The Recall Desk

Hazard

Product Integrity recalls

24 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
24
Critical
0
Severe
1
Most recent
2026-08-12

Of the 24 product integrity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (4%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all product integrity recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–24 of 24

  • HighFDA (Devices)·Z-2858-2026·2026-08-12

    Medical Action Industries Recalls Dialysis Change Tray Kits Due to Seal Defect

    Medical Action Industries is recalling 3,740 Dialysis Change Tray Clear Sequence kits because the needle-free access device may have an improper seal.

    Product
    Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2025·2024-11-20

    IV Fluid Container Bags Recalled for Potential Leaks During Filling

    The Metrix Company is recalling SECURE 250 mL IV fluid containers due to leaks found during filling. Affected units were distributed nationwide and to Canada.

    Product
    SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1311-2024·2024-03-27

    Sekisui OSOM BVBLUE Bacterial Vaginosis Control Kit recalled due to temperature exposure

    A Sekisui Diagnostics control kit for bacterial vaginosis testing was recalled after exposure to temperatures below the validated storage range for up to 60 minutes due to refrigerator mechanical failure.

    Product
    Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1755-2022·2022-09-28

    BD MaxGuard Flow Controller Extension Set recalled for mislabeled expiration dates

    CAREFUSION is recalling BD MaxGuard Flow Controller Extension Sets because product labels show expiration year 2027 instead of 2025. Using expired sets risks product integrity failure and potential patient infection.

    Product
    BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Drugs)·D-0258-2022·2021-12-01

    Diclofenac Sodium Topical Solution recalled for defective container

    Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP 1.5% w/w due to a defective container. The recall affects approximately 2,664 bottles distributed nationwide.

    Product
    Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0720-2021·2021-08-18

    Zyprexa Intramuscular Injection Recalled for Manufacturing Defects

    Eli Lilly is recalling 36,540 vials of Zyprexa (olanzapine) 10 mg intramuscular injection due to manufacturing deviations affecting the drug product's appearance, size, and color.

    Product
    Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0604-2021·2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recall for Temperature Exposure

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose (5000 mL bags, 2-pack) due to temperature abuse during storage or transport that may have compromised product integrity.

    Product
    DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2326-2019·2019-08-28

    BD MAX Reagent Extraction Tubes Recalled for Improper Sealing

    Becton Dickinson is recalling BD MAX Reagent extraction tubes because foil bags may not be sealed properly, potentially compromising product integrity.

    Product
    Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2323-2019·2019-08-28

    BD Max ExK DNA 1 USA Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling 115 units of BD Max ExK DNA 1 USA kits because foil bags containing extraction tubes may not be sealed properly.

    Product
    Kit BD Max ExK DNA 1 USA; Catalog # 442817
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2334-2019·2019-08-28

    BD Max MRSA XT Extraction Tube Sealing Defect Recall

    Becton Dickinson is recalling BD Max MRSA XT kits because foil bags containing extraction tubes may not have been sealed properly.

    Product
    Kit BD Max MRSA XT; Catalog # 443461
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-1090-2019·2019-04-17

    Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure

    Integra Limited is recalling 232 units of bioBLOCK Resorbable Subtalar Implants because temperature indicators suggest exposure to temperatures greater than 110°F.

    Product
    Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2423-2018·2018-07-18

    Anika Hyalomatrix Wound Dressings Recalled for Packaging Degradation

    Anika Therapeutics is recalling Hyalomatrix wound dressings because PVC in the packaging degraded during sterilization, potentially compromising product integrity.

    Product
    Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2164-2018·2018-06-20

    BioMérieux Recalls VITEK 2 Gram-Positive Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Gram-Positive identification cards in Guadeloupe because a shipment experienced a temperature excursion exceeding acceptable limits.

    Product
    The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES A microorga
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2166-2018·2018-06-20

    BioMerieux VITEK 2 ANC Card Recalled Due to Temperature Excursion

    BioMerieux is recalling VITEK 2 ANC identification cards shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

    Product
    The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3124-2017·2017-09-20

    Leica Biosystems Recalls Napsin A Antibody Due to Temperature Excursion

    Leica Biosystems Richmond Inc. is recalling 33 units of Napsin A (MRQ-60 Mab.) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.

    Product
    Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1353-2015·2015-04-08

    Stryker Recalls Vitagel Surgical Hemostat Due to Cold Chain Violations

    Stryker Orthobiologics is recalling Vitagel surgical hemostat shipments that were not delivered within validated timeframes, potentially compromising the product's required cold storage.

    Product
    Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2527-2014·2014-10-08

    Goya Red Kidney Beans Recalled for Possible Can Seam Defect

    Tradewind Foods de Puerto Rico Inc. is recalling Goya Red Kidney Beans due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Red Kidney Beans Habichuelas Coloradas 15.5 oz. (439 g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-2528-2014·2014-10-08

    Goya Pinto Beans Recalled for Possible Can Seam Defect

    Tradewind Foods de Puerto Rico Inc. is recalling Goya Pinto Beans due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Pinto Beans Habichuelas Pintas 15.5 oz. (439g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2197-2013·2013-09-25

    Assuramed Recalls Hemoccult II SENSA elite Fecal Occult Blood Test Kits

    Assuramed is recalling Hemoccult II SENSA elite test kits because they may have been stored at temperatures outside required conditions.

    Product
    Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2013·2013-08-14

    Hospira Recalls Blood Sets Due to Potential Bag Puncture Risk

    Hospira is recalling specific blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-249-2013·2013-04-24

    Teva Recalls Copaxone Syringes Due to Visible Silicone Oil Presence

    Teva Pharmaceuticals is recalling 6,692 boxes of Copaxone (glatiramer acetate) injection due to visible medical grade silicone oil in the syringes.

    Product
    COPAXONE — COPAXONE (GLATIRAMER ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-188-2013·2013-03-13

    Aaron Industries Recalls Wal-Mart Equate Tussin CF Due to Precipitate

    Aaron Industries is recalling Wal-Mart Equate Tussin CF bottles containing a white precipitate. The substance is confirmed as guaifenesin, an active ingredient.

    Product
    Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.
    Category
    Drug
    Distribution
    Distributed nationwide