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.

Agency

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1–25 of 81

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
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
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-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-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
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
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
SevereFDA (Drugs)·D-0383-2019·2019-01-30
Bound Tree Medical Recalls Epi Safe Kits Due to Incorrect Instructions
Bound Tree Medical is recalling Epi Safe Administration and Training Kits because the instructions recommend an unapproved epinephrine dosage for young children.
Product
curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 1 Epi Safe Training Kit (8600-01102), Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Me
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0384-2019·2019-01-30
Recall of Curaplex Epi Safe Kits Due to Incorrect Epinephrine Instructions
Bound Tree Medical is recalling Curaplex Epi Safe Kits because the instructions recommend an unapproved epinephrine dosage for young children.
Product
curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 Adhesive Dressing " 1 Insert, Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Eme
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0801-2018·2018-05-16
Coast Quality Pharmacy Recalls MAA Kits Due to Sterility Concerns
Coast Quality Pharmacy LLC is recalling 52 vials of Macroaggregated albumin (MAA) kits due to a lack of assurance of sterility. The affected products were distributed to six states.
Product
Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL
Category
Medical Device
Distribution
6 states
SevereFDA (Drugs)·D-0377-2018·2018-02-21
Sage Products Recalls Q CARE Oral Cleansing Systems Due to Cross-Contamination
Sage Products Inc. is recalling Q CARE q4 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0393-2018·2018-02-21
Sage Q.Care Oral System Recalled for Cross-Contamination Risk
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Petit Size Suction Toothbrush packages with Antiseptic Oral Rinse, 4 Petit Size Untreated Suction Oral Swab packages with Antiseptic Oral Rinse, 2 8 French Oropha
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0376-2018·2018-02-21
Sage Q CARE Oral Cleansing System Recalled for Cross-Contamination
Sage Products Inc. is recalling Q CARE q2 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free mouthwash, 4 Oropharyngeal
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0375-2018·2018-02-21
Sage Q CARE Oral System Recalled for Cross-Contamination Risk
Sage Products is recalling Q CARE q4 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Thr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0397-2018·2018-02-21
Sage Products Recalls Q.Care Oral Cleansing Systems Due to Cross-Contamination
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.Care Oral Cleansing & Suctioning System q8. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 1 Suction Oral Swab packages with Perox-A-Mint solution, 1 Oropharyngeal Suction Catheter package. Sage Products, Inc
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0291-2018·2018-02-07
Medline Suture Removal Tray Recalled for Subpotent Povidone-Iodine
Medline Industries is recalling suture removal trays because the povidone-iodine prep pads contain less iodine than labeled.
Product
Medline Straight Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0317-2018·2018-02-07
Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling 9,000 cases of Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim.
Product
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0266-2018·2018-02-07
Medline Central Line Dressing Change Tray Kit Recalled for Subpotent Iodine
Medline is recalling Central Line Dressing Change Tray Kits because the iodine concentration in the prep pads is below the label claim.
Product
Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0270-2018·2018-02-07
Medline Wound Closure Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling 80 cases of Wound Closure Trays because the iodine concentration in the prep pads is below the labeled claim of 0.85%.
Product
Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0313-2018·2018-02-07
Medline Recalls Suture Removal Kits With Subpotent Iodine Concentration
Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the labeled claim of 0.85%.
Product
Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590
Category
Medical Device
Distribution
Distributed nationwide

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