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

126–150 of 39760

ModerateFDA (Devices)·Z-2930-2026·2026-08-19
Terumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging
Terumo Medical Corporation is recalling 7,490 units of Glidesheath Slender A-Kits because they were packaged with a 0.025 guidewire instead of the specified 0.021 guidewire.
Product
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2942-2026·2026-08-19
Procedure kits with MEDICOM Ritmed Neurological Sponges are recalled due to endotoxin variability.
The FDA is recalling procedure kits containing MEDICOM Ritmed Neurological Sponges because of unexpected variability in endotoxin levels. This affects consumers who have received or plan to receive these kits.
Product
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2913-2026·2026-08-19
Ventana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies
Ventana Medical Systems is recalling navify Digital Pathology software versions 2.5 due to reported discrepancies between images and metadata in the viewer.
Product
navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) i
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2929-2026·2026-08-19
Straumann Recalls GM Helix Dental Implants Due to Labeling Mismatch
Straumann USA LLC is recalling 417 GM Helix dental implants because the implant inside the packaging may not match the outer carton label, potentially causing installation issues.
Product
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2797-2026·2026-08-12
Halyard Convenience Kits Recalled Due to Particulates in Manifolds
AVID Medical, Inc. is recalling Halyard convenience kits containing Medline Namic Angiographic Star Off Handle Manifolds because particulates may be present in the fluid path.
Product
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2796-2026·2026-08-12
Halyard convenience kits recalled due to potential particulates in manifolds
AVID Medical, Inc. is recalling Halyard convenience kits containing Medline Namic Angiographic Star Off Handle Manifolds because particulates may be present in the fluid path.
Product
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2862-2026·2026-08-12
Stryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
Stryker is recalling 46,212 units of its AHTO Tube Set Packaging (Catalog Number 0250070600) due to reported complaints of leaking from the handpiece during use. The recall affects products distributed worldwide, including US Nationwide and multiple countries.
Product
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2909-2026·2026-08-12
Blom-Singer Voice Prosthesis Boxes Mislabeled with Wrong Flange Type
Freudenberg Medical is recalling 12 Blom-Singer Classic Indwelling Voice Prosthesis devices because the boxes are mislabeled, swapping Large Esophageal Flange and Large Esophageal and Tracheal Flange contents.
Product
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2856-2026·2026-08-12
Powered Wheelchair Control Software Recall by munevo
Munevo is recalling 19 powered wheelchair hands-free control systems due to a software issue that may cause the driving mechanism to fall out of calibration, leading to unexpected steering drift or imprecise control.
Product
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2900-2026·2026-08-12
GEM Premier 5000 PAK Lysing Solution Concentration Recall
Specific lots of the GEM Premier 5000 PAK lysing bag solution have an active ingredient concentration that does not meet manufacturing specifications, which could delay recognition and management of Co-Oximetry and total bilirubin abnormalities.
Product
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2875-2026·2026-08-12
Merge OrthoPACS Imaging Workstation Recall for Patient Data Display Issue
Merge Healthcare is recalling 5 units of its Merge OrthoPACS medical imaging diagnostic workstation due to a software issue where thumbnails from a previously opened patient study may appear while a different patient study is currently open.
Product
Merge OrthoPACS, medical imaging diagnostic workstation
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2843-2026·2026-08-12
Powered Wheelchair Controller Software Recall by Pride Mobility
Pride Mobility is recalling 1,102 Q6 Edge 3 Stretto powered wheelchairs with controller software version 2.0.11 due to a defect that may cause unexpected brake stops or control system crashes.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto 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
SevereFDA (Devices)·Z-2852-2026·2026-08-12
Quantum Rehab 4Front Powered Wheelchair Controller Software Recall
Pride Mobility is recalling 1,102 Quantum Rehab 4Front powered wheelchairs with controller software version 2.0.11 due to a defect that may cause unexpected brake stops or control system crashes.
Product
Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front 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
SevereFDA (Devices)·Z-2798-2026·2026-08-12
Halyard convenience kits containing Medline Namic manifolds recalled due to particulates
AVID Medical, Inc. is recalling 5,168 Halyard convenience kits because they contain Medline Namic Angiographic Star Off Handle Manifolds that may have particulates in the fluid path.
Product
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2897-2026·2026-08-12
United Orthopedic U2 Knee Implant Bushings Recalled Over Engraving Design Issue
United Orthopedic Corp. is recalling three Femoral offset bushing components of the U2 Total Knee System due to a design issue causing incorrect engraved numbering that could lead to incorrect implant orientation during surgery.
Product
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2840-2026·2026-08-12
Radial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
Boston Scientific is recalling Radial Jaw 4 Jumbo Biopsy Forceps due to potential breach in the sterile barrier of device packaging. The recall affects 5,020 units in the US and 20,770 units outside the US.
Product
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2889-2026·2026-08-12
Beckman Coulter MicroScan Panel Update DVD Kits Recalled
Beckman Coulter is recalling MicroScan LabPro V5.03 Panel Update 11 DVD Kits due to incorrect algorithms that may affect antimicrobial susceptibility test results, potentially leading to false susceptibility classifications.
Product
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) 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 MicroScan Walk
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2876-2026·2026-08-12
GE Healthcare MAC VU360 Electrocardiograph Software Recall
GE Healthcare is recalling 163 MAC VU360 electrocardiograph units due to a software issue that may cause a previous patient's data to remain visible and be incorrectly associated with a subsequent patient.
Product
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2879-2026·2026-08-12
Boston Scientific Spinal Cord Stimulator Lead Kits Recalled
Boston Scientific is recalling INFINION CX LEAD KITs (50cm and 70cm) used in spinal cord stimulator systems due to potential lead body stress at the anchor site, which may cause lead fractures or high impedance and result in inadequate stimulation or need for additional surgery.
Product
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2854-2026·2026-08-12
Copan WASPLab Software Recall Over Results Overwrite Issue
Copan WASP is recalling WASPLab devices due to a software issue in the WebApp that may prevent users from overwriting results. The recall affects WebApp versions 2.33.1, 2.33.3, and 2.34.2.
Product
Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked w
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2891-2026·2026-08-12
Philips Allura X-Ray Systems Recalled Over Unauthorized Hard Disk Drives
Philips is recalling 5,012 Allura interventional fluoroscopic X-ray systems nationwide due to potential loss of imaging functionality, motorized movement, or data caused by unauthorized hard disk drives.
Product
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2850-2026·2026-08-12
Quantum Rehab Q6 Edge 4 Wheelchairs Recalled Due to Controller Software Issue
Pride Mobility Products Corp. is recalling Quantum Rehab Q6 Edge 4 powered wheelchairs because a software issue can cause unexpected braking and potential injury.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4 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
SevereFDA (Devices)·Z-2857-2026·2026-08-12
OXOS Medical Recalls MC2 Portable X-Ray Systems Over Circuit Board Overheating
OXOS Medical Inc is recalling 77 units of the MC2 Portable X-Ray System due to a defective circuit board that overheats. The recall affects devices distributed nationwide in FL, GA, IN, SC, TX, and VA.
Product
Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version: 5.7.0 Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2 ) is a portable and handheld x-ray system designed to aid clinicians with po
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

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126–150 of 39760