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

151–175 of 39884

HighFDA (Devices)·Z-2883-2026·2026-08-12
Knee Prosthesis Trial Recall for Manufacturing Defect
United Orthopedic Corp. recalls U2 Total Knee System PSA Box Trial due to a manufacturing defect in a component screw that prevents proper assembly of the stem trial.
Product
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2836-2026·2026-08-12
FORWARD Oral Airway Kit Recall for Potential Airway Obstruction
Integrated Medcraft LLC recalls FORWARD Oral Airway Kits due to potential occlusion of the airway tip, which could impede breathing in medical settings.
Product
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2834-2026·2026-08-12
REMISOL Advance Software Version 2.5 Recalled for Incorrect Test Result Reporting
Beckman Coulter Biomedical GmbH is recalling REMISOL Advance Software Version 2.5 because it may incorrectly report combo assay test outcomes.
Product
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2877-2026·2026-08-12
FilmArray NGDS Warrior Panel Diagnostic Test Recalled Due to Strain Mismatch
Biofire Defense is recalling FilmArray NGDS Warrior Panel kits because the test may not correctly identify certain outbreak strains due to mismatches with the reference strain used during development.
Product
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2884-2026·2026-08-12
USTAR II Knee System Hinge Box Trial Recall
United Orthopedic Corp. is recalling USTAR II Knee System Hinge Box Trials due to a manufacturing defect that could prevent proper assembly of the stem trial component.
Product
Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2885-2026·2026-08-12
U2 Total Knee System Femoral Valgus Adaptor Recall
United Orthopedic Corp. is recalling its U2 Total Knee System femoral valgus adaptors due to a manufacturing defect that prevents proper assembly of the stem component during surgery.
Product
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2893-2026·2026-08-12
Philips Fluoroscopy System Recall Over Hard Disk Drive Issue
Philips is recalling 257 Allura/Centron interventional fluoroscopic X-ray systems due to potential loss of imaging, motorized movement, or data caused by unauthorized hard disk drives.
Product
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2888-2026·2026-08-12
MicroScan LabPro V5.03 Panel Update 11 analyzers recalled for incorrect algorithms affecting test results
The FDA is recalling MicroScan LabPro V5.03 Panel Update 11 electronic analyzers because their algorithms may produce inaccurate antimicrobial susceptibility test results.
Product
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2845-2026·2026-08-12
Powered Wheelchair Controller Software May Cause Unexpected Brake Stop
Pride Mobility is recalling 1,102 Q6 Edge HD powered wheelchairs due to a software issue in the controller that may cause unexpected park brake stops or system crashes when reminder pop-ups appear during use.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2858-2026·2026-08-12
Medical Action Industries Recalls Dialysis Change Tray Kits Due to Seal Defect
Medical Action Industries is recalling 3,740 Dialysis Change Tray Clear Sequence kits because the needle-free access device may have an improper seal.
Product
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2906-2026·2026-08-12
COAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
TISSIUM SA recalls COAPTIUM CONNECT nerve repair devices due to unvalidated 36-month shelf life labeling. Revised 26-month label will be applied. Device breakage beyond validated shelf life may require revision surgery.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2849-2026·2026-08-12
Quantum Rehab Q6 Edge 3 Powered Wheelchair Controller Recalled for Unexpected Braking
Pride Mobility Products Corp. is recalling the Quantum Rehab Q6 Edge 3 powered wheelchair controller due to a software issue that can cause unexpected braking and potential injury.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2842-2026·2026-08-12
Quantum Outback Powered Wheelchair Controller Recalled Due to Unexpected Braking Risk
Pride Mobility Products Corp. is recalling Quantum Outback powered wheelchairs due to a software issue that may cause unexpected braking and potential injury.
Product
Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum Outback Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2865-2026·2026-08-12
Stryker Single Spike Tube Set Recalled for Leaking During Use
Stryker is recalling 11,857 Single Spike Tube Sets due to reports of leaking from the handpiece during use.
Product
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2855-2026·2026-08-12
Nerivio Infinity Device Recall Over Battery Thermal Runaway Risk
Theranica is recalling 11,886 Nerivio Infinity devices due to a potential battery thermal-runaway event during charging that may produce smoke and odor.
Product
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2907-2026·2026-08-12
Coaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling Coaptium Connect nerve repair devices because the current 36-month shelf life is not supported by real-time data. The shelf life is being reduced to 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2859-2026·2026-08-12
Anti-Torque Instrument in Vector Pedicle Screw System Recalled
Innovasis, Inc is recalling 5 Anti-Torque instruments (part LS-749) in the Vector Pedicle Screw System due to an undersized condition that may prevent proper engagement during spinal surgery, causing delays.
Product
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2839-2026·2026-08-12
Biopsy Forceps Recall: Sterile Packaging Breach Risk
Boston Scientific is recalling Radial Jaw 4 Large Capacity Biopsy Forceps due to a potential breach in the sterile barrier of device packaging, which could compromise sterility.
Product
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2864-2026·2026-08-12
Stryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
Stryker Corporation is recalling 2,739 units of the Ahto Dual Spike Tube Set packaging due to reported handpiece leaks during use. No injuries have been reported.
Product
STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2863-2026·2026-08-12
Stryker Ahto Tube Set Recalled for Handpiece Leaking During Use
Stryker is recalling 41,052 Ahto Tube Sets worldwide due to reports of handpiece leaking during use.
Product
STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2874-2026·2026-08-12
Merge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error
Merge Healthcare is recalling 53 Merge PACS medical imaging workstations due to a software issue where thumbnails from one patient's study may incorrectly display when viewing a different patient's study, potentially compromising patient confidentiality.
Product
Merge PACS, medical imaging diagnostic workstation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2844-2026·2026-08-12
Quantum Rehab R-TRAK Powered Wheelchair Controller Recalled Due to Software Issue
Pride Mobility Products Corp. is recalling Quantum Rehab R-TRAK powered wheelchairs due to a software issue that can cause unexpected braking or system crashes.
Product
Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2887-2026·2026-08-12
HardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30µg (Lot 543461) because incorrect cartridges may cause inaccurate susceptibility testing results.
Product
HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2911-2026·2026-08-12
Neuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
Contego Medical, Inc is recalling Neuroguard IEP Carotid Stent and Post-Dilation Balloon Systems due to a potential filter failure issue.
Product
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2892-2026·2026-08-12
Philips Azurion interventional fluoroscopic X-ray systems recalled for potential hardware failures
Philips Azurion X-ray systems may lose imaging capability or motor functions due to unauthorized hard drives.
Product
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 7222
Category
Medical Device
Distribution
Distributed nationwide

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151–175 of 39884