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

5776–5800 of 27393

HighFDA (Devices)·Z-1456-2024·2024-04-10
ATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling
DePuy Orthopaedics is recalling ATTUNE AFFIXIUM Cementless Fixed Bearing Knee implants (Size 6) due to incorrect labeling. The affected product includes Model No. 150621006 with Lot JA06A0252.
Product
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1450-2024·2024-04-10
Centurion Manual Uterine Dilator Surgical Kits Recalled for Weak Seal
MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.
Product
Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2024·2024-04-10
Centurion Dental Kits Recalled for Weak Seal Risk
Medline has recalled Centurion dental kits due to weak seals that may compromise sterility. No illnesses or injuries have been reported.
Product
Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1417-2024·2024-04-10
Exactech Equinoxe Reverse Shoulder Implants Recalled for Nonconforming Packaging
Exactech is recalling 826 Equinoxe Reverse Shoulder humeral liners (Item Numbers 320-36-10 and 320-36-13) due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Product
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2024·2024-04-10
Exactech Equinoxe shoulder arthroplasty glenoid components recalled for packaging defects
Exactech is recalling 35 units of Equinoxe shoulder arthroplasty glenoid components because packaging lacks required oxygen barrier protection. The components were packaged in vacuum bags without Ethylene Vinyl Alcohol (EVOH) layers.
Product
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2024·2024-04-10
Torrent Suite Dx Software versions affected by cybersecurity vulnerability
Life Technologies Corporation is recalling Torrent Suite Dx Software versions 5.14 and earlier due to a cybersecurity vulnerability that could allow unauthorized access to alter instrument settings, configurations, software, or data.
Product
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1415-2024·2024-04-10
Exactech Shoulder Implant Components Recalled for Inadequate Oxygen Barrier Packaging
Exactech Equinoxe shoulder implant components (4,007 units) are recalled because their vacuum-sealed packaging lacks a required oxygen barrier layer, potentially allowing material degradation.
Product
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Ext
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1471-2024·2024-04-10
Covidien Trocar Recall Due to Potential Seal Disengagement with Mesh
Covidien recalls 44,777 Auto Suture Blunt Tip Trocars worldwide due to potential seal disengagement when mesh products are used incorrectly with the device.
Product
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1392-2024·2024-04-10
X-Guide Handpiece Adaptor Sleeve defect affects fit on dental handpiece
The X-Guide Handpiece Adaptor Sleeve 1 may have a manufacturing defect causing incorrect geometry that prevents proper fit on dental handpieces. Approximately 88 units are affected.
Product
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1469-2024·2024-04-10
Covidien Auto Suture blunt tip trocar recalled for seal disengagement
Covidien recalls its Auto Suture blunt tip trocar (OMS-T10BTS) due to potential seal disengagement when mesh products are used incorrectly, affecting approximately 18,048 units worldwide.
Product
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1403-2024·2024-04-10
Exactech Equinoxe shoulder components recalled for nonconforming packaging
Exactech is recalling 2,008 Equinoxe shoulder implant components due to packaging that lacks a required oxygen barrier layer. The defect does not meet product specifications.
Product
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
CriticalCPSC·24179·2024-04-04
Essential Medical Supply Reannounces Adult Bed Rails Recall; Entrapment and Asphyxia
Essential Medical Supply is reannouncing a recall of approximately 272,000 Endurance® Hand Bed Rails due to entrapment and asphyxiation hazards. Two additional deaths have been reported since the original 2021 recall.
Product
Endurance® Hand Bed Rails
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1323-2024·2024-04-03
Catheter Extension Tubing Recalled Due to Identified Leachable Substances
Fresenius Medical Care is recalling 114,982 stay-safe Safe Lock Catheter Extensions due to peroxide cross-linked tubing leachables. Patients and healthcare providers are advised to discontinue use and contact the manufacturer for replacement.
Product
stay-safe /Safe Lock Catheter Ext. 12 in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1374-2024·2024-04-03
Obsidio Conformable Embolic coils recalled for bowel-ischemia risk
Boston Scientific recalled 985 Obsidio Conformable Embolic coils because using the aliquot delivery technique for lower GI bleeding poses a high risk of bowel ischemia requiring major surgery.
Product
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1327-2024·2024-04-03
FDA Recalls Fresenius Catheter Extension Tubing Due to Chemical Leachables
Fresenius Medical Care is recalling 105,700 stay-safe /Luer Catheter Extension 6 in devices nationwide due to chemical leachables identified in the peroxide cross-linked tubing. FDA classified this as a Class I recall.
Product
stay-safe /Luer Catheter Ext. 6 in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1286-2024·2024-04-03
Nimbus II Infusion Pump Systems Recalled for Multiple Potential Device Failures
InfuTronix is recalling 52,328 Nimbus II Infusion Pump Systems due to potential failure modes including battery failure, system errors, drug product leakage, flow rate issues, and housing damage. The devices will no longer be available or supported after June 20, 2024.
Product
Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1325-2024·2024-04-03
Stay-safe Luer Lock catheter extension recalled for chemical leachables
Fresenius is recalling 663,221 stay-safe Luer Lock catheter extension units nationwide due to chemical leachables (NDL PCBAs) identified in the tubing.
Product
stay-safe /Luer Lock Catheter Ext. 12 in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1382-2024·2024-04-03
Surgical Tracecarts Recalled Due to Defective Foley Catheter Component
DeRoyal Industries is recalling 134 GeoMed Custom Tracecarts distributed in Florida that contain a recalled Foley catheter component. Affected units carry specific lot numbers with expiration dates from February 2024 through May 2025.
Product
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1324-2024·2024-04-03
FDA Recalls stay-safe Luer Lock Adapter for Chemical Leachables
The FDA is recalling approximately 828,954 stay-safe Luer Lock Adapters due to chemical leachables identified in the peroxide cross-linked tubing. The nationwide recall affects all lots of Model Number 050-95003.
Product
stay-safe /Luer Lock Adapter 4 in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1302-2024·2024-04-03
Boston Scientific steerable sheath devices recalled due to manufacturing defect risk
Boston Scientific is recalling 461 POLARSHEATH Steerable Sheath devices due to a manufacturing tooling error that may cause inner sheath delamination and potential fragment release during medical procedures.
Product
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1326-2024·2024-04-03
Catheter Extension Recalled by Fresenius Due to Chemical Leachables
Fresenius is recalling 479,978 stay-safe Luer Lock Catheter Extensions due to chemical leachables in the tubing. Healthcare providers should contact the manufacturer for replacement information.
Product
stay-safe /Luer Lock Catheter Ext. 18 in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1285-2024·2024-04-03
Nimbus Ambulatory Infusion Pump recalled due to multiple failure modes
InfuTronix is recalling Nimbus Infusion Pump Systems (Nimbus Flex, Nimbus PainPro) due to potential battery failure, system errors, drug leakage, flow rate abnormalities, and housing damage. About 52,328 units are affected nationwide.
Product
Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1372-2024·2024-04-03
Laboratory performance verifier recalled for mismatched diluent assembly
Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control test results.
Product
VITROS Performance Verifier I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1389-2024·2024-04-03
Epix Universal Clip Applier Recalled for Clip Load Failure Risk
Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load a clip after the trigger is actuated, potentially impacting surgical procedures.
Product
Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - H¿PATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1371-2024·2024-04-03
Aptima CMV Quant Assay Recalled for Invalid Results with Plasma Specimens
Hologic is recalling 684 kits of the Aptima CMV Quant Assay diagnostic test; when used with plasma specimens, the assay may generate error codes that invalidate test results. Lot number 402941 is affected.
Product
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Recons
Category
Medical Device
Distribution
Distributed nationwide

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5776–5800 of 27393