The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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1–25 of 100

  • HighFDA (Drugs)·D-0284-2026·2026-01-21

    Heparin antibody test kits recalled over a defect producing negative results

    Diagnostica Stago is recalling 438 Asserachrom HPIA kits from one lot because a potential defect can affect every well in an impacted strip and produce negative results.

    Product
    LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0301-2025·2025-04-02

    SinuCleanse Neti Pot Nasal Wash System Recalled for Bacterial Contamination

    Ascent Consumer Products Inc. is recalling SinuCleanse Soft Tip Neti Pot Nasal Wash System due to bacterial contamination with Staphylococcus aureus. Consumers should stop using this product immediately.

    Product
    SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0247-2025·2025-03-05

    ViaMed Alcohol Prep Pads Recalled Due to Sterility and Manufacturing Issues

    Rece International Corp. is recalling ViaMed Alcohol Prep Pads due to lack of sterility assurance and manufacturing process deviations. The affected product was distributed in Florida.

    Product
    ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, N
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-1121-2022·2022-06-15

    Bone Marrow Biopsy Tray with Lidocaine Hydrochloride Recalled for Temperature Abuse

    McKesson is recalling Bone Marrow Biopsy Trays with Lidocaine due to cGMP deviations from temperature abuse. Product was distributed nationwide.

    Product
    Biopsy and Aspiration Tray Bone Marrow Illinois 11GX4 (10/cs) Rx CRFPED Lidocaine Hydrochloride USP, 1%, 5mL, Rx only, MFG: Becton Dickinson
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1010-2022·2022-06-15

    Epidural Nerve Block Tray Recalled for Temperature Abuse

    McKesson Medical-Surgical is recalling an Epidural Nerve Block Tray (model #182207) distributed nationwide due to temperature abuse during manufacturing that violates cGMP standards. The exposure may compromise device sterility required for safe epidural procedures.

    Product
    Epidural Tray, Nerve Block Single shot, Rx only, # 182207, MFG: Avanos Medical Sales LLC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1030-2022·2022-06-15

    Smiths Medical Spinal Tray Recalled Due to Manufacturing Temperature Deviations

    McKesson Medical-Surgical recalls Smiths Medical spinal trays due to manufacturing temperature deviations. Approximately 8 cases were distributed nationwide.

    Product
    Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manufacturer: Smiths Medical ASD, Inc., NJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0348-2021·2021-05-05

    ChloraPrep One-Step Recalled for Potential Fungal Growth and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to a lack of assurance of sterility. The product may allow fungal growth at labeled storage conditions, potentially breaching package integrity.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0345-2021·2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Contamination

    CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth breached package integrity under labeled storage conditions.

    Product
    ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 26040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0346-2021·2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Due to Fungal Contamination

    CareFusion is recalling ChloraPrep antiseptic applicators because fungal growth breached package integrity. The product is non-sterile, but the breach compromises the sterility of the applicators.

    Product
    ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0349-2021·2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk

    CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth may breach package integrity. The product was distributed in the US and 12 other countries.

    Product
    ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 26040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0347-2021·2021-05-05

    ChloraPrep One-Step Recalled for Potential Fungal Growth and Sterility Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to potential fungal growth that may breach package integrity and compromise sterility.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0350-2021·2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk

    CareFusion 213, LLC is recalling ChloraPrep With Tint antiseptic applicators because fungal growth may breach package integrity at labeled storage conditions.

    Product
    ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0318-2021·2021-04-07

    Ferring Recalls ZOMA-Jet 10 Demonstration Kits Due to Defective Delivery System

    Ferring Pharmaceuticals is recalling 1,569 ZOMA-Jet 10 Demonstration Kits because the injector pen may break apart and disintegrate into pieces.

    Product
    ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0317-2021·2021-04-07

    Ferring Recalls ZOMA-Jet 5 Demonstration Kits Due to Defective Delivery System

    Ferring Pharmaceuticals is recalling 301 ZOMA-Jet 5 Demonstration Kits because the injector pen may break apart and disintegrate into pieces.

    Product
    ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0267-2021·2021-03-03

    CareFusion Recalls ChloraPrep Antiseptic Applicators for Potential Fungal Contamination

    CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches in hot, humid climates.

    Product
    ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1511-2020·2020-08-26

    CareFusion Chlorhexidine Applicators Recalled for Non-Sterility

    CareFusion 213, LLC is recalling ChlroraPrep One-Step applicators due to the presence of Aspergillus Penicilloides.

    Product
    ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1510-2020·2020-08-26

    CareFusion Recalls ChloraPrep Applicators Due to Non-Sterility

    CareFusion is recalling ChloraPrep With Tint applicators because they are not sterile and contain Aspergillus Penicilloides.

    Product
    ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0454-2020·2019-11-27

    CVS Health Lubricant Gel Drops Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling CVS Health Extra Strength Lubricant Gel Drops due to a lack of assurance of sterility.

    Product
    CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2020·2019-11-27

    CVS Health Lubricating Gel Drops Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling CVS Health Lubricating Gel Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the pharmacy.

    Product
    CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0472-2020·2019-11-27

    Altaire Recalls Nano Tears Lubricant Gel Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops because the product lacks assurance of sterility.

    Product
    Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, NDC 59390-144-51
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0479-2020·2019-11-27

    Altaire Recalls Nano Tears Lubricant Gel Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling specific lots of Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops because the agency could not ensure the product was sterile.

    Product
    Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-144-51
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0338-2020·2019-11-20

    Viatrexx-Mesenchyme Recalled Due to Lack of Assurance of Sterility

    Viatrexx Bio Incorporated is recalling Viatrexx-Mesenchyme vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.

    Product
    Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0092, NDC 73069-102-41.
    Category
    Medical Device
    Distribution
    Distributed nationwide