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

101–125 of 27327

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-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
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-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-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-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-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-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-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-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-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
HighFDA (Devices)·Z-2860-2026·2026-08-12
Flow Anesthesia Machines Recalled for Failure to Deliver Anesthetic Agent
The FDA is recalling Flow Anesthesia Machines because events occurred where the anesthetic agent was not delivered when the vaporizer was activated, potentially causing patients to receive insufficient anesthesia.
Product
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
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-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
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-2902-2026·2026-08-12
Peripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling COAPTIUM CONNECT nerve repair devices because the 36-month shelf life is not supported by real-time data. The revised shelf life is 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2841-2026·2026-08-12
Powered wheelchair controller recalled for unexpected braking hazard
Pride Mobility Products Corp. is recalling 1,102 Quantum 4Front 2 wheelchair controllers because reminder pop-ups can trigger unexpected park brake stops while driving, causing falls or injuries.
Product
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 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-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-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-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-2869-2026·2026-08-12
Intramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
Biomet, Inc. is recalling various sizes of Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.
Product
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2837-2026·2026-08-12
Integrated Medcraft Recalls First Aid Kits with Defective Airway Tips
Integrated Medcraft is recalling specific Kingfisher Compact Individual First Aid Kits because the included Guedel airway components may have occluded tips.
Product
Kingfisher Compact Individual First Aid Kit. REF Number: 76656. 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-2899-2026·2026-08-12
GEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
Instrumentation Laboratory is recalling specific GEM Premier 7000 with iQM3 PAK lots because the lysing bag solution concentration does not meet manufacturing specifications, potentially delaying medical management.
Product
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium h
Category
Medical Device
Distribution
Distributed nationwide

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101–125 of 27327