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

14351–14375 of 40151

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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1892-2021·2021-06-23
Medtronic Cardiac Perfusion Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling specific lots of BB8M63R5 adult cardiac perfusion tubing packs due to incomplete welds in the manufacturing process. These defects could compromise tubing integrity during cardiac surgery.
Product
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1856-2021·2021-06-23
Radiometer ABL90 FLEX Analyzer Recalled Due to Internal Clock Malfunction
Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with E3800 PC units due to an internal clock issue. Approximately 3,346 units are affected globally, with only 2 in the United States.
Product
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Category
Medical Device
Distribution
Distributed nationwide
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-1848-2021·2021-06-23
Surgical Angio Pack Kits Recalled Due to Incomplete Angio Tubing Weld
Windstone Medical Packaging is recalling Angio Pack surgical kits (Lot 146304 and 147534) due to angio tubing with insufficient or incomplete welds.
Product
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22…
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-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-1896-2021·2021-06-23
OSSUR Miami J Select Collar Recalled for Deforming Height-Adjustment Racks
Ossur Americas is recalling the MIAMI J SELECT COLLAR cervical spine device due to deforming racks that may reduce immobilization. About 10,469 units were distributed nationwide.
Product
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
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-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-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-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-1871-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled Due to Weld Defects
Medtronic is recalling specific lots of HY10Z48R2 Adult ECC Custom Perfusion System tubing packs due to potential weld defects. Affected units may have insufficient or incomplete welds that could compromise device function.
Product
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
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-1891-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Weld Defects
Medtronic is recalling specific lots of CB10Y89R10 custom perfusion system tubing packs due to insufficient or incomplete welds. The affected lots were distributed in nine U.S. states.
Product
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
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-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-1887-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Defective Welding
Medtronic has recalled 16 tubing packs from its CB10R79R6 Custom Perfusion System due to insufficient or incomplete welds in specific lots. The defect may compromise device integrity during use.
Product
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, 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-1895-2021·2021-06-23
Medtronic Neonatal Perfusion System Tubing Sets Recalled for Incomplete Welds
Medtronic is recalling 7 neonatal perfusion system tubing sets manufactured under lot 221387901 with insufficient or incomplete welds. The affected sets were distributed nationwide across nine states.
Product
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1876-2021·2021-06-23
Medtronic Custom Perfusion System Tubing Packs Recalled for Weld Defects
Medtronic recalls custom perfusion system tubing packs due to potential manufacturing defects in welds. Specific lots may have insufficient or incomplete welds that could affect system integrity.
Product
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, 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-1879-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Insufficient Welds
Medtronic Perfusion System tubing packs are recalled due to manufacturing defects involving insufficient or incomplete welds in the CB10W63R1 lot. Affected devices may malfunction during use.
Product
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1889-2021·2021-06-23
Medtronic perfusion system tubing packs recalled due to weld defects
Medtronic is recalling specific lots of CB7J98R7 Custom Pack perfusion system tubing because some units may have insufficient or incomplete welds. The defect could affect device performance during cardiac surgery.
Product
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

14351–14375 of 40151