26A1582, 33F26B0399, 33F25E0534; ASK-09903-MGH3/10801902193275, 10801902189841, 10801902212006/33F25C0264, 33F25G0338, 33F25J0360, 33F25K0130, 33F26B0126, 33F26C0004, 33F24D0780; AK-11142-SPCS/10801902196412, 10801902193275, 60801902123093/33F24A0382, 33F24A1019, 33F24C0024, 33F24E0078, 33F24E0154, 33F24G0343, 33F24J0510, 33F24K0110, 33F24L0673, 33F25A0472, 33F25C0381, 33F25C0389, 33F25C0952, 33F25E0059, 33F25H0027, 33F25J0831, 33F25K0302, 33F25L0365, 33F26B0514, 33S24J0510, 33F24D0075; CDC-11242-1A/60801902116736, 10801902193275, 40801902111768/33F24D0431, 33F24E0213, 33F24F0140, 33F24F0220, 33F24G0103, 33F24H0392, 33F24H0425, 33F24H0450, 33F24L0011, 33F25B0018, 33F25B0096, 33F25D0705, 33F25E1120, 33F25F0024, 33F25F0414, 33F25G0043, 33F25G0486, 33F25J0016, 33F25J0992, 33F25K0308, 33F25M0481, 33F24C1001; AK-11142-D/20801902121916, 10801902193275, 10801902196412/33F24A1018, 33F24C0023,33F24E0077, 33F24G0342,33F24J0509, 33F24K0109, 33F24L0615, 33F25A0471, 33F25C0842, 33F25E0058, 33F25G0088, 33F25J0472, 33F25K0301, 33F25L0467, 33F26B0593, 33F26B0958, 33F24A0252; ASK-11142-MGH4/10801902193275, 10801902189865, 10801902182545/33F25D0466, 33F25F0113, 33F25L0130, 33F25M0398, 33F26A1539, 33F26B0680, 33F24D0736; NA-11242-CDC/10801902119954, 10801902193275, 10801902119978/33F24A0817, 33F24A1218, 33F24B0399, 33F24C0270, 33F24G0554, 33F24J0663, 33F24L0743, 33F25C0197, 33F25C0870, 33F25E0273, 33F25H0179, 33F25H0761, 33F25L0419, 33F26B0562, 33F24C0271; AK-21142-SK/10801902193275, 30801902122248, 30801902122255/33F24G0356, 33F24G0589, 33F24J0520, 33F24K0122, 33F24L0670, 33F25A0480, 33F25C0720, 33F25E0071, 33F25H0030, 33F25J0837, 33F25L0473, 33F25M0964, 33F26A1097, 33F26B0956, 33R24L0670, 33F24D0023; ASK-21142-LMDTG/10801902193275/33F25K0417, 33F25F0007; ASK-21142-RH/10801902193275/10801902129953/33F24J0108, 33F24L0165, 33F24M0172, 33F25B0422, 33F25E1172, 33F25H0776, 33F25K0424, 33F26C0337, 33F25A0245; ASK-21242-IMC/10801902193275, 10801902118407/33F24G0500, 33F24J0631, 33F24K0255, 33F24L0609, 33F25A0572, 33F25E0223, 33F25H0142, 33F25J0921, 33F26B0543, 33F25C0696; ASK-21242-LMDTG/10801902193275, 10801902220827/33F25G0202, 33F25H0414, 33F25K0382, 33F25M0130, 33F26C0378, 33F24H0123; ASK-21242-UMD/10801902193275/33F24K0476, 33F24L0315, 33F25B0196, 33F25C0279, 33F25D0476, 33F25H0492, 33F25J0378, 33F25M0150, 33F26A1365, 33F25B0551; ASK-21242-UU3/10801902193275/33F24G0503, 33F24L0652, 33F25C0181, 33F25E0226, 33F25H0144, 33F25J0556, 33F24K0077; ASK-21242-VCU/10801902193275, 10801902112962/33F24K0694, 33F25G0171, 33F25H0495, 33F25J0379, 33F26C0494, 33F25C0439; CDC-21242-1A/50801902116821, 10801902193275/33F24D0486, 33F24D0981, 33F24E0227, 33F24F0175, 33F24G0104, 33F24H0296, 33F24H0305, 33F24H0331, 33F24H0357, 33F24H0393, 33F24H0427, 33F24M0019, 33F24M0055, 33F25A0131, 33F25A0367, 33F25B0019, 33F25C0511, 33F25D0706, 33F25E0417, 33F25E1122, 33F25F0416, 33F25… (truncated, 8177 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: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC; ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC; RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC; RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV; ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1; ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS; RADIAL ARTERY KIT/ASK-04500-AH; RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S; ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA; ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2; ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS; ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S; ARTERIAL LINE KIT/HF-04510-1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1; RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH; RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A; RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1; CVC KIT: 20 GA X 12CM/ASK-04510-UCLA; ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1

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): NA-04220-1A/10801902193275/33F26B0027; NA-04220-X1A/10801902193275/33F24G0553, 33F25E0272, 33F25E1053, 33F25H0760, 33F25J0636; ASK-04018-HCA/10801902119268/33F24A0078; ASK-04018-UPM/50801902117644, 10801902193275/33F23B0953, 33F24A0389, 33F24B0140, 33F24D0028, 33F24H0480, 33F24J0550, 33F24K0164, 33F25A0505, 33F25C0742, 33F25C0792, 33F25E0961, 33F25E1070, 33F25E1071, 33F25E1072, 33F25G0105, 33F25H0062, 33F25J0866, 33F25L0353, 33F26B0507; ASK-04020-HC/10801902121384, 10801902193275/33F24A0828, 33F24B0246, 33F24C0148, 33F24D0113, 33F24G0409, 33F24J0559, 33F24K0172, 33F24L0693, 33F25C0136, 33F25C0933, 33F25E0128, 33F25H0070, 33F25L0356; ASK-04020-HMC/10801902117691, 10801902193275/33F24A0324, 33F24A0743, 33F24B0248, 33F24C0150, 33F24D0115, 33F24H0475, 33F24K0174, 33F24L0802, 33F25H0072, 33F25J0872, 33F25L0395, 33F26B0650, 33S24A0743, 33S24C0150, 33F26B0673; ASK-04020-MMC/10801902117769, 10801902193275/33F24C0160, 33F24D0123, 33F24E0423, 33F24G0420, 33F24H0487, 33F24J0571, 33F24K0183, 33F24L0692, 33F25A0523, 33F25C0974, 33F25E0139, 33F25H0081, 33F25J0880, 33F25L0346, 33F25M0853; ASK-04020-SV/10801902117837, 10801902117837/33F24A0868, 33F24B0269, 33F24E0436, 33F24E0437, 33F24L0746, 33F25H0087, 33F25J0885, 33F26B0512; ASK-04100-AMC-S1/10801902124927, 10801902193275/33F24D0139, 33F24E0446, 33F24G0439, 33F24K0199, 33F25A0532, 33F25E0153, 33F25G0116, 33F25H0093, 33F25J0516, 33F26B0656; ASK-04100-NS/10801902193275, 10801902117929/33F24G0440, 33F24L0579, 33F24M0266, 33F25A0533, 33F25C0151, 33F25C0788, 33F25E0155, 33F25H0095, 33F25J0518, 33F25K0256, 33F25L0448, 33F25M0945, 33F26B0649, 33F26B0667; ASK-04500-AH/10801902114041, 10801902193275/33F24A0153, 33F24A0803, 33F24B0282, 33F24C0181, 33F24E0452, 33F24G0444, 33F24J0586, 33F25A0538, 33F25H0101, 33F25J0893; ASK-04500-HF-S/10801902118001, 10801902193275/33F24A0141, 33F24A0753, 33F24A1157, 33F24B0283, 33F24C0182, 33F24D0143, 33F24E0453, 33F24G0445, 33F24J0587, 33F24K0206, 33F24L0766, 33F25C0154, 33F25C0966, 33F25E0161, 33F25H0102, 33F25J0894, 33F25L0492, 33R25C0966; ASK-04510-HA/10801902193275/33F24J0591, 33F24K0210, 33F25B0685, 33F25C0911, 33F25E0166, 33F25E0993, 33F25J0524, 33F25L0449; ASK-04510-HF/10801902193275, 10801902118025/33F24G0450, 33F24J0305, 33F24K0211, 33F24L0543, 33F24L0558, 33F25A0540, 33F25C0896, 33F25E0167, 33F25G0119, 33F25H0104, 33F25J0525, 33F25K0412, 33F25L0339, 33F26B0648, 33F26B0666, 33F26C0588; ASK-04510-IHC1/10801902193275/33F24J0306, 33F24L0699, 33F25C0157, 33F25C0782, 33F25E0168, 33F25H0105, 33F25L0475; ASK-04510-MSK2/10801902118049, 10801902193275/33F24A0872, 33F24B0290, 33F24D0150, 33F24E0461, 33F24G0453, 33F24J0594, 33F25A0541, 33F25C0852, 33F25E0170, 33F25H0740; ASK-04510-NS/10801902193275, 10801902224177/33F25K0324, 33F26B0653; FS-04510-S/10801902193275, 10801902119824/33F24L0738, 33F25C0188, 33F25C0755, 33F25L0426, 33F26B0657; HF-04510-1/10801902119855, 10801902193275/33F24D0036, 33F24G0537, 33F24J0652, 33F24L0576, 33F25A0593, 33F25C0897, 33F25E0260, 33F25E1044, 33F25H0166, 33F25J0936, 33F26B0652, 33F26B0675; ASK-04020-BSM/10801902193275/33F24J0365, 33F24M0075, 33F25A0079, 33F25B0312, 33F25D0116, 33F25D0297, 33F25E0367, 33F25F0400, 33F25G0653, 33F25J0983, 33F25L0155; ASK-04020-HH1/10801902193275, 10801902128536/33F24K0173, 33F24L0729, 33F25C0137, 33F25C0914, 33F25E0129, 33F25H0071, 33F25J0871, 33F25L0420, 33F26B0563; ASK-04020-JMH1/10801902114089, 10801902193275/33F24A0792, 33F24C0152, 33F24D0117, 33F24E0416, 33F24H0481, 33F24J0562, 33F24L0775, 33F25A0515, 33F25C0139, 33F25C0970, 33F25E0975, 33F25H0074, 33F25J0875, 33F25L0330, 33F26A0969; ASK-04020-MAS/10801902193275/33F25K0032; ASK-04020-MCC/10801902193275/33F24K0063, 33F24M0043; ASK-04020-MHT/10801902117721, 10801902193275/33F24A0094, 33F24B0019, 33F24D0052, 33F24D0966, 33F24J0475, 33F24L0083, 33F25C0739, 33F25E0980, 33F25F0529, 33F25J0506, 33F25K0329, 33F26A0403, 33F26C0056, 33F26C0260; ASK-04020-MI/10801902193275/33F24K0549, 33F25A0521, 33F25E1149, 33F25F0453, 33F25G0679, 33F25H0079, 33F25H0734, 33F25J0794, 33F25K0327, 33F25L0207, 33F25M0689, 33F26A0398; ASK-04020-MIHS/10801902193275/33F25A0442, 33F25B0233, 33F25C0379, 33F25D0035, 33F25H0494, 33F25K0426; ASK-04020-MUSC/10801902117776, 10801902193275/33F24A0751, 33F24A1138, 33F24B0259, 33F24C0162, 33F24D0125, 33F24E0425, 33F24G0421, 33F24K0184, 33F24L0640, 33F25C0141, 33F25C0830, 33F25E0140, 33F25H0083, 33F25J0881, 33F26B0575; ASK-04020-NCB/10801902117783, 10801902193275/33F24A0864, 33F24B0260, 33F24C0163, 33F24E0426, 33F24G0422, 33F24J0572, 33F24K0185, 33F24L0711, 33F25C0921, 33F25E0141, 33F25H0084, 33F25J0508, 33F25M0857; ASK-04020-PMC/30801902158896, 10801902193275/33F24F0095, 33F24L0242; ASK-04020-SPH/10801902193275/33F25C0143, 33F25C0977, 33F25E0985, 33F25H0735, 33F26A1075; ASK-04020-UPM/10801902117851, 10801902193275/33F24A0255, 33F24A0385, 33F24A1037, 33F24B0141, 33F24C0033, 33F24E0095, 33F24G0434, 33F24J0299, 33F24K0195, 33F24L0578, 33F25A0529, 33F25C0147, 33F25C08… (truncated, 5967 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

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

ALL 50 STATES
▸Full report

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

Recall #:
98786
Lot/product code:
GTIN 20643169454556, Lot Numbers: 0231881762, 0231881786, 0231931962, 0231962106, C233032040.
Recalling firm:
Medtronic Perfusion Systems
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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.

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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
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UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables

The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.

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

Recall #:
98833
Lot/product code:
Lot Code: Product Code: 1739994 UDI-DI: 00887761972780 Serial Numbers: 109931797, 109931798, 109931799, 109943588, 109943590, 109948550, 109964963, 109964964, 109964969, 109964970, 109964971, 109980700, and 110006694
Recalling firm:
Baxter Healthcare Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B

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): SAC-01218-B/10801902225303/33F26C0515; SAC-01218-C/10801902225273/33F26C0517; SAC-01618-B/10801902225310/33F26C0518
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: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH; SPINAL ANESTHESIA KIT/ASK-25090-BIDMC; SPINAL ANESTHESIA KIT/ASK-25090-UF

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): ASA-24090-SB/10801902193275, 10801902201994/33F24G0383, 33F24K0145, 33F24L0550, 33F25A0491, 33F25C0838, 33F25E0094, 33F25H0044, 33F25J0490, 33F25L0444, 33S25E0094; ASA-24103-SB/10801902202007, 10801902193275/33F24E0380, 33F24E0381, 33F24G0274, 33F24K0146, 33F24L0696, 33F25A0492, 33F25C0123, 33F25C0774, 33F25E0095, 33F25G0097, 33F25H0045, 33F25J0491, 33F25L0329, 33F26B0494; ASA-25090-SB/10801902202014, 10801902193275/33F24E0089, 33F24E0090, 33F24G0384, 33F24K0147, 33F24L0545, 33F24L0755, 33F25A0493, 33F25A0621, 33F25B0374, 33F25C0844, 33F25E0097, 33F25G0098, 33F25H0046, 33F25J0850, 33F25K0257; ASK-24090-SA/10801902202281, 10801902193275/33F24D0396, 33F24E0544, 33F24L0589, 33F25C0182, 33F25C0965, 33F25E0228, 33F25H0146, 33F25J0922, 33F26B0573; ASK-24090-SPH/10801902202274, 10801902193275/33F24D0397, 33F24G0505, 33F24K0260, 33F24L0654, 33F25A0575, 33F25C0943, 33F25E1026, 33F25H0753, 33F25K0410, 33F26B0501; ASK-25090-BIDMC/10801902210217/33F24E0546, 33F24E0547, 33F24L0636, 33F25C0183, 33F25C0831, 33F25E0230, 33F25J0923, 33F25L0357; ASK-25090-UF/10801902206692, 10801902193275/33F24E0548, 33F24L0602, 33F25C0806, 33F25E0231, 33F25G0138, 33F25J0557, 33F25M0957;
Recalling firm:
ARROW INTERNATIONAL, LLC
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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)
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

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

ALL 50 STATES
▸Full report

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

Recall #:
98786
Lot/product code:
GTIN 20643169454808, Lot Numbers: 0231859673.
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter

Certain lots of product have the potential for a sterile barrier breach.

ALL 50 STATES
▸Full report

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

Recall #:
98786
Lot/product code:
GTIN 20643169454785, Lot Numbers: 0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262, 0231772525, 0231792898, 0232066774, 0232112345, 0232114667, C232276641, C232277146, C232277149, C232949860, C232949864.
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPN1A; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A-U; LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XN1A

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-12123-PCDC/10801902193275, 10801902168471/33F24J0419, 33F25B0015, 33F25F0022, 33F25G0482, 33F25J0029, 33F25K0268, 33F26B0056, 33F24E0175; AK-15123-PCDC/10801902186499, 10801902193275, 10801902168532/33F24G0140, 33F24J0449, 33F24M0074, 33F25B0040, 33F25J0604, 33F24A0767; CDC-15123-XP1A/10801902193275, 30801902111822, 10801902213430/33F25D0438, 33F25E0649, 33F25H0579, 33F25J0313, 33F26B0161, 33F26C0198, 33F24D0355; CDC-16123-XP1A/10801902193275, 40801902111867/33F25D0612, 33F25G0291, 33F25H0578, 33F26C0190, 33F24L0469; CDC-16123-XPN1A/10801902193275, 10801902196498/33F25J0113, 33F24D0974; CDC-25122-XN1A-U/10801902193275/33F25J0114, 33F25B0621; CDC-22123-XN1A/50801902123515/33F24D0928
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: ACCESS TRAY/ASK-04001-MC3

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-04001-MC3/
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 12 FR X 16 CM/AK-12122-F

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-12122-F/10801902197129, 10801902193275, 10801902197129, 10801902168464/33F24B0184, 33F24D0076, 33F24F0321, 33F24G0345, 33F24K0111, 33F25A0474, 33F25C0915, 33F25E0061, 33F25E0924, 33F25J0832, 33F25L0404, 33F26B0552, 33F24A0102
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)