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Recalls affecting New York

Data last updated: September 10, 2026 at 1:16 PM UTC

17,381 recalls found
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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

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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.

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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.

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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.

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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)
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 February 11, 2026

Burlington Medical, Frontal Aprons

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8F17; UDI-DI (Product Code): 00840331297706 (FRONTALC18-C8F17-2XM ), 00840331297706 (FRONTALC8-C8F17-LF ), 00840331297706 (FRONTALC8-C8F17-LM ), 00840331297706 (FRONTALC8-C8F17-MF ), 00840331297706 (FRONTALC8-C8F17-MM ), 00840331297706 (FRONTALC8-C8F17-SF ), 00840331297706 (FRONTALC8-C8F17-SM ), 00840331297706 (FRONTALC8-C8F17-XLM ), 00840331297706 (FRONTALC8-C8F17-XSF ), 00840331297706 (FRONTALT18-C8F17-LM ), 00840331297706 (FRONTALT18-C8F17-MM ), 00840331297706 (FRONTALT28-C8F17-3XM ). 2. Model Number: R8601; UDI-DI (Product Code): 00840331258400 (FRONTALC18-R8601-2XF ), 00840331258417 (FRONTALC18-R8601-2XM ), 00840331258448 (FRONTALC8-R8601-LF ), 00840331258455 (FRONTALC8-R8601-LM ), 00840331258462 (FRONTALC8-R8601-MF ), 00840331258479 (FRONTALC8-R8601-MM ), 00840331258486 (FRONTALC8-R8601-PLUS ), 00840331258493 (FRONTALC8-R8601-SF ), 00840331258509 (FRONTALC8-R8601-SM ), 00840331258516 (FRONTALC8-R8601-XLF ), 00840331258523 (FRONTALC8-R8601-XLM ), 00840331270341 (FRONTALT18-R8601-LF ), 00840331270358 (FRONTALT18-R8601-LM ), 00840331270341 (FRONTALT18-R8601-MF ), 00840331270358 (FRONTALT18-R8601-MM ), 00840331270341 (FRONTALT18-R8601-PLUS ), 00840331270341 (FRONTALT18-R8601-SF ), 00840331270358 (FRONTALT18-R8601-SM ), 00840331270358 (FRONTALT18-R8601-XLM ), 00840331270341 (FRONTALT28-R8601-2XF ), 00840331270358 (FRONTALT28-R8601-2XM ), 00840331270358 (FRONTALT28-R8601-3XM ), 00840331270358 (FRONTALT28-R8601-4XM ), None (IFRONTALC8-R8601-2XMR ), None (IFRONTALC8-R8601-LMR ), None (IFRONTALC8-R8601-MFR ), None (IFRONTALC8-R8601-MMR ), None (IFRONTALC8-R8601-SFR ), None (IFRONTALC8-R8601-SMR ), None (IFRONTALC8-R8601-XLMR ), None (IFRONTALC8-R8601-XSFR ), None (IFRONTALC8-R8601-XSMR ), None (IFRONTALC8-R8601-LML ). 3. Model Number: R8A10; UDI-DI (Product Code): 00840331258578 (FRONTALC18-R8A10-2XM ), 00840331258608 (FRONTALC8-R8A10-LF ), 00840331258615 (FRONTALC8-R8A10-LM ), 00840331258622 (FRONTALC8-R8A10-MF ), 00840331258639 (FRONTALC8-R8A10-MM ), 00840331258646 (FRONTALC8-R8A10-PLUS ), 00840331258653 (FRONTALC8-R8A10-SF ), 00840331258660 (FRONTALC8-R8A10-SM ), 00840331258677 (FRONTALC8-R8A10-XLF ), 00840331258684 (FRONTALC8-R8A10-XLM ), 00840331258691 (FRONTALC8-R8A10-XSF ), 00840331258707 (FRONTALC8-R8A10-XSM ), 00840331270280 (FRONTALT18-R8A10-LF ), 00840331270297 (FRONTALT18-R8A10-LM ), 00840331270280 (FRONTALT18-R8A10-MF ), 00840331270297 (FRONTALT18-R8A10-MM ), 00840331270280 (FRONTALT18-R8A10-PLUS ), 00840331270280 (FRONTALT18-R8A10-SF ), 00840331270297 (FRONTALT18-R8A10-SM ), 00840331270297 (FRONTALT18-R8A10-XLM ), 00840331270297 (FRONTALT28-R8A10-2XM ), 00840331270297 (FRONTALT28-R8A10-3XM ), 00840331270297 (FRONTALT28-R8A10-4XM ), 00840331270297 (FRONTALT28-R8A10-5XM ), None (IFRONTALC8-R8A10-LMR ), None (IFRONTALC8-R8A10-MFR ), None (IFRONTALC8-R8A10-MMR ), None (IFRONTALC8-R8A10-XLMR ). 4. Model Number: R8F01; UDI-DI (Product Code): 00840331258899 (FRONTALC18-R8F01-2XM ), 00840331258929 (FRONTALC8-R8F01-LF ), 00840331258936 (FRONTALC8-R8F01-LM ), 00840331258943 (FRONTALC8-R8F01-MF ), 00840331258950 (FRONTALC8-R8F01-MM ), 00840331258936 (FRONTALS8-R8F01-LM ), 00840331258943 (FRONTALS8-R8F01-MF ), 00840331259001 (FRONTALS8-R8F01-XLM ). 5. Model Number: R8F17; UDI-DI (Product Code): 00840331259360 (FRONTALC18-R8F17-2XF ), 00840331259377 (FRONTALC18-R8F17-2XM ), 00840331259384 (FRONTALC18-R8F17-3XF ), 00840331259391 (FRONTALC18-R8F17-3XM ), 00840331259407 (FRONTALC8-R8F17-LF ), 00840331259414 (FRONTALC8-R8F17-LM ), 00840331259421 (FRONTALC8-R8F17-MF ), 00840331259438 (FRONTALC8-R8F17-MM ), 00840331259445 (FRONTALC8-R8F17-PLUS ), 00840331259452 (FRONTALC8-R8F17-SF ), 00840331259469 (FRONTALC8-R8F17-SM ), 00840331259476 (FRONTALC8-R8F17-XLF ), 00840331259483 (FRONTALC8-R8F17-XLM ), 00840331259490 (FRONTALC8-R8F17-XSF ), 00840331259506 (FRONTALC8-R8F17-XSM ), 00840331259407 (FRONTALS8-R8F17-LF ), 00840331259414 (FRONTALS8-R8F17-LM ), 00840331259414 (FRONTALS8-R8F17-MF ), 00840331259438 (FRONTALS8-R8F17-MM ), 00840331259452 (FRONTALS8-R8F17-SF ), 00840331259469 (FRONTALS8-R8F17-SM ), 00840331259476 (FRONTALS8-R8F17-XLF ), 00840331259483 (FRONTALS8-R8F17-XLM ), 00840331259506 (FRONTALS8-R8F17-XSM ), 00840331270228 (FRONTALT18-R8F17-LF ), 00840331270235 (FRONTALT18-R8F17-LM ), 00840331270228 (FRONTALT18-R8F17-MF ), 00840331270235 (FRONTALT18-R8F17-MM ), 00840331270228 (FRONTALT18-R8F17-PLUS ), 00840331270228 (FRONTALT18-R8F17-SF ), 00840331270235 (FRONTALT18-R8F17-SM ), 00840331270228 (FRONTALT18-R8F17-XLF ), 00840331270235 (FRONTALT18-R8F17-XLM ), 00840331270228 (FRONTALT18-R8F17-XSF ), 00840331270235 (FRONTALT18-R8F17-XSM ), 00840331270228 (FRONTALT28-R8F17-2XF ), 00840331270235 (FRONTALT28-R8F17-2XM ), 00840331270228 (FRONTALT28-R8F17-3XF ), 00840331270235 (FRONTALT28-R8F17-3XM ), 00840331270228 (FRONTALT28-R8F17-4XF ), 00840331270235 (FRONTALT28-R8F… (truncated, 12818 characters total — see the official FDA record for the full value)
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Vest

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8PVEST; UDI-DI (Product Code): 00840331297652 (VESTC18-C8PVEST-2XM ), 00840331297652 (VESTC8-C8PVEST-LF ), 00840331297652 (VESTC8-C8PVEST-LM ), 00840331297652 (VESTC8-C8PVEST-MF ), 00840331297652 (VESTC8-C8PVEST-MM ), 00840331297652 (VESTC8-C8PVEST-SF ), 00840331297652 (VESTC8-C8PVEST-SM ), 00840331297652 (VESTC8-C8PVEST-XLM ), 00840331297652 (VESTT18-C8PVEST-LF ), 00840331297652 (VESTT18-C8PVEST-LM ), 00840331297652 (VESTT18-C8PVEST-MM ), 00840331297652 (VESTT18-C8PVEST-PLUS ), 00840331297652 (VESTT18-C8PVEST-SM ), 00840331297652 (VESTT28-C8PVEST-3XM ), 00840331297652 (VESTT28-C8PVEST-4XM ), 00840331297652 (VESTT28-C8PVEST-5XM ). 2. Model Number: C8VEST; UDI-DI (Product Code): 00840331297645 (VESTC18-C8VEST-2XM ), 00840331297645 (VESTC8-C8VEST-LF ), 00840331297645 (VESTC8-C8VEST-LM ), 00840331297645 (VESTC8-C8VEST-MF ), 00840331297645 (VESTC8-C8VEST-MM ), 00840331297645 (VESTC8-C8VEST-PLUS ), 00840331297645 (VESTC8-C8VEST-SF ), 00840331297645 (VESTC8-C8VEST-SM ), 00840331297645 (VESTC8-C8VEST-XLF ), 00840331297645 (VESTC8-C8VEST-XLM ), 00840331297645 (VESTC8-C8VEST-XSF ), 00840331297645 (VESTT18-C8VEST-LM ), 00840331297645 (VESTT18-C8VEST-MM ), 00840331297645 (VESTT18-C8VEST-SM ), 00840331297645 (VESTT18-C8VEST-XLM ), 00840331297645 (VESTT18-C8VEST-XSM ), 00840331297645 (VESTT28-C8VEST-2XM ), 00840331297645 (VESTT28-C8VEST-4XF ). 3. Model Number: R8FVEST; UDI-DI (Product Code): 00840331259520 (VESTC18-R8FVEST-2XF ), 00840331259537 (VESTC18-R8FVEST-2XM ), 00840331259551 (VESTC18-R8FVEST-3XM ), 00840331259568 (VESTC8-R8FVEST-LF ), 00840331259575 (VESTC8-R8FVEST-LM ), 00840331259582 (VESTC8-R8FVEST-MF ), 00840331259599 (VESTC8-R8FVEST-MM ), 00840331259605 (VESTC8-R8FVEST-PLUS ), 00840331259612 (VESTC8-R8FVEST-SF ), 00840331259629 (VESTC8-R8FVEST-SM ), 00840331259636 (VESTC8-R8FVEST-XLF ), 00840331259643 (VESTC8-R8FVEST-XLM ), 00840331259650 (VESTC8-R8FVEST-XSF ), 00840331269741 (VESTT18-R8FVEST-LF ), 00840331269758 (VESTT18-R8FVEST-LM ), 00840331269741 (VESTT18-R8FVEST-MF ), 00840331269758 (VESTT18-R8FVEST-MM ), 00840331269741 (VESTT18-R8FVEST-PLUS ), 00840331269741 (VESTT18-R8FVEST-SF ), 00840331269758 (VESTT18-R8FVEST-SM ), 00840331269741 (VESTT18-R8FVEST-XLF ), 00840331269758 (VESTT18-R8FVEST-XLM ), 00840331269758 (VESTT18-R8FVEST-XSM ), 00840331269741 (VESTT28-R8FVEST-2XF ), 00840331269758 (VESTT28-R8FVEST-2XM ), 00840331269741 (VESTT28-R8FVEST-3XF ), 00840331269758 (VESTT28-R8FVEST-3XM ), 00840331269741 (VESTT28-R8FVEST-4XF ), 00840331269758 (VESTT28-R8FVEST-4XM ), 00840331269741 (VESTT28-R8FVEST-5XF ), 00840331269758 (VESTT28-R8FVEST-5XM ), 00840331269741 (VESTT38-R8FVEST-6XF ), 00840331269758 (VESTT38-R8FVEST-6XM ), 00840331269741 (VESTT38-R8FVEST-8XF ), 00840331269758 (VESTT38-R8FVEST-8XM ), None (IVESTC8-R8FVEST-MFR ), None (IVESTC8-R8FVEST-MML ), None (IVESTC8-R8FVEST-LFL ), None (IVESTC8-R8FVEST-LFR ), None (IVESTC8-R8FVEST-LML ), None (IVESTC8-R8FVEST-MMR ), None (IVESTC8-R8FVEST-PLUSL ), None (IVESTC8-R8FVEST-SFR ), None (IVESTC8-R8FVEST-SFS ), None (IVESTC8-R8FVEST-SMR ), None (IVESTC8-R8FVEST-SMS ), None (IVESTC8-R8FVEST-XLML ), None (IVESTC8-R8FVEST-XSFS ), None (IVESTC8-R8FVEST-MMXL ), None (IVESTC8-R8FVEST-XLMXL ), None (IVESTC8-R8FVEST-LMR ), None (IVESTC8-R8FVEST-XSFR ), None (IVESTC8-R8FVEST-XSMR ). 4. Model Number: R8PVEST; UDI-DI (Product Code): None (IVESTC8-R8PVEST-LMR ), None (IVESTC8-R8PVEST-SMR ), 00840331259841 (VESTC18-R8PVEST-2XF ), 00840331259858 (VESTC18-R8PVEST-2XM ), 00840331259865 (VESTC18-R8PVEST-3XF ), 00840331259872 (VESTC18-R8PVEST-3XM ), 00840331259889 (VESTC8-R8PVEST-LF ), 00840331259896 (VESTC8-R8PVEST-LM ), 00840331259902 (VESTC8-R8PVEST-MF ), 00840331259919 (VESTC8-R8PVEST-MM ), 00840331259926 (VESTC8-R8PVEST-PLUS ), 00840331259933 (VESTC8-R8PVEST-SF ), 00840331259940 (VESTC8-R8PVEST-SM ), 00840331259957 (VESTC8-R8PVEST-XLF ), 00840331259964 (VESTC8-R8PVEST-XLM ), 00840331259971 (VESTC8-R8PVEST-XSF ), 00840331259988 (VESTC8-R8PVEST-XSM ), 00840331269680 (VESTT18-R8PVEST-LF ), 00840331269697 (VESTT18-R8PVEST-LM ), 00840331269680 (VESTT18-R8PVEST-MF ), 00840331269697 (VESTT18-R8PVEST-MM ), 00840331269680 (VESTT18-R8PVEST-PLUS ), 00840331269680 (VESTT18-R8PVEST-SF ), 00840331269697 (VESTT18-R8PVEST-SM ), 00840331269680 (VESTT18-R8PVEST-XLF ), 00840331269697 (VESTT18-R8PVEST-XLM ), 00840331269697 (VESTT18-R8PVEST-XSM ), 00840331269680 (VESTT28-R8PVEST-2XF ), 00840331269697 (VESTT28-R8PVEST-2XM ), 00840331269680 (VESTT28-R8PVEST-3XF ), 00840331269697 (VESTT28-R8PVEST-3XM ), 00840331269680 (VESTT28-R8PVEST-4XF ), 00840331269697 (VESTT28-R8PVEST-4XM ), 00840331269680 (VESTT28-R8PVEST-5XF ), 00840331269697 (VESTT28-R8PVEST-5XM ), 00840331269680 (VESTT38-R8PVEST-6XF ), 00840331269697 (VESTT38-R8PVEST-6XM ), 00840331269680 (VESTT38-R8PVEST-7XF ), 00840331269697 (VESTT38-R8PVEST-7XM ), 00840331269680 (VESTT38-R8PVEST-8XF ), … (truncated, 18537 characters total — see the official FDA record for the full value)
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: BATB; UDI-DI (Product Code): 00197513011941 (BATC18-R8BATB-2XF ), 00197513011941 (BATC18-R8BATB-3XF ), 00197513011941 (BATC8-R8BATB-LF ), 00197513011941 (BATC8-R8BATB-LM ), 00197513011941 (BATC8-R8BATB-MF ), 00197513011941 (BATC8-R8BATB-MM ), 00197513011941 (BATC8-R8BATB-PLUS ), 00197513011941 (BATC8-R8BATB-SF ), 00197513011941 (BATC8-R8BATB-XLF ), 00197513011941 (BATC8-R8BATB-XLM ), 00197513011941 (BATC8-R8BATB-XSF ). 2. Model Number: BATH; UDI-DI (Product Code): 00197513011934 (BATC18-R8BATH-2XF ), 00197513011934 (BATC18-R8BATH-2XM ), 00197513011934 (BATC18-R8BATH-3XF ), 00197513011934 (BATC18-R8BATH-3XM ), 00197513011934 (BATC8-R8BATH-LF ), 00197513011934 (BATC8-R8BATH-LM ), 00197513011934 (BATC8-R8BATH-MF ), 00197513011934 (BATC8-R8BATH-MM ), 00197513011934 (BATC8-R8BATH-PLUS ), 00197513011934 (BATC8-R8BATH-SF ), 00197513011934 (BATC8-R8BATH-SM ), 00197513011934 (BATC8-R8BATH-XLF ), 00197513011934 (BATC8-R8BATH-XLM ), 00197513011934 (BATC8-R8BATH-XSF ), 00197513011934 (BATC8-R8BATH-XLF ). 3. Model Number: BATM; UDI-DI (Product Code): 00197513011927 (BATC18-R8BATM-2XF ), 00197513011927 (BATC18-R8BATM-2XM ), 00197513011927 (BATC18-R8BATM-3XF ), 00197513011927 (BATC18-R8BATM-3XM ), 00197513011927 (BATC8-R8BATM-LF ), 00197513011927 (BATC8-R8BATM-LM ), 00197513011927 (BATC8-R8BATM-MF ), 00197513011927 (BATC8-R8BATM-MM ), 00197513011927 (BATC8-R8BATM-PLUS ), 00197513011927 (BATC8-R8BATM-SF ), 00197513011927 (BATC8-R8BATM-SM ), 00197513011927 (BATC8-R8BATM-XLF ), 00197513011927 (BATC8-R8BATM-XLM ), 00197513011927 (BATC8-R8BATM-XSF ), 00197513011927 (BATC8-R8BATM-XSM ).
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Wrap Aprons.

Potential for attenuation degradation over time, decreasing the lifespan.

ALL 50 STATES
▸Full report

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8EURO; UDI-DI (Product Code): 00840331297683 (WRAPC8-C8EURO-LF ), 00840331297683 (WRAPC8-C8EURO-LM ), 00840331297683 (WRAPC8-C8EURO-MF ), 00840331297683 (WRAPC8-C8EURO-MM ), 00840331297683 (WRAPC8-C8EURO-SF ), 00840331297683 (WRAPC8-C8EURO-SM ), 00840331297683 (WRAPC8-C8EURO-XLM ), 00840331297683 (WRAPT18-C8EURO-LF ), 00840331297683 (WRAPT18-C8EURO-LM ), 00840331297683 (WRAPT18-C8EURO-MM ), 00840331297683 (WRAPT18-C8EURO-PLUS ), 00840331297683 (WRAPT18-C8EURO-SM ). 2. Model Number: C8F111; UDI-DI (Product Code): 00840331297690 (WRAPT18-C8F111-MM). 3. Model Number: R8EURO; UDI-DI (Product Code): 00840331258721 (WRAPC18-R8EURO-2XF ), 00840331258738 (WRAPC18-R8EURO-2XM ), 00840331258745 (WRAPC18-R8EURO-3XF ), 00840331258752 (WRAPC18-R8EURO-3XM ), 00840331258769 (WRAPC8-R8EURO-LF ), 00840331258776 (WRAPC8-R8EURO-LM ), 00840331258783 (WRAPC8-R8EURO-MF ), 00840331258790 (WRAPC8-R8EURO-MM ), 00840331258806 (WRAPC8-R8EURO-PLUS ), 00840331258813 (WRAPC8-R8EURO-SF ), 00840331258820 (WRAPC8-R8EURO-SM ), 00840331258837 (WRAPC8-R8EURO-XLF ), 00840331258844 (WRAPC8-R8EURO-XLM ), 00840331258851 (WRAPC8-R8EURO-XSF ), 00840331258868 (WRAPC8-R8EURO-XSM ), 00840331258769 (WRAPS8-R8EURO-LF ), 00840331258776 (WRAPS8-R8EURO-LM ), 00840331258783 (WRAPS8-R8EURO-MF ), 00840331258790 (WRAPS8-R8EURO-MM ), 00840331258813 (WRAPS8-R8EURO-SF ), 00840331258820 (WRAPS8-R8EURO-SM ), 00840331258837 (WRAPS8-R8EURO-XLF ), 00840331258844 (WRAPS8-R8EURO-XLM ), 00840331270044 (WRAPT18-R8EURO-LF ), 00840331270051 (WRAPT18-R8EURO-LM ), 00840331270051 (WRAPT18-R8EURO-MF ), 00840331270051 (WRAPT18-R8EURO-MM ), 00840331270044 (WRAPT18-R8EURO-PLUS ), 00840331270044 (WRAPT18-R8EURO-SF ), 00840331270051 (WRAPT18-R8EURO-SM ), 00840331270044 (WRAPT18-R8EURO-XLF ), 00840331270051 (WRAPT18-R8EURO-XLM ), 00840331270051 (WRAPT18-R8EURO-XSM ), 00840331270044 (WRAPT28-R8EURO-2XF ), 00840331270051 (WRAPT28-R8EURO-2XM ), 00840331270044 (WRAPT28-R8EURO-3XF ), 00840331270051 (WRAPT28-R8EURO-3XM ), 00840331270044 (WRAPT28-R8EURO-4XF ), 00840331270051 (WRAPT28-R8EURO-4XM ), 00840331270044 (WRAPT28-R8EURO-5XF ), 00840331270051 (WRAPT28-R8EURO-5XM ), 00840331270044 (WRAPT38-R8EURO-6XF ), 00840331270051 (WRAPT38-R8EURO-6XM ), 00840331270044 (WRAPT38-R8EURO-7XF ), 00840331270051 (WRAPT38-R8EURO-7XM ), 00840331270044 (WRAPT38-R8EURO-8XF ), 00840331270051 (WRAPT38-R8EURO-8XM ), None (IWRAPC8-R8EURO-LFR ), None (IWRAPC8-R8EURO-MFR ), None (IWRAPC8-R8EURO-PLUSL ), None (IWRAPC8-R8EURO-SFS ). 4. Model Number: R8F111; UDI-DI (Product Code): 00840331259049 (WRAPC18-R8F111-2XF ), 00840331259056 (WRAPC18-R8F111-2XM ), 00840331259063 (WRAPC18-R8F111-3XF ), 00840331259087 (WRAPC8-R8F111-LF ), 00840331259094 (WRAPC8-R8F111-LM ), 00840331259100 (WRAPC8-R8F111-MF ), 00840331259117 (WRAPC8-R8F111-MM ), 00840331259124 (WRAPC8-R8F111-PLUS ), 00840331259131 (WRAPC8-R8F111-SF ), 00840331259148 (WRAPC8-R8F111-SM ), 00840331259155 (WRAPC8-R8F111-XLF ), 00840331259162 (WRAPC8-R8F111-XLM ), 00840331270105 (WRAPT18-R8F111-LF ), 00840331270112 (WRAPT18-R8F111-LM ), 00840331270105 (WRAPT18-R8F111-MF ), 00840331270112 (WRAPT18-R8F111-MM ), 00840331270105 (WRAPT18-R8F111-PLUS ), 00840331270105 (WRAPT18-R8F111-SF ), 00840331270112 (WRAPT18-R8F111-SM ), 00840331270105 (WRAPT18-R8F111-XLF ), 00840331270112 (WRAPT18-R8F111-XLM ), 00840331270112 (WRAPT18-R8F111-XSM ), 00840331270105 (WRAPT28-R8F111-2XF ), 00840331270112 (WRAPT28-R8F111-2XM ), 00840331270105 (WRAPT28-R8F111-3XF ), 00840331270112 (WRAPT28-R8F111-3XM ), 00840331270105 (WRAPT28-R8F111-4XF ), 00840331270112 (WRAPT28-R8F111-4XM ), 00840331270105 (WRAPT28-R8F111-5XF ), 00840331270112 (WRAPT28-R8F111-5XM ), 00840331270105 (WRAPT38-R8F111-6XF ), 00840331270112 (WRAPT38-R8F111-6XM ), 00840331270112 (WRAPT38-R8F111-8XM ), None (IWRAPC8-R8F111-MML ). 5. Model Number: R8F112; UDI-DI (Product Code): 00840331259209 (WRAPC18-R8F112-2XF ), 00840331259223 (WRAPC18-R8F112-3XF ), 00840331259247 (WRAPC8-R8F112-LF ), 00840331259254 (WRAPC8-R8F112-LM ), 00840331259261 (WRAPC8-R8F112-MF ), 00840331259278 (WRAPC8-R8F112-MM ), 00840331259292 (WRAPC8-R8F112-SF ), 00840331259308 (WRAPC8-R8F112-SM ), 00840331259315 (WRAPC8-R8F112-XLF ), 00840331259322 (WRAPC8-R8F112-XLM ), 00840331259339 (WRAPC8-R8F112-XSF ), 00840331259346 (WRAPC8-R8F112-XSM ), 00840331270167 (WRAPT18-R8F112-LF ), 00840331270174 (WRAPT18-R8F112-LM ), 00840331270167 (WRAPT18-R8F112-MF ), 00840331270174 (WRAPT18-R8F112-MM ), 00840331270167 (WRAPT18-R8F112-PLUS ), 00840331270167 (WRAPT18-R8F112-SF ), 00840331270174 (WRAPT18-R8F112-SM ), 00840331270167 (WRAPT18-R8F112-XLF ), 00840331270174 (WRAPT18-R8F112-XLM ), 00840331270174 (WRAPT18-R8F112-XSM ), 00840331270174 (WRAPT28-R8F112-2XM ), 00840331270167 (WRAPT28-R8F112-3XF ), 00840331270174 (WRAPT28-R8F112-4XM ), 00840331270167 (WRAPT28-R8F112-5XF ), 00840331270105 (WRAPT38-R8F112-6XF ), 00840331270105 (… (truncated, 13255 characters total — see the official FDA record for the full value)
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

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

Recall #:
98250
Lot/product code:
Catalog Number: 8015 UDI-DI codes: 10885403210747 10885403210754 10885403210891 10885403212048 10885403222108 10885403224614 10885403515231 10885403516023 10885403519215 10885403519284 10885403519291 10885403801518 10885403801532 10885403801549 Serial Numbers: 12360968 12360983 12360985 12360986 12360987 12360988 12360989 12360990 12360991 12360992 12360993 12360994 12360995 12360996 12360997 12360998 12360999 12361000 12361001 12361002 12361003 12361004 12361005 12361006 12361008 12361010 12361013 12361017 12361018 12361019 12361020 12361021 12361022 12361024 12361026 12361027 12361028 12361029 12361030 12361031 12383470 12383471 12383472 12386884 12386885 12388269 12389653 12389660 12389680 12389683 12389691 12389698 12389715 12389727 12389730 12389734 12389738 12389740 12389741 12390061 12390104 12390107 12390118 12390133 12390155 12390184 12390187 12390199 12390219 12390236 12390239 12390257 12390258 12390271 12390274 12390290 12390293 12390300 12390301 12390302 12390558 12390560 12390578 12390597 12390603 12390619 12390620 12390634 12390635 12390654 12390662 12390666 12390670 12390678 12390701 12390721 12390722 12390729 12390731 12390736 12390738 12393833 12393834 12393836 12393843 12393870 12393916 12393922 12393929 12393953 12393954 12394011 12394012 12394013 12394015 12394040 12394066 12394105 12394106 12394126 12394171 12394179 12394209 12394219 12394222 12394283 12394284 12394290 12394293 12394298 12394301 12394596 12394619 12394643 12394646 12394659 12394672 12394673 12394716 12394745 12394746 12394748 12394780 12394781 12394782 12394783 12394844 12394848 12394849 12394871 12394882 12394912 12394920 12394924 12394925 12394929 12394932 12394937 12395206 12395235 12395236 12395237 12395267 12395268 12395303 12395304 12395305 12395309 12395310 12395336 12395383 12395424 12395432 12395433 12395455 12395457 12395458 12395462 12395474 12395479 12395492 12395507 12395509 12395524 12395546 12395836 12395849 12395856 12395877 12395928 12395933 12395938 12395957 12395971 12395972 12395978 12395983 12395986 12395997 12396041 12396049 12396050 12396051 12396052 12396058 12396070 12396071 12396091 12396099 12396103 12396104 12396105 12396106 12396318 12396334 12396337 12396338 12396458 12396459 12396460 12396461 12396462 12396494 12396495 12396496 12396497 12396498 12396515 12396516 12396517 12396518 12396520 12396619 12396620 12396622 12396623 12396624 12396704 12396705 12396706 12396707 12396763 12396767 12396771 12397039 12397040 12397041 12397042 12397061 12397063 12397077 12397080 12397087 12397088 12397117 12397129 12397138 12397147 12397171 12397177 12397180 12397192 12397195 12397207 12397217 12397218 12397275 12397276 12397282 12397290 12397293 12397307 12397356 12397374 12397375 12397376 12397377 12397378 12397379 12397380 12397403 12397412 12397418 12397420 12397421 12397423 12397426 12397427 12397430 12397680 12397681 12397689 12397690 12397691 12397692 12397726 12397727 12397806 12397807 12397808 12397826 12397827 12397829 12397830 12397833 12397834 12397835 12397848 12397863 12397866 12398135 12398772 12404358 12404359 12404583 12404584 12404586 12404587 12404588 12404595 12404597 12404603 12404605 12404606 12404607 12404608 12404609 12404610 12404789 12404796 12404801 12404802 12404803 12404804 12404863 12404864 12404886 12404887 12404888 12404895 12404897 12404898 12404899 12404900 12404906 12404907 12404908 12404927 12404928 12404930 12404931 12404945 12404953 12404954 12404955 12404977 12404978 12404979 12404980 12404982 12404983 12404996 12405002 12405013 12405019 12405020 12405219 12405220 12405223 12405224 12405231 12405331 12405332 12405337 12405339 12405341 12405513 12405514 12405515 12407888 12418322 12418323 12418324 12418325 12418326 12418332 12418338 12418345 12418352 12418353 12418354 12418360 12418376 12418377 12418378 12418379 12418385 12418386 12418387 12418388 12418389 12418390 12418396 12418397 12418410 12418412 12418419 12418420 12418429 12418432 12418433 12418436 12418437 12418438 12418439 12418440 12418461 12418462 12418463 12418502 12418513 12418514 12418526 12418527 12418528 12418529 12418530 12418552 12418558 12418559 12418562 12418563 12418573 12418574 12418591 12418592 12418593 12418611 12418612 12418613 12418644 12418660 12418666 12418792 12418807 12418808 12418835 12418861 12418862 12418868 12418874 12418885 12418886 12418897 12418903 12418906 12418912 12418913 12418919 12418925 12418927 12418929 12418940 12418941 12418942 12418943 12418949 12418950 12418951 12418957 12418958 12418959 12418965 12418966 12418967 12418968 12418969 12418970 12418981 12418982 12418983 12418984 12418985 12418986 12419006 12419012 12419013 12419014 12419032 12419033 12419034 12419047 12419048 12419059 12419060 12419066 12419082 12419083 12419084 12419096 12419105 12419108 12419118 12419119 12419120 12419121 12419128 12419133 12419145 12419146 12419147 12419148 12419149 12419150 12419151 12419152 12419153 12419164 12419165 12419174 12419177 12419178 12419179 12419180 12419186 12419187 1241… (truncated, 8867432 characters total — see the official FDA record for the full value)
Recalling firm:
CareFusion 303, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

Burlington Medical, Half Aprons.

Potential for attenuation degradation over time, decreasing the lifespan.

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

Recall #:
98415
Lot/product code:
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8HALF1B; UDI-DI (Product Code): 00840331272291 (HALF18-R8HALF1B). 2. Model Number: R8HALF1H; UDI-DI (Product Code): 00840331272314 (HALF18-R8HALF1H). 3. Model Number: R8HALF2B; UDI-DI (Product Code): 00840331272338 (HALF28-R8HALF2B). 4. Model Number: R8HALF2H; UDI-DI (Product Code): 00840331272345 (HALF28-R8HALF2H). 5. Model Number: R8HALF3B; UDI-DI (Product Code): 00840331272352 (HALF38-R8HALF3B). 6. Model Number: R8HALF3H; UDI-DI (Product Code): 00840331272369 (HALF38-R8HALF3H). 7. Model Number: R8HALF4B; UDI-DI (Product Code): 00840331272376 (HALF48-R8HALF4B). 8. Model Number: R8HALF4H; UDI-DI (Product Code): 00840331272383 (HALF48-R8HALF4H). 9. Model Number: R8HALF5B; UDI-DI (Product Code): 00840331272390 (HALF58-R8HALF5B). 10. Model Number: R8HALF5H; UDI-DI (Product Code): 00840331272406 (HALF58-R8HALF5H). 11. Model Number: R8HALF6B; UDI-DI (Product Code): 00840331272420 (HALF68-R8HALF6B). 12. Model Number: R8HALF6H; UDI-DI (Product Code): 00840331272352 (HALF68-R8HALF6H). 13. Model Number: R8HALFSETB; UDI-DI (Product Code): 00840331272413 (HALFSET8-R8HALFSETB). 14. Model Number: R8HALFSETH; UDI-DI (Product Code): 00840331272420 (HALFSET8-R8HALFSETH). 15. Model Number: S8HALF1H; UDI-DI (Product Code): 00840331272451 (HALF18-S8HALF1H). 16. Model Number: S8HALF2B; UDI-DI (Product Code): 00840331272475 (HALF28-S8HALF2B). 17. Model Number: S8HALF2H; UDI-DI (Product Code): 00840331272482 (HALF28-S8HALF2H). 18. Model Number: S8HALF3B; UDI-DI (Product Code): 00840331272499 (HALF38-S8HALF3B). 19. Model Number: S8HALF3H; UDI-DI (Product Code): 00840331272505 (HALF38-S8HALF3H). 20. Model Number: S8HALF4B; UDI-DI (Product Code): 00840331272512 (HALF48-S8HALF4B). 21. Model Number: S8HALF4H; UDI-DI (Product Code): 00840331272529 (HALF48-S8HALF4H). 22. Model Number: S8HALF5B; UDI-DI (Product Code): 00840331272536 (HALF58-S8HALF5B). 23. Model Number: S8HALF5H; UDI-DI (Product Code): 00840331272543 (HALF58-S8HALF5H). 24. Model Number: S8HALF6H; UDI-DI (Product Code): 00840331272499 (HALF68-S8HALF6H). 25. Model Number: S8HALFSETH; UDI-DI (Product Code): 00840331272567 (HALFSET8-S8HALFSETH). 26. Model Number: U8HALF3B; UDI-DI (Product Code): 00840331272635 (HALF38-U8HALF3B). 27. Model Number: U8HALF3H; UDI-DI (Product Code): 00840331272642 (HALF38-U8HALF3H). 28. Model Number: U8HALF4H; UDI-DI (Product Code): 00840331272666 (HALF48-U8HALF4H). 29. Model Number: U8HALF5H; UDI-DI (Product Code): 00840331272680 (HALF58-U8HALF5H). 30. Model Number: U8HALF6H; UDI-DI (Product Code): 00840331272635 (HALF68-U8HALF6H).
Recalling firm:
Burlington Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2026

TMJ Bilateral Implants, REF: CHG020

Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.

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

Recall #:
98509
Lot/product code:
UDI-DI: 07613327626575, Lot: 2508181038
Recalling firm:
TMJ Solutions Inc
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Class IIModerate risk
DrugRecalled February 10, 2026

Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,

Not guaranteed to be germ-free: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.

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

Recall #:
D-0339-2026
Lot/product code:
Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Recalling firm:
LEO PHARMA INC
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UnclassifiedRisk not yet known
Medical deviceRecalled February 10, 2026

Artegraft Vascular Graft; REF#: AG740;

Labeling mix-up resulting in the incorrect lot outer packaging of product.

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

Recall #:
98409
Lot/product code:
REF#: AG740; UDI-DI: 00316837000299; Serial Number: 24GG298-022; Expiration Date: 28Jun2027;
Recalling firm:
LeMaitre Vascular, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled February 10, 2026

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System

Drill plates manufactured not meeting quality requirements can result in a bone cut in excess 00800"(2.8448mm)

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

Recall #:
98516
Lot/product code:
Lot # 25092204BB/ UDI:00810832032434
Recalling firm:
Orthalign, Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled February 10, 2026

EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.

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

Recall #:
98412
Lot/product code:
Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; Outer Box UDI: 08714729880394; Inner Box UDI: 08714729880387; Outer Box Lot#s: 37435463, 37522541, 37528545, 37546847, 37546850, 37546849, 37550500, 37592036, 37732292; Inner Box Lot#s: 37435462, 37514809, 37525231, 37536563, 37536564, 37536562, 37546840, 37583642, 37731897;
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 10, 2026

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

Drill plates manufactured not meeting quality requirements can result in a bone cut in excess 00800"(2.8448mm)

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

Recall #:
98516
Lot/product code:
Lot # 25091103BB/ UDI: 00810832032427
Recalling firm:
Orthalign, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 10, 2026

Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"

Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.

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

Recall #:
98484
Lot/product code:
MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 9, 2026

Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.

Defective Delivery System: Missing or duplicated needles within the injection kit

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

Recall #:
D-0340-2026
Lot/product code:
Lot Q4E0112A, Exp.: 30 Apr 2027
Recalling firm:
Meitheal Pharmaceuticals, Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled February 9, 2026

Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable

It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

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

Recall #:
98400
Lot/product code:
List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
Recalling firm:
Abbott Diagnostics Scarborough, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 6, 2026

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK

The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

ALL 50 STATES
▸Full report

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

Recall #:
98317
Lot/product code:
Device Item/UDI-DI: RF4001-01BK/311917178691, RF4007-01/50428560402, RF4019-01/708820721098, RF4023-01/21292009335, RF4031-01/41220136131, RF4048-01/75450843576, RF4066-01/11822002783, RF4209-01/36800234567, RF4H01-01BK/21292006112, RF4H01-40/21292009793. International: RF4i29-11BK/N/A, RF4i81-11BK/N/A, RF4i82-11BK/21292012229, RF4i82-12BK/21292009984. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX GO Owner's Booklet/ RF4TVH03 Rev 57 and prior, TRUE METRIX GO Owner's Booklet (English)/RF4TVH35 Rev 51 and prior, TRUE METRIX GO Owner's Booklet (Spanish)/RF4TVH35S Rev 51 and prior, TRUE METRIX GO Blood Glucose Monitoring System IFU Trividia House Brand/ RF4ITV16 Rev 55 and prior, TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health UK Limited/ RF4UKT16 Rev 56 and prior, Trividia Health LATAM- TRUE METRIX GO System IFU/ RF4LAT16 Rev 51 and prior, TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health Australia/ RF4AUT16 Rev 57 and prior. Device serial numbers: Prefix "F" followed by an eight-digit numeric sequence.
Recalling firm:
Trividia Health, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 6, 2026

Artelon FlexBand Plus Ref: 41054 & 41057

Augmentation devices failed bacterial endotoxin testing.

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▸Full report

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

Recall #:
98399
Lot/product code:
REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033
Recalling firm:
International Life Sciences
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 6, 2026

Artelon FlexBand Dynamic Matrix Ref: 31057

Augmentation devices failed bacterial endotoxin testing.

ALL 50 STATES
▸Full report

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

Recall #:
98399
Lot/product code:
A10011001/GTIN: 00850003396019
Recalling firm:
International Life Sciences
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 6, 2026

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-01, Meijer TRUE METRIX AIR Kit/REA4019-01, Publix TRUE METRIX AIR Kit/REA4020-01, Discount Drug Mart TRUE METRIX AIR Kit/REA4025-01, HEB TRUE METRIX AIR Kit/REA4031-01, SunmarkTRUE METRIX AIR Kit/REA4054-01, Rite AidTRUE METRIX AIR Kit/REA4066-01, Centerwell TRUE METRIX AIR Kit/REA4081-01, HumanaTRUE METRIX AIR Meter Only/REA4081-40, Centerwell TRUE METRIX AIR Starter Kit/REA4081-43, Healthmart TRUE METRIX AIR Kit/REA4089-01, Relion TRUE METRIX AIR Kit/REA4094-01, Relion TRUE METRIX AIR Kit/REA4094-01RX, Kroger TRUE METRIX AIR Kit/REA4203-01, Foster and Thrive TRUE METRIX AIR Kit/REA4211-01, TRUE METRIX AIR Kit/REA4H01-01, TRUE METRIX AIR NFRS Meter Only/REA4H01-40, TRUE METRIX AIR NFRS Starter Kit/REA4H01-43, TRUE METRIX AIR Kit (mg/dL)/REA4i03-01, TRUE METRIX AIR Starter Kit (mg/dL)/REA4i03-02, Walmart (MediMart) TRUE METRIX AIR Meter Only (Mexico - mg/dL)/REA4i04-00, TRUE METRIX AIR Kit (Australia - mmol/L)/REA4i81-11, TRUE METRIX AIR Kit (United Kingdom - mmol/L)/REA4i82-11, TRUE METRIX AIR Starter Kit (United Kingdom - mmol/L)/REA4i82-12

The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

ALL 50 STATES
▸Full report

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

Recall #:
98317
Lot/product code:
Device Item/UDI-DI: REA4001-01/311917173894, REA4002-01/96295129267, REA4007-01/50428354766, REA4011-01/87701427398, REA4019-01/708820685659, REA4020-01/41415072787, REA4025-01/93351022784, REA4031-01/41220009169, REA4054-01/10939742445, REA4066-01/11822590051, REA4081-01/21292015015, REA4081-40/21292007164, REA4081-43/21292007584, REA4089-01/52569139042, REA4094-01/681131240154, REA4094-01RX/681131403214, REA4203-01/41260007354, REA4211-01/10939958617, REA4H01-01/21292007010, REA4H01-40/21292007447, REA4H01-43/21292007911, International: REA4i03-01/N/A, REA4i03-02/N/A, REA4i04-00/21292012731, REA4i81-11/N/A, REA4i82-11/21292012212, REA4i82-12/21292009991. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX AIR Owner's Booklet/ REA4TVH03 Rev 57 and prior, TRUE METRIX AIR Owner's Booklet (English)/ REA4TVH35 Rev 51 and prior, TRUE METRIX AIR Owner's Booklet (Spanish)/ REA4TVH35S Rev 51 and prior, Relion (Walmart) TRUE METRIX AIR Owners Booklet/ REA4RLN03 Rev 52 and prior, Relion (Walmart) TRUE METRIX AIR Owner's Booklet - English/ REA4RLN35 Rev 52 and prior, TRUE METRIX AIR Owner's Booklet International Trividia House Brand/ REA4ITV03 Rev 55 and prior, TRUE METRIX AIR Owners Booklet for Trividia Health UK Limited/ REA4UKT03 Rev 55 and prior, Trividia Health LATAM - TRUE METRIX AIR Owners Booklet/ REA4LAT03 Rev 51 and prior, TRUE METRIX AIR Owners Booklet for Trividia Health Australia/ REA4AUT03 Rev 58 and prior. Device serial numbers: Prefixes "TB" or "TA" followed by a seven-digit numeric sequence.
Recalling firm:
Trividia Health, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 6, 2026

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GNP TRUE METRIX Meter Only/RE4011-00, GNP TRUE METRIX Kit /RE4011-01, MEIJER TRUE METRIX Kit/RE4019-01, FRED'S TRUE METRIX Kit/RE4023-01, DISCOUNT DRUG TRUE METRIX Kit/RE4025-01, KINRAY TRUE METRIX Kit/RE4027-01, HEB TRUE METRIX Kit/RE4031-01, McKesson TRUE METRIX Starter Kit/RE4051-43, SUNMARK TRUE METRIX Meter Only/RE4054-00, SUNMARK TRUE METRIX Kit/RE4054-01, Signature Care TRUE METRIX Kit/RE4060-01, CareOne TRUE METRIX Kit/RE4061-01, RITE AID TRUE METRIX Kit/RE4066-01, Liberty TRUE METRIX Meter Only/RE4078-40, HUMANA TRUE METRIX Starter Kit/RE4081-03, Wegmans TRUE METRIX Kit/RE4087-01, HEALTHMART TRUE METRIX Meter Only/RE4089-00, HEALTHMART TRUE METRIX Kit/RE4089-01, ARRIVA TRUE METRIX Meter Only/RE4095-40, HealthyAccents TRUE METRIX Kit/RE4097-01, Shopko TRUE METRIX Kit/RE4098-01, Henry Schein TRUE METRIX Kit/RE4099-40, Henry Schein TRUE METRIX Meter Only/RE4099-45, Millennium Pharmay Services TRUE METRIX Kit/RE4202-43, Kroger TRUE METRIX Kit/RE4203-01, TOPCARE TRUE METRIX Kit/RE4209-01, Foster and Thrive TRUE METRIX Kit/RE4211-01, TRUE METRIX Meter Only/RE4H01-00, TRUE METRIX Kit/RE4H01-01, TRUE METRIX Starter Kit/RE4H01-04, TRUE METRIX NFRS Meter Only/RE4H01-40, TRUE METRIX NFRS Starter Kit/RE4H01-43, TRUE METRIX Kit/RE4H01-51, TRUE METRIX Meter Only (mg/dL)/RE4i01-00, TRUE METRIX Kit (mg/dL)/RE4i01-01, TRUE METRIX Kit (mg/dL)/RE4i01-02, TRUE METRIX Starter Kit (mg/dL)/RE4i03-02, TRUE METRIX Kit (mmol/L)/RE4i03-11, Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00, Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00, TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00, TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11, TRUE METRIX Kit (mg/dL)/RE4i61-02, TRUE METRIX Kit (mg/dL)/RE4i61-02THI, TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11, TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12.

The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

ALL 50 STATES
▸Full report

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

Recall #:
98317
Lot/product code:
Device Item/UDI-DI: RE4001-01/00311917166896, RE4002-01/96295126600, RE4002-40/96295126655, RE4007-01SB/50428275283, RE4011-00/87701426520, RE4011-01/87701426254, RE4019-01/713733069816, RE4023-01/21292007256, RE4025-01/93351018992, RE4027-01/21292007065, RE4031-01/41220001286, RE4051-43/20612479197231, RE4054-00/10939722447, RE4054-01/10939719447, RE4060-01/321130788669, RE4061-01/41520147745, RE4066-01/11822445610, RE4078-40/21292007614, RE4081-03/21292014797, RE4087-01/77890394113, RE4089-00/52569138557, RE4089-01/52569138526, RE4095-40/21292007041, RE4097-01/725439988933, RE4098-01/21292008901, RE4099-40/21292014902, RE4099-45/21292008697, RE4202-43/21292007454, RE4203-01/41260016028, RE4209-01/36800234529, RE4211-01/10939958693, RE4H01-00/21292006082, RE4H01-01/21292006051, RE4H01-04/21292008895, RE4H01-40/21292006068, RE4H01-43/21292006075, RE4H01-51/21292014940. International: RE4i01-00/N/A, RE4i01-01/N/A, RE4i01-02/N/A, RE4i03-02/N/A, RE4i03-11/N/A, RE4i05-00/N/A, RE4i07-00/N/A, RE4i23-00/21292010133, RE4i29-11/N/A, RE4i61-02/N/A, RE4i61-02THI/N/A, RE4i82-11/21292012205, RE4i82-12/21292009977. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX Owner's Booklet/ RE4TVH03 Rev 56 and prior, TRUE METRIX Owner's Booklet (English)/ RE4TVH35 Rev 51 and prior, TRUE METRIX Owner's Booklet (Spanish)/ RE4TVH35S Rev 51 and prior, McKesson Med Surg TRUE METRIX Self Monitoring Owners Booklet/ RE4SUN03 Rev 55 and prior, McKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior, TRUE METRIX Blood Glucose Monitoring System IFU Trividia House Brand/ RE4ITV16 Rev 53 and prior, TRUE METRIX System Instructions for Use (IFU) for Trividia Health UK Limited/RE4UKT16 Rev 55 and prior, Trividia Health LATAM - TRUE METRIX System IFU mg/dL/ RE4LAT16 Rev 50 and prior, TRUE METRIX System Instructions for Use (IFU) for Trividia Health Australia/ RE4AUT16 Rev 56 and prior. Device serial numbers: Prefix "T" followed by an eight-digit numeric sequence.
Recalling firm:
Trividia Health, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 6, 2026

Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE METRIX PRO Meter Only/RE4099P-40, Henry Schein TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01.

The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

ALL 50 STATES
▸Full report

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

Recall #:
98317
Lot/product code:
Device Item/UDI-DI: RE4H01P-40/21292006099, RE4H01P-43/21292006105, RE4212P-00/10840330705681, RE4099P-40/21292014919, RE4099P-43/21292008673, RE4051P-00/20612479197217, RE4068P-01/607415261097. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX PRO Owners Booklet/RE4TVHP03 Rev 56 and prior, McKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior, Device serial numbers: Prefix "TP" followed by a seven-digit numeric sequence.
Recalling firm:
Trividia Health, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 6, 2026

Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

Augmentation devices failed bacterial endotoxin testing.

ALL 50 STATES
▸Full report

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

Recall #:
98399
Lot/product code:
Lot: RK29976/GTIN: 00850003396248
Recalling firm:
International Life Sciences
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 6, 2026

Battery Charging Station; Model: 0998-00-0802;

The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.

ALL 50 STATES
▸Full report

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

Recall #:
98432
Lot/product code:
Model: 0998-00-0802; UDI: 10607567111964; Serial Numbers: 200019347EAI, 200019847EAI, 200019447EAI, 210018625EAI, 210017925EAI, 210017525EAI, 210018425EAI, 210020144EAI, 210020944EAI, 210022544EAI, 210020244EAI, 210022144EAI, 210020044EAI, 210020544EAI, 210021344EAI, 210023244EAI, 210018025EAI, 210019025EAI, 210021144EAI, 210021044EAI, 210022344EAI, 210019225EAI, 210019125EAI, 210018525EAI, 210022844EAI, 200017647EAI, 210019725EAI, 210022744EAI;
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 5, 2026

vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59

Not guaranteed to be germ-free

ALL 50 STATES
▸Full report

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

Recall #:
D-0336-2026
Lot/product code:
Lot # C274-000049628, Exp Date: 3-May-26.
Recalling firm:
Fresenius Kabi Compounding, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 5, 2026

vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.

Not guaranteed to be germ-free

ALL 50 STATES
▸Full report

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

Recall #:
D-0337-2026
Lot/product code:
Lot # C274-000047611, Exp Date: 10-Feb-26; Lot # C274-000049633, Exp Date: 12-May-26.
Recalling firm:
Fresenius Kabi Compounding, LLC
View official FDA record (opens in a new tab)