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 the agency’s own highest classification or reported deaths or serious injuries, 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

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

15201–15225 of 39988

ModerateFDA (Devices)·Z-1090-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, and foreign material.
Product
Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1096-2021·2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Manufacturing Defects
Cardinal Health is recalling isolation gowns and lab coats due to potential rips, holes, or foreign material that may compromise barrier protection.
Product
Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1079-2021·2021-02-17
Cardinal Health Recalls Chembloc Preparation Kits Due to Gown Defects
Cardinal Health is recalling Chembloc Preparation and Administration Kits because the included gowns may have rips, holes, or foreign material.
Product
CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1107-2021·2021-02-17
Phadia Recalls EliA dsDNA Well Kits Due to Potential False Positive Results
Phadia US Inc is recalling EliA dsDNA Well kits because decreased positive control values may cause false positive test results for systemic lupus erythematosus.
Product
EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0956-2021·2021-02-17
ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Filter Assembly Error
ICU Medical is recalling 7,500 smallbore intravascular administration sets because of an incorrect filter assembly. The affected lots were distributed nationwide and in Belgium.
Product
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1095-2021·2021-02-17
Cardinal Health Recalls Kendall Blue Isolation Gowns Due to Defects
Cardinal Health is recalling Kendall Blue Isolation Gowns due to potential rips, holes, or foreign material that may compromise barrier protection.
Product
Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1083-2021·2021-02-17
Cardinal Health Recalls ChemoPlus Chemo Prep and Admin Kits
Cardinal Health is recalling ChemoPlus Chemo Prep & Admin Kits because the included gowns may have defects like rips, holes, or foreign material.
Product
ChemoPlus" Chemo Prep & Admin Kit, CT4025
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1081-2021·2021-02-17
Cardinal Health Recalls ChemoPlus Drug Spill Kits Due to Gown Defects
Cardinal Health is recalling ChemoPlus Drug Spill Kits because the included gowns may have rips, holes, or foreign material.
Product
ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1091-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential manufacturing defects such as rips, holes, and foreign material.
Product
Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1082-2021·2021-02-17
Cardinal Health Recalls Kendall Spill Kits Due to Gown Defects
Cardinal Health is recalling Kendall Spill Kits because the included gowns may have rips, holes, or foreign material.
Product
Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1094-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential defects like rips, holes, and foreign material.
Product
Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1089-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, and foreign material that may compromise barrier protection.
Product
Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1080-2021·2021-02-17
Cardinal Health Recalls ChemoPlus Drug Spill Kits Due to Gown Defects
Cardinal Health is recalling ChemoPlus Drug Spill Kits because the included gowns may have rips, holes, or foreign material.
Product
CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1086-2021·2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes
Cardinal Health is recalling isolation gowns and lab coats because they may have rips, holes, or open seams that compromise barrier protection.
Product
Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1078-2021·2021-02-17
Cardinal Health Recalls Chemo Spill Kits Due to Gown Defects
Cardinal Health is recalling 137,346 ChemoPlus Chemo Spill Kits because the included gowns may have rips, holes, or foreign material.
Product
Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0957-2021·2021-02-17
ICU Medical Recalls MicroCLAVE Intravascular Administration Sets Due to Filter Assembly Error
ICU Medical is recalling 7,500 MicroCLAVE intravascular administration sets due to incorrect filter assembly. The affected lots were distributed nationwide in the U.S. and in Belgium.
Product
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1106-2021·2021-02-17
Arrow AGB+ Multi-Lumen CVC Kit Recalled for Labeling Error
Arrow International Inc. is recalling 1,705 kits due to a potential product code mislabeling that could cause delays or allergic reactions in sensitive patients.
Product
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1099-2021·2021-02-17
Cytocell Recalls Aquarius CRLF2 Distal Probe Due to Faint Signal Risk
Cytocell Ltd. is recalling 72 units of the Aquarius LPH 511-A CRLF2 Distal Probe Green because faint additional signals may cause normal samples to be misreported as abnormal.
Product
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1097-2021·2021-02-17
Cardinal Health Recalls Kendall Blue XXL Gowns Due to Defects
Cardinal Health is recalling Kendall Blue XXL gowns due to potential rips, holes, or foreign material that may compromise barrier protection.
Product
Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1087-2021·2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes
Cardinal Health is recalling isolation gowns and lab coats due to potential defects like rips, holes, and open seams that may compromise barrier protection.
Product
Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1092-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Defects
Cardinal Health is recalling approximately 29.8 million lab coats and gowns due to potential rips, holes, and foreign material that may compromise barrier protection.
Product
Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0946-2021·2021-02-10
Medtronic HVAD Pump Implant Kits Recalled for Startup Failures
Heartware, Inc. is recalling 19,562 Medtronic HVAD Pump Implant Kits because they may fail to start or restart at a higher rate than expected.
Product
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0925-2021·2021-02-10
Hill-Rom Liko Multirall 200 Overhead Lifts Recalled for Detachment Risk
Hill-Rom is recalling Liko Multirall 200 overhead lifts because a strap lock may not fully engage, causing the lift to detach from the rail and potentially drop the patient.
Product
Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabilitation. Affected devices: Liko Multirall 200 (product number 3130001) Universal SlingBar 450 R2R (product number 3156095) Universal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0953-2021·2021-02-10
Ethicon Dermabond Advanced Topical Skin Adhesive Recalled for Sterility Breach Risk
Ethicon is recalling Dermabond Advanced Topical Skin Adhesive because red tape in the packaging could compromise the sterile seal, potentially leading to a sterility breach.
Product
Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0945-2021·2021-02-10
Mar-Med Tourni-Cot Universal Non-Pneumatic Tourniquet Recalled for Tearing Risk
Mar-Med Co is recalling 52,000 Tourni-Cot Universal non-pneumatic tourniquets because they may tear during removal, leaving a portion in place that can constrict blood vessels and cause digit ischemia.
Product
Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.
Category
Medical Device
Distribution
Distributed nationwide

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15201–15225 of 39988