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

1–25 of 5011

SevereFDA (Devices)·Z-2993-2026·2026-09-02
Medline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
Medline is recalling neonatal and infant heated wire breathing circuits due to a risk of sporadic failure and thermal damage at the humidifier connector.
Product
Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78007K
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2991-2026·2026-09-02
Medline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Failure
Medline is recalling 20 units of neonatal heated wire breathing circuits due to potential thermal damage that could cause airway obstruction or respiratory distress in infants.
Product
Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2960-2026·2026-08-26
Tobii Dynavox Recalls TD Navio Maxi Speech Generating Devices
Tobii Dynavox is recalling TD Navio Maxi Speech Generating Devices because damaged battery tabs may cause internal short circuits, heating, and gas venting.
Product
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2976-2026·2026-08-26
Siemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Quinidine Assay because unacceptable precision may cause falsely high results, risking improper patient treatment.
Product
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2959-2026·2026-08-26
Tobii Dynavox Recalls TD Navio Midi Speech Generating Devices
Tobii Dynavox is recalling TD Navio Midi Speech Generating Devices because damaged battery tabs may cause internal short circuits, heating, and gas venting.
Product
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2975-2026·2026-08-26
Siemens Quinidine Assay Recalled for Precision Errors
Siemens is recalling 20 units of the Syva EMIT 2000 Quinidine Assay due to precision issues that may cause inaccurate test results.
Product
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2981-2026·2026-08-26
Medtronic MiniMed 670G Insulin Pumps Recalled Due to Chemical Damage Risk
Medtronic is recalling seven MiniMed 670G insulin pumps because chemical cleaning may have damaged the devices, risking incorrect insulin delivery.
Product
MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2873-2026·2026-08-19
Spectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
Spectra Medical Devices is recalling Sodium Chloride Injection ampules because manufacturing issues may have compromised sterility, posing a risk of infection or inflammation to patients.
Product
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-2922-2026·2026-08-19
Surgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA is recalling Surgipro II sutures due to potential sterile packaging defects that could cause biocontamination and infection.
Product
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2938-2026·2026-08-19
Erbe ERBECRYO 2 Cryosurgical Unit Recalled Due to Rupture Risk
Erbe USA Inc is recalling ERBECRYO 2 Cryosurgical Units because a strong pull on the high-pressure transfer hose may cause the cryoprobe to rupture.
Product
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2920-2026·2026-08-19
Dermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
Covidien is recalling Dermalon 4-0 sutures because sterile barrier packaging may be perforated or torn, risking biocontamination and infection.
Product
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
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-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-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-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-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-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-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-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-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-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-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-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-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

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1–25 of 5011