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

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

13601–13625 of 13802

HighFDA (Devices)·Z-1869-2021·2021-06-23
HME for Tracheostomized Patients Recalled Due to Sterilization Process Deviations
Covidien LP is recalling HME (Heat and Moisture Exchanger) units for tracheostomized patients due to potential deviations from validated ethylene oxide sterilization parameters. The recall affects 10,890 units distributed worldwide and in specific U.S. states.
Product
HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1861-2021·2021-06-23
Skytron FS32 Monitor Brackets risk structural failure and patient injury
The FS32 monitor mounting brackets may loosen and detach from their base, potentially injuring patients or staff. FDA recalls affected units.
Product
Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1894-2021·2021-06-23
Medtronic Perfusion Tubing Packs Recalled for Insufficient or Incomplete Welds
Medtronic is recalling specific lots of BB9G78R8 ECC perfusion system tubing packs due to insufficient or incomplete welds that may compromise device integrity.
Product
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2021·2021-06-23
Medtronic Custom Perfusion System Tubing Packs Recalled for Incomplete Welds
Medtronic recalls Custom Perfusion System tubing packs due to incomplete welds in the manufacturing process that may affect device integrity.
Product
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1877-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Weld Defects
Medtronic is recalling 18 tubing packs used in perfusion systems due to potentially incomplete or insufficient welds that may compromise device integrity. No injuries have been reported.
Product
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1855-2021·2021-06-23
WorkMate Claris v.1.2 Upgrade Kits Software Error Causes Function Loss
WorkMate Claris v.1.2 Upgrade Kits may lose functionality or display a black screen during operation due to a software error.
Product
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1886-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling Custom Pack HY10D90R2 sterile perfusion system tubing packs manufactured with insufficient or incomplete welds, which could compromise device integrity during use.
Product
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1851-2021·2021-06-23
Hip prosthesis components recalled for mislabeling with incorrect sizes and types
Corin TriFit hip prosthesis components from lot 467881 were mislabeled, with size 2 stems labeled as size 7 and vice versa. Surgeons could implant incorrect components during hip replacement surgery.
Product
Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled Due to Weld Defects
Medtronic recalls specific lots of HY8M63R4 Adult ECC Custom Perfusion System tubing packs due to potentially insufficient or incomplete welds, which could affect performance during surgical procedures.
Product
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1897-2021·2021-06-23
VENOVO Venous Stent System Recalled for Deployment Malfunction
The FDA is recalling VENOVO Venous Stent System units due to reports that the proximal end may fail to expand immediately upon deployment and remain connected to the delivery catheter.
Product
VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060 Venovo 10F 16/60/1200mm OUS VENEL16080 Venovo 10F 16/80/1200mm OUS VENEL16100 Venovo 10F 16/100/1200mm OUS VENEL16120 Venovo 10F 16/120/1200mm OUS VENEL16
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1898-2021·2021-06-23
VENOVO Venous Stent System 8F deployment failure during insertion
The VENOVO Venous Stent System 8F may fail to expand properly upon deployment and remain connected to the delivery system, affecting approximately 12,258 devices worldwide including 7,234 in the United States.
Product
VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/60/1200mm OUS; VENEL10080 /Venovo 8F 10/80/1200mm OUS; VENEL10100 /Venovo 8F 10/100/1200mm OUS; VENEL10120 /Venovo 8F 10/120/1200mm OUS; VEN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1866-2021·2021-06-23
Electrostatic Filter Angled recalled for sterilization validation deviations
Covidien LP is recalling Electrostatic Filter Angled devices (Item 350S19006) due to potential deviations in ethylene oxide sterilization parameters. These respiratory airway devices for anesthetized patients may not meet required sterility standards.
Product
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1878-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Weld Defects
Medtronic is recalling specific lots of CB1H18R20 Custom Perfusion System tubing packs because they may have been manufactured with insufficient or incomplete welds. No injuries have been reported.
Product
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1858-2021·2021-06-23
Medical Device Analyzer Spare Parts Recalled for Internal Clock Defect
Radiometer Medical ApS recalls E3800 PC Units spare parts due to an internal clock defect affecting analyzers. Approximately 965 units have been distributed worldwide, with 35 in the United States.
Product
E3800 PC Units (spare parts)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1853-2021·2021-06-23
WorkMate Claris Cardiac Monitoring System Software Error Causes Loss of Functionality
Abbott's WorkMate Claris cardiac monitoring system may lose functionality or display a black screen during operation due to a software error affecting 4 distributed units.
Product
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1868-2021·2021-06-23
Covidien Respiratory Filters Recalled for Sterilization Process Deviations
Covidien is recalling Adult-Pediatric Electrostatic Filter HMEs due to potential deviations in ethylene oxide sterilization parameters. Approximately 192,000 units were distributed worldwide.
Product
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1857-2021·2021-06-23
Radiometer ABL90 FLEX PLUS Analyzer Recalled Due to Internal Clock Issue
Radiometer is recalling ABL90 FLEX PLUS Analyzers with E3800 PC units due to an internal clock issue. Approximately 4,135 units are affected worldwide, including 1,277 in the United States.
Product
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1862-2021·2021-06-23
Better-Bladder ECMO Device May Collapse, Reducing Blood Flow
The Better-Bladder ECMO device used in cardiopulmonary bypass circuits may collapse during use, increasing venous line resistance and reducing blood flow. The recall affects 147 units distributed nationwide.
Product
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1893-2021·2021-06-23
Medtronic Custom Perfusion System Tubing Packs Recalled Due to Welding Defects
Medtronic is recalling 26 tubing packs from its Custom Perfusion System (Lot 221148857) due to potential manufacturing defects. Specific lots may have been manufactured with insufficient or incomplete welds.
Product
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1850-2021·2021-06-23
Hip Prosthesis Stems Mislabeled with Incorrect Size Designation
Corin Ltd is recalling TriIFit TS size 2 hip prosthesis stems that were labeled incorrectly as TriFit CF size 7 stems, and vice versa. Patients receiving mismatched implants face risk of poor fit and potential complications.
Product
Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1864-2021·2021-06-23
GE Healthcare X-Ray Systems Affected by Display Image Distortion Defect
GE Healthcare interventional x-ray imaging systems can develop a display defect that splits and distorts live monitor images into two unequal parts. The defect affects 139 devices with worldwide distribution.
Product
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1890-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling HY10L28R3 perfusion system tubing packs (lot 221679870) manufactured with insufficient or incomplete welds. The recall affects units distributed in nine U.S. states.
Product
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1859-2021·2021-06-23
Dialysate Concentrate for Hemodialysis Recalled for Out-of-Specification Formulation
Medivators, Inc. recalls 1,381 cases of dialysate concentrate due to a manufacturing anomaly that may result in out-of-specification formulation. Affected lots may not function properly in hemodialysis treatment.
Product
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling specific lots of BB10R94R6 Custom Perfusion System tubing packs due to incomplete or insufficient welds. The defect may affect device performance during use.
Product
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling specific lots of BB11J14R2 Bridge Custom Perfusion System tubing packs due to incomplete or insufficient welds that may have occurred during manufacturing.
Product
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide

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13601–13625 of 13802