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Recalls affecting South Carolina

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

16,870 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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UnclassifiedAnnounced September 3, 2026

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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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)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

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

Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDT1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDTG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PVH; 1L CVC KIT: 16 GA X 8 IN (20CM)/ASK-24301-JHH1; CVC KIT: 16 GA X 16 CM/CDC-24306-1A; CVC KIT: 3-L 7 FR X 30 CM ANTIMICROBIAL/CDC-24703-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-ACH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-BJC1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-DU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-EMC; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-LMDT1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-LMDTG1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-MCY1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-NS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAGP1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM)/ASK-42703-PAM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAMC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAU1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16/ASK-42703-PB1; PI CVC KIT: 3L 7 FR X 16CM AGB+/ASK-42703-PBSWH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 IN/ASK-42703-PCAM1; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-PCSJ2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PECL2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PGM4; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHHN1; MULTI LUMEN CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PLC; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMEM; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMHC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-POHU2; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU2; MULTILUMEN CVC KIT 7 FR X 6 IN (16 CM)/ASK-42703-PTJH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUCH2; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-PUCI1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUHC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUMH; MULTI-LUMEN PI CVC KIT: 3-L 7 FR/ASK-42703-PUPM1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-SHUF2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-SL1; CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-42703-UMC; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-WHH; CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-CHM; CVC KIT: 2L 8 FR X 16 CM/ASK-42802-LMDT1; PI CATHETER 2L: 8FR X 16CM AGB+/ASK-42802-MCY1; PI CVC KIT: 2L 8FR X 16CM AGB+/ASK-42802-PBSWH2; MULTILUMEN CVC KIT: 2L 8 FR X 6/ASK-42802-POSU2; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUNCC2; PI CVC KIT: 2-L 8 FR/ASK-42802-PUPM1; PI CVC KIT: 2L 8 FR/ASK-42802-TGH1; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-BJC1; CVC KIT: 4L 8.5 FR X (16CM) AGB+/ASK-42854-PBMH; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-PMM; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-PUCH2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-ACH; 3L CVC KIT: 7 FR X 20 CM AGB+/ASK-45703-ARM; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BJC1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BLH; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-DU1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-HHC4; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDT1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDTG1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-MCY1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NO; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NS1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PADV1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PAGP1; MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAMC1; MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAU1; PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PBSWH2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PCAM1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCSJ2; PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PDM1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PECL2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/A

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-JHH/10801902193275/33F24K0748, 33F26A1669, 33F25G0558; ASK-04001-LMDTG/10801902193275, 10801902218442/33F26A0405, 33F24E0333; ASK-12703-PSPH1/10801902214338, 10801902193275, 10801902214338/33F24F0787, 33F24L0304, 33F25A0242, 33F25C0268, 33F25D0470, 33F25E0537, 33F25E0854, 33F25J0365, 33F25M0247, 33F26A1555, 33F26B0855, 33F26C0742, 33F24K0672; ASK-12703-WMC2/10801902193275/33F24K0493, 33F24L0305, 33F25B0156, 33F25E0593, 33F25H0483, 33F25J0367, 33F25M0218, 33F24K0545; ASK-15703-LMDT1/10801902193275/33F24J0164, 33F24L0307, 33F25B0192, 33F25C0230; ASK-15703-LMDTG1/10801902193275/33F25D0537, 33F25E0670, 33F25G0295, 33F25J0146, 33F25K0093, 33F25M0138, 33F26B0131, 33F25E0312; ASK-15703-PVH/10801902133226, 10801902193275, 10801902210217/33F24D0809, 33F24F0669, 33F24K0462, 33F24L0226, 33F25A0167, 33F25B0193, 33F25B0547, 33F25D0265, 33F25D0653, 33F25G0169, 33F25G0404, 33F25J0369, 33F26A1459, 33F24M0270; ASK-24301-JHH1/10801902193275, 10801902214819, 10801902210217/33F25A0170, 33F25B0552, 33F25E0547, 33F25G0222, 33F25L0056, 33F26B0421, 33F24E0546; CDC-24306-1A/30801902116919, 10801902193275, 30801902116919/33F24D0786, 33F24E0620, 33F24F0926, 33F24K0446, 33F24L0990, 33F25A0310, 33F25D0495, 33F25E0880, 33F25J0323, 33F26B0377, 33F26C0693, 33F24L1111; CDC-24703-X1A/10801902193275/33F25D0497, 33F25E0748, 33F25G0318, 33F25H0570, 33F25J0325, 33F26A1563, 33F25B0619; CDC-25123-1A/10801902193275, 10801902191622/33F24H0012, 33F24L0481, 33F25C0445, 33F25D0500, 33F25F0382, 33F25G0258, 33F26A1560, 33F26B0394, 33F25B0675; ASK-42802-ECL3/10801902193275/33F25E0567, 33F25F0128, 33F25H0464, 33F25J0286, 33F26A1399; ASK-42703-ACH/10801902193275, 30801902119514/33F24L0327, 33F24L1064, 33F25C0292, 33F25E0675, 33F25H0420, 33F25J0267, 33F25L0122, 33F25M0091, 33F26A1505, 33F24D0032; ASK-42703-BJC1/10801902193275, 10801902202519/33F24K0500, 33F24L0328, 33F25B0556, 33F25G0173, 33F25J0268, 33F26A1513, 33F26B0767, 33F25C0744; ASK-42703-DU1/10801902193275, 1080190216099/33F25B0141, 33F25C0232, 33F25E0786, 33F25J0105, 33F25M0014, 33F26C0342, 33F24F0060; ASK-42703-EMC/10801902160475, 10801902118421/33F24F0881, 33F25A0214, 33F25C0293, 33F25D0596, 33F25H0632, 33F25M0115, 33F26C0343, 33F24F0132; ASK-42703-LMDT1/10801902205657, 10801902193275/33F24F0688, 33F24J0157, 33F24L0228, 33F24L0329, 33F24L1096, 33F25A0252, 33F25B0557, 33F25C0352, 33F25E0557, 33F25E0722, 33F25G0400, 33F25K0139, 33F26A1370, 33F26B0210, 33F25C0294; ASK-42703-LMDTG1/10801902193275, 10801902205695, 10801902220896/33F25E0558, 33F25E0860, 33F25G0271, 33F25G0399, 33F25H0419, 33F26B0387, 33F24G0070; ASK-42703-MCY1/10801902193275, 0801902220896/33F24H0198, 33F24K0425, 33F25A0198, 33F25B0651, 33F25C0353, 33F25D0405, 33F25E0676, 33F25H0452, 33F25J0220, 33F25M0183, 33F26A1479, 33F26B0863, 33F25H0409; ASK-42703-NS1/10801902193275, 10801902216479/33F25A0300, 33F25B0652, 33F25C0375, 33F25E0723, 33F25H0459, 33F25J0221, 33F26A1579, 33F26B0825, 33F25C0354; ASK-42703-PAGP1/10801902193275, 10801902158717, 10801902136685/33F25D0406, 33F25E0560, 33F25E0790, 33F25H0560, 33F25L0114, 33F26A1353, 33F26A1506, 33F26B0751, 33F24D0181; ASK-42703-PAM1/10801902136685, 10801902193275/33F24E0310, 33F24L0895, 33F25A0256, 33F25B0496, 33F25C0477; ASK-42703-PAMC2/10801902193275, 10801902217131/33F25F0188, 33F25J0270, 33F26C0161, 33F24K0400; ASK-42703-PAU1/10801902193275/33F24L0414, 33F25B0143, 33F25C0474, 33F25G0397, 33F25M0313, 33F26A1349, 33F25B0232; ASK-42703-PB1/10801902193275, 10801902220377/33F25E0458, 33F25K0427, 33F24F0065; ASK-42703-PBSWH2/10801902220377, 10801902193275, 10801902220377, 10801902203189/33F24F0651, 33F24K0368, 33F24L0230, 33F24L0415, 33F24L1079, 33F25B0167, 33F25C0440, 33F25D0539, 33F25E0014, 33F25E0596, 33F25G0205, 33F25H0511, 33F25J0222, 33F25K0112, 33F25M0394, 33F26B0412, 33F24D0720; ASK-42703-PCAM1/10801902203189, 10801902193275, 10801902141030/33F24F0675, 33F24L1058, 33F25B0560, 33F25C0355, 33F25D0351, 33F25E0725, 33F25G0366, 33F25J0386, 33F25M0388, 33F26B0791, 33F24F0874; ASK-42703-PCSJ2/10801902193275, 10801902211672/33F25H0468, 33F25J0271, 33F26B0389, 33F26C0179, 33S24L0906, 33F25B0445; ASK-42703-PECL2/10801902193275/33F25H0466, 33F25J0272, 33F26A0011; ASK-42703-PGM4/10801902193275, 10801902221824/33F25B0653, 33F25D0541, 33F25J0106, 33F25J0387, 33F25K0140, 33F26B0749, 33F26C0027, 33F25E1195; ASK-42703-PHHN1/10801902193275, 10801902144734/33F25H0486, 33F25K0064, 33F25M0673, 33F26A0249, 33F26B0906, 33F25E0009; ASK-42703-PLC/10801902193275/33F25D0407, 33F25E0791, 33F25F0099, 33F25H0606, 33F26A1393, 33F25E1196; ASK-42703-PMEM/10801902193275, 10801902142167/33F25G0554, 33F25K0054, 33F25L0256, 33F26C0050, 33F24L0418; ASK-42703-PMHC1/10801902193275/10801902135244/33F25E0561, 33F25H0430, 33F25H0638, 33F25J0388, 33F25M0232, 33F26B0135, 33F26B0796, 33F25F0363; ASK-42703-PNHS1/10801902193275, 10801902225495/33F25D0542, 33F25E0599, 33F25H0498, 33F25H0650, 33F26D0066; ASK-42703-POHU2/10801902193275, 10801902212020/33F25E056… (truncated, 25622 characters total — see the official FDA record for the full value)
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: PACING/PSI KIT: 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

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

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: 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)
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

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM, AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1, AHDC KIT: 3-L 12 FR X 20 CM/ASK-15123-UPM, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-P1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XP1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPCN1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-P1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPCN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPN1A, AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPCN1A, HEMODIALYSIS KIT 2L: 12 FR X 20CM AGB/AK-25122-CDC, HEMODIALYSIS KIT: 2-LUMEN 14 FR X 20 CM/AK-25142-F, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM1, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM2, AHDC KIT: 2L 14 FR X 15 CM/ASK-22142-UOC1, AHDC AGB KIT: 2-L 14 FR X 15 CM/ASK-22142-UPM, HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UNC1, AHDC KIT: 2L 14 FR X 20 CM/ASK-25142-UOC1, AHDC AGB KIT: 2L 14 FR X 20 CM/ASK-25142-UPM, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/ASK-26142-UNC1, HEMODIALYSIS KIT: 2LUMEN 12 FR X 16 CM/AU-22122-F, HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A-U, HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB/CDC-22142-1A, HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-XC1A, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A-C, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XCN1A-U, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XN1A-U, HEMODIALYSIS KIT: 2L 12 FR X 13 CM AGB/CDC-23122-XU1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-X1A, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-XU1A, HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/CDC-25142-1A, HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB/CDC-25142-XC1A, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A-C, HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XCN1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XN1A, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/CDC-26142-1A, HEMODIALYSIS KIT: 2L 14 FR X 25 CM AGB/CDC-26142-X1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XCN1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XN1A, HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-25122-F, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 20 CM/CDC-25123-XCN1A, LBCVC AGB KIT:3-L 12 FR X 20 CM/CDC-25123-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-15122-F/10801902197136, 10801902193275, 10801902168525/33F24E0348, 33F24J0280, 33F24K0119, 33F24L0601, 33F25A0477, 33F25C0908, 33F24A0850; ASK-12123-UOC1/10801902193275/33F25B0430, 33F25D0119; ASK-12123-UPM/10801902193275, 10801902222463/33F25E0535, 33F25G0188, 33F25G0189, 33F26C0333, 33F25D0262; ASK-15123-UOC1/10801902193275/33F25C0378, 33F25D0121; ASK-15123-UPM/10801902193275, 10801902159950/33F25E0718, 33F25H0447, 33F26A1389, 33F24E0649; CDC-12123-P1A/40801902111768, 10801902193275/33F24D0632, 33F24F0758, 33F24L0465, 33F25A0281, 33F25E0794; CDC-12123-XP1A/10801902193275, 30801902111785, 10801902213416/33F25J0723, 33F26A1382, 33F26B0433, 36F25A0007, 36F25B0009, 36F25E0018, 33F24D0299; CDC-12123-XPCN1A/10801902213416, 10801902193275/33F24D0950, 33F24K0417, 33F24L0466, 33F25A0216, 33F25B0667, 33F25D0436, 33F25D0666, 33F25E0693, 33F25G0239, 33F25J0247, 33F26A1556, 33F26B0801, 33F26C0767, 33F25B0668; CDC-12123-XPN1A/10801902193275, 10801902213409/33F25D0554, 33F25G0240, 33F25J0312, 33F26B0214,33F26C0199, 33F25A0181; CDC-15123-P1A/10801902193275/33F25D0437, 33F25H0547,33F25B0613; CDC-15123-XPCN1A/10801902213430, 10801902193275/33F24F0107, 33F24F0998, 33F24K0403, 33F24L0834, 33F25A0283, 33F25B0527, 33F25E0650, 33F25E0745, 33F25F0085, 33F25H0596, 33F25J0314, 33F26A1464, 33F26B0883, 33F25B0669; CDC-15123-XPN1A/0801902193275, 10801902213423, 10801902116793/33F25D0439, 33F25G0238, 33F25H0597, 33F25J0315, 33F26A1468, 33F26B0826, 33F24C0461; CDC-16123-XPCN1A/10801902193275/33F25B0671, 33F25D0440, 33F25E0651, 33F25G0236, 33F25H0529, 33F25J0316, 33F25G0237, AK-25122-CDC/10801902193275/33F24G0370, 33F24K0135, 33F25C0120, 33F25C0969, 33F25E0942, 33F24G0371; AK-25142-F/10801902193275, 70801902123205, 10801902167795/33F25C0863, 33F25E0087, 33F25H0038, 33F25J0846, 33F26B0531, 33F24D0089; ASK-22122-MM1/10801902193275/33F25E0546; ASK-22122-MM2/10801902193275, 10801902221923, 10801902144956/33F25G0172, 33F25L0031, 33F25M0310, 33F26A1652, 33F26B0151, 33F26B0450, 33F24F0854; ASK-22142-UOC1/10801902193275/33F25C0545, 33F25D0122; ASK-22142-UPM/10801902193275, 10801902222487, 10801902202281/33F25D0594, 33F25F0116, 33F25G0187, 33F26A1390, 33F26B0205, 33F24D0396; ASK-25142-UNC1/10801902193275/33F25C0655, 33F24K0561; ASK-25142-UOC1/10801902193275/33F25B0362, 33F25D0123; ASK-25142-UPM/10801902193275/33F25E0595, 33F25H0446, 33F25J0381, 33F26A1446, 33F25J0092; ASK-26142-UNC1/10801902193275/33F25B0427, 33F25K0058; AU-22122-F/10801902193275/33F24K0269, 33F25A0584, 33F25C0862, 33F25E0245, 33F25J0567; CDC-22122-1A/20801902123484, 10801902193275/, CDC-22122-XCN1A-U/33F24F0996, 33F24L0374, 33F25C0461; CDC-22122-XN1A/10801902193275/33F25C0239, 33F25E0875, 33F25J0419; CDC-22122-XN1A-U/10801902193275, 10801902213621/33F25A0309, 33F25E0876, 33F26B0217; CDC-22142-1A/50801902123515, 10801902193275/33F24D0928, 33F24F0103, 33F24F0896, 33F24L0111, 33F24L0955, 33F25B0500, 33F25D0447, 33F25E0654, 33F25G0278, 33F25H0577, 33F25J0319; CDC-22142-XC1A/10801902193275/33F25A0284, 33F25J0180; CDC-22142-XCN1A/10801902193275, 10801902213539/33F25A0285, 33F25B0529, 33F25D0449, 33F25E0655, 33F25E0818, 33F25F0214, 33F25G0233, 33F26A1477, 33F26B0898, 33R25J0455; CDC-22142-XCN1A-C/10801902193275/33F24L0473, 33F25B0615, 33F25F0213; CDC-22142-XN1A/10801902193275, 10801902213522/33F25C0240, 33F25E0578, 33F25F0215, 33F25H0528, 33F25J0321, 33F26A1383, 33F26B0215, 33F26C0016; CDC-22142-XN1A-C/10801902193275/33F25B0485, 33F25E0879; CDC-23122-XCN1A-U/10801902193275/33F24L0279, 33F25D0492; CDC-23122-XN1A-U/10801902193275/33F25E0579; CDC-23122-XU1A/10801902193275/33F25D0493, 33F25H0432, 33F25J0248; CDC-25122-1A/10801902193275/33F25B0619, 33F25E0881; CDC-25122-X1A/10801902193275/33F25E0882, 33F25J0422; CDC-25122-XCN1A/10801902213492, 10801902193275/33F24F0929, 33F25C0242, 33F25D0498, 33F25E0883, 33F25G0234, 33F26B0439, 33F26C0214; CDC-25122-XCN1A-U/10801902193275/33F24L1041, 33F25B0620, 33F25F0121, 33F25G0226; CDC-25122-XN1A/10801902193275, 10801902213485/33F25C0243, 33F25E0884, 33F25K0183, 33R25E0884; CDC-25122-XU1A/10801902193275/33F25B0621, 33F25E0886, 33F25H0568; CDC-25142-1A/50801902123584, 10801902193275/33F24F0837, 33F24K0457, 33F24L0113, 33F24L1031, 33F25B0622, 33F25D0503, 33F25E0889, 33F25F0106, 33F25J0127; CDC-25142-XC1A/10801902193275/33F25B0467; CDC-25142-XCN1A/10801902193275, 10801902213553/33F25A0312, 33F25E0657, 33F25E0821, 33F25G0231, 33F25H0527, 33F25J0428, 33F26B0452, 33F26C0133; CDC-25142-XCN1A-C/10801902193275/33F24L0377, 33F25D0238; CDC-25142-XN1A/10801902193275, 10801902213546/33F25B0624, 33F25D0504, 33F25E0823, 33F25G0232, 33F26B0437; CDC-25142-XN1A-C/10801902193275/33F24L0485, 33F25B0676; CDC-26122-1A/60801902123611, 10801902193275/33F24F0084, 33F24K0475, 33F25G0389; CDC-26122-XCN1A/10801902213515, 10801902193275/33F24F1028, 33F24L0117, 33F25D0308, 33F25D0557, 33F25F0219; CDC-26122-XN1A/10801902193275/33F25E0451; CDC-26142-1A/10801902193275/33F24L0488, 33F24L1025, 33F25C… (truncated, 5791 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: 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

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; 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 00643169454460, Lot Numbers: 0231665646; GTIN 20643169454464, Lot Numbers: 0231665646, 0231665648.
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

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

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

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.

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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): 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
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UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA PI JACC KIT: 1-L 4.5 FR X 20 CM/CDC-42041-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 20 CM/CDC-42052-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 20 CM/CDC-42063-JX1A

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-41552-LTAC/10801902193275/33F24J0142, 33F24H0002; ASK-42063-LTAC/10801902214925/33F24F1005; CDC-41541-JX1A/10801902193275/33F25H0768; CDC-41552-JX1A/10801902193275, 10801902201505/33F25A0185, 33F25E0826, 33F24D0561; CDC-41563-JX1A/10801902193275/33F25B0150; CDC-42041-JX1A/10801902193275, 10801902188288/33F25E0751, 33F26C0353, 33F25A0186; CDC-42052-JX1A/10801902193275/33F25G0312, 33F24J0131; CDC-42063-JX1A/10801902193275/33F25C0447, 33F25D0516, 33F25E0752, 33F25J0436, 33F25C0370
Recalling firm:
ARROW INTERNATIONAL, LLC
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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.

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▸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

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.

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▸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
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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
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UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310

A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.

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▸Full report

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

Recall #:
98942
Lot/product code:
REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
Recalling firm:
PFM MEDICAL INC.
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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.

ALL 50 STATES
▸Full report

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

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

ALL 50 STATES
▸Full report

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

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

Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4; PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-CMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU4; PSI KIT: 9 FR X 4 1/8 IN (10CM)/ASK-09903-PCMH1; PSI KIT: 8.5 FR X 10 CM/CDC-09803-1A; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-PHP2; MULTI LUMEN/PSI KIT/ASK-11142-NSU; MULTI-LUMEN/PSI KIT/AK-21242-X; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-DMC; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC1; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-HF5; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDT; 2L MAC KIT: 9 FR DISTAL X 4IN (10 CM)/ASK-21142-UCL1; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-SL1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMH; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UN1; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XN1A; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-CO1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH3; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-OHSU3; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-SG2; MULTILUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-UOI1; 2 LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-WHC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-BID1; AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-BSWH2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-DU1; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-PCMH1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UCH2; AGB MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UHC2; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-BSWH2; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-HHC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-MCY1; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM1; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-VCU; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-MCY1; PSI KIT: 9 FR/ASK-29903-MHI; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-OHU4; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UCH2; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UCL1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UHC4; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29907-LGH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-X1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XCN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-AHH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XN1A; PSI ACCESS TRAY/ASK-04001-MM2; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC; MULTI LUMEN/PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU3

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-UMH/10801902193275, 10801902139365, 10801902143874/33F24M0171, 33F25A0444, 33F25G0008, 33F25K0039, 33F25L0133, 33F26B0369, 33F23K0811; ASK-09803-OSU4/10801902212075, 10801902193275/33F24F0994, 33F24K0428, 33F25B0183, 33F25D0761; ASK-09903-AMC1/1080190219327, 10801902161830, 10801902136678/33F25A0437, 33F25E0024, 33F25G0690, 33F25L0142, 33F26C0117, 33F24B0612; ASK-09903-CMC1/10801902136678, 10801902193275/33F24D0050, 33F24D0965, 33F24F0130, 33F24J0321, 33F24J0627, 33F24L0585, 33F25A0110, 33F25C0176, 33F25C0588, 33F25E0212, 33F25E1020, 33F25F0324, 33F25G0753, 33F25L0208, 33F26A0396, 33F26A1255, 33F25E0716; ASK-09903-OSU4/10801902212006, 10801902193275/33F24G0022, 33F24L0298, 33F25D0762; ASK-09903-PCMH1/10801902193275, 20801902115205/33F25L0139, 33F26B0136, 33F24H0108; CDC-09803-1A/50801902116715, 10801902193275, 60801902116729/33F24D0892, 33F24F0766, 33F24L0274, 33F25B0147, 33F25C0497, 33F25C0498, 33F25D0553, 33F25E0647, 33F25F0209, 33F25H0574, 33F25L0121, 33F25M0410, 33F24D0504; ASK-09903-ECL3/10801902193275/33F25G0241, 33F25H0530, 33F25J0357, 33F26A0015; ASK-11242-PHP2/10801902193275, 10801902196436/33F24J0117, 33F24K0727, 33F25A0009, 33F25E0003, 33F25F0359, 33F25K0040, 33F25L0132, 33F26B0223, 33F26D0016, 33F24K0544; ASK-11142-NSU/10801902182545, 10801902193275/33F24E0326, 33F24K0354, 33F24L0244, 33F24L0300, 33F25B0189, 33F25C0228, 33F25D0467, 33F25E0591, 33F25G0272, 33F25G0405, 33F25H0629, 33F25J0363, 33F26A1572, 33F26B0816, 33F24L0840; AK-21242-X/10801902193275, 30801902122262, 80801902123127/33F24G0358, 33F24J0522, 33F24K0124, 33F24L0749, 33F25B0683, 33F25E0073, 33F25J0479, 33F25L0443, 33F26C0301, 33F24D0371; ASK-21142-DMC/10801902193275, 10801902218930, 10801902206685/33F25B0242, 33F25M0671, 33F26A0237, 33F26B0946, 33F24D0718; ASK-21142-GMC1/10801902193275, 10801902200492/33F25B0642, 33F25E0719, 33F25H0582, 33F25M0147, 33F26C0335, 33F24F0098; ASK-21142-HF5/10801902200492, 10801902193275, 10801902200492/33F24F0921, 33F24K0350, 33F24L0245, 33F25A0168, 33F25C0272, 33F25D0344, 33F25F0103, 33F25G0282, 33F25H0614, 33F25J0371, 33F26A1525, 33F26C0040, 33F24L0309; ASK-21142-LMDT/10801902193275, 10801902220728/33F25A0041, 33F25B0381, 33F25D0346, 33F25F0172, 33F25K0416, 33F25M0343, 33F26B0189, 33F26C0139, 33F25K0206; ASK-21142-UCL1/10801902193275/33F25E0541, 33F25G0391, 33F25J0102, 33F25J0373, 33F25M0235, 33F26A1375, 33F24H0098; ASK-21142-UPMC2/10801902159479, 10801902193275, 10801902225365/33F24F0879, 33F24J0161, 33F24L0310, 33F24L1023, 33F25C0276, 33F25E0780, 33F25G0348, 33F25J0209, 33F26A1371, 33F26A1547, 33R25G0348, 33F26C0490; ASK-21242-SL1/10801902193275/33F26A1347, 33F25E0314; ASK-21242-UMH/10801902129502, 10801902193275, 10801902156348/33F24E0637, 33F24F0895, 33F24L0317, 33F25B0197, 33F25C0280, 33F25D0478, 33F25F0178, 33F25H0564, 33F25L0106, 33F26A1517, 33F24F0618; ASK-21242-UN1/10801902193275, 10801902156348/33F24H0146, 33F25A0438, 33F25D0032, 33F25E0315, 33F25F0236, 33F25H0778, 33F25K0044, 33F26A0252, 33F26B0219, 33F26C0048, 33F25C0816; CDC-21142-XCN1A/10801902196498, 10801902193275/33F24E0226, 33F24E0242, 33F24E0254, 33F24F0250, 33F24G0203, 33F24H0356, 33F24H0391, 33F24J0220, 33F24L0078, 33F24M0018, 33F24M0054, 33F24M0206, 33F25A0130, 33F25A0385, 33F25B0068, 33F25B0340, 33F25C0076, 33F25C0510, 33F25D0697, 33F25D0733, 33F25E1092, 33F25E1101, 33F25F0435, 33F25G0027, 33F25H0334, 33F25H0814, 33F25J1006, 33F25K0310, 33F25L0090, 33F25L0277, 33F26A1615, 33F26A1622, 33F26A1623, 33F26A1645, 33F25B0528; CDC-21142-XN1A/10801902193275, 10801902196504, 50801902116821/33F25D0441, 33F25E0816, 33F25F0210, 33F25J0418, 33F26B0438, 33F26B0809, 33F26C0018, 33F24D0429; CDC-21242-XCN1A/10801902196511, 10801902193275, 10801902196511/33F24D0427, 33F24D0493, 33F24D0502, 33F24E0257, 33F24E0833, 33F24G0147, 33F24G0162, 33F24G0202, 33F24G0249, 33F24G0620, 33F24H0067, 33F24H0330, 33F24H0355, 33F24H0390, 33F24H0423, 33F24H0449, 33F24J0252, 33F24K0013, 33F24K0041, 33F24K0629, 33F24L0158.33F24M0056, 33F24M0066, 33F24M0091, 33F25A0132, 33F25A0373, 33F25B0028, 33F25B0097, 33F25B0135, 33F25C0217, 33F25C0529, 33F25C0692, 33F25D0690,33F25D0692, 33F25D0698, 33F25D0707, 33F25D0721, 33F25D0734, 33F25D0754, 33F25E0415, 33F25E1102, 33F25E1123, 33F25E1152, 33F25F0030, 33F25F0039, 33F25F0484, 33F25F0525, 33F25H0335, 33F25H0872, 33F25J0747, 33F25J0774, 33F25K0292, 33F25K0353, 33F25L0092, 33F25L0236, 33F25L0298, 33F26A1617, 33F26A1626, 33F26A1632, 33F26A1635, 33F26B0621, 33F26B0622, 33F26B1039, 33F26D0229, 33F26D0230, 33X25J0002, 33F24H0395; CDC-21242-XN1A/10801902193275, 10801902196528, 20801902123484/33F25A0378, 33F25B0029, 33F25B0098, 33F25B0341, 33F25C0420, 33F25C0530, 33F25E1093, 33F25E1124, 33F25H0286, 33F25H0362, 33F25J0775, 33F25J1040, 33F26A1618, 33F26A1627, 33F26C0453, 33F26C0881, 33X25J0001, 33F24F0996; ASK-21142-CO1/10801902214291, 10801902193275/33F24F0767, 33F24K0423, 33F25B0548, 33F25D0266, 33F25F0170, 33F25H0592, 33F25K0136, 33F26A1450, 33F26C0489, 33F24J0113; ASK-… (truncated, 10485 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: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UNHS1

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-45563-VPSB/10801902193275/33F25C0704, 33F25D0316, 33F25D0627, 33F25M0094, 33F24L0860; DLX-45563-VPSC/10801902193275, 10801902208658, 10801902210118/33F25B0509, 33F25C0340, 33F25D0255, 33F25D0628, 33F25E0767, 33F25E0901, 33F25F0227, 33F25J0448, 33F25K0036, 33F26C0104, 33F26C0107, 33F24C0257; ASK-04001-UCHD1/10801902193275, 10801902219005/33F25H0415, 33F25J0349, 33F26B0440, 33F24L0396; ASK-04001-UCHS1/10801902193275, 10801902219067/33F24L1083, 33F25D0331, 33F25E0521, 33F25E0846, 33F25K0068, 33F25K0107, 33F25M0133, 33F26A1417, 33F26C0029, 33F24K0406; ASK-04001-DU13/10801902193275, 10801902201970/33F25B0514, 33F25C0703, 33F25F0090, 33F25F0124, 33F25H0421, 33F25J0197, 33F26A1372, 33F26B0850, 33F26C0369, 33R25A0227, 33F24K0314; ASK-04001-UNHS1/10801902193275, 10801902211887, 10801902158854/33F25A0229, 33F25C0714, 33F25D0390, 33F25E0847, 33F25G0244, 33F25M0129, 33F26A1139, 33F26C0370, 33F24E0400
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2026

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

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

ALL 50 STATES
▸Full report

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

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