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 the agency’s own highest classification or reported deaths or serious injuries, 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

17401–17425 of 27505

HighFDA (Devices)·Z-2735-2018·2018-08-15
Boston Scientific Guider Softip XF Guide Catheter Recalled for Polymer Degradation
Boston Scientific is recalling Guider Softip XF Guide Catheters due to potential polymer material degradation. The recall affects 31,005 units distributed in the US and Canada.
Product
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2696-2018·2018-08-15
Howmedica Recalls Radio Capitellum Small Orthopedic Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 121 Radio Capitellum Small, Right orthopedic implants because literature reviews indicate a higher revision rate than expected.
Product
Radio Capitellum Small, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2672-2018·2018-08-15
Howmedica Recalls Radial Head Implant Due to Higher Revision Rate
Howmedica Osteonics Corp. is recalling 690 Lateral Assembly, Radial Head Implant, Size 3 units because literature indicates a higher revision rate than other similar devices.
Product
Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2722-2018·2018-08-15
Howmedica Recalls Stryker Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 607 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
radial head implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2701-2018·2018-08-15
Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 225 Radio Capitellum, Recon Head, Size #3 orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Radio Capitellum, Recon Head, Size #3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2715-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate Concerns
Howmedica Osteonics Corp. is recalling 90 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2689-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 265 rHead Recon Stem Implant 6mm Collar, Size 1 units because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant 6mm Collar,Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2671-2018·2018-08-15
Howmedica Recalls Stryker Radial Head Implant Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 283 Stryker rHead Radial Head implants because literature suggests a higher revision rate than similar devices.
Product
Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2659-2018·2018-08-15
Leica M530 OHX Microscope System Recalled for Power Module Design Weakness
Leica Microsystems is recalling 123 M530 OHX Microscope Systems due to a design weakness in the power insert module.
Product
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-2679-2018·2018-08-15
Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 320 rHead Stem Implant Plasma Coated, Size 3 units because literature reviews indicate higher revision rates than other similar devices.
Product
rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2699-2018·2018-08-15
Howmedica Recalls Radial Head Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 107 Radial Head Assy Size #4 implants because literature review indicates higher revision rates than other devices.
Product
Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2684-2018·2018-08-15
Howmedica Recalls rHead Stem Implant 6mm Collar Size 4
Howmedica Osteonics Corp. is recalling 256 units of the rHead Stem Implant 6mm Collar, Size 4, because the revision rate is higher than other similar devices.
Product
rHead Stem Implant 6mm Collar, Size 4.Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2718-2018·2018-08-15
Howmedica Recalls Stryker rHead Radial Head Bipolar Stem Implants
Howmedica Osteonics Corp. is recalling 673 units of #3 Bipolar stem implants used in the Stryker rHead system due to a higher-than-expected revision rate.
Product
#3 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2669-2018·2018-08-15
Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 230 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Product
Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2693-2018·2018-08-15
Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Revision Rate
Howmedica Osteonics Corp. is recalling 170 Radio Capitellum Large, Left orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2680-2018·2018-08-15
Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 301 rHead Stem Implant Plasma Coated, Size 4 units because literature reviews indicate higher revision rates than other similar devices.
Product
rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2670-2018·2018-08-15
Howmedica Radial Head Implant Recall Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 175 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Product
Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2691-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 298 units of the rHead Recon Stem Implant 6mm Collar, Size 3, because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2711-2018·2018-08-15
Howmedica Recalls 605 Bipolar Radial Head Implants Due to Revision Rate
Howmedica Osteonics Corp. is recalling 605 sterile bipolar radial head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
#2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2687-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rate
Howmedica Osteonics Corp. is recalling 396 rHead Recon Stem Implant Plasma Coated, Size 3 units because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2604-2018·2018-08-15
New Era Orthopaedics Recalls Modera Pedicle Screw Shank Insertion Instrument
New Era Orthopaedics is recalling 6 shank insertion instruments for the Modera Modular Pedicle Screw System due to a laser weld failure reported after excessive force was applied.
Product
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2702-2018·2018-08-15
Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 124 Radio Capitellum, Recon Head, Size #4 orthopedic implants because the revision rate is higher than other similar devices.
Product
Radio Capitellum, Recon Head, Size #4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2700-2018·2018-08-15
Howmedica Recalls 163 Orthopedic Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 163 Radio Capitellum, Recon Head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2732-2018·2018-08-15
Howmedica Recalls rHead Radial Implant Due to Higher Revision Rate
Howmedica Osteonics Corp. is recalling 286 units of the rHead Radial Implant 6 mm Collar, Size 4, because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead, Radial Implant 6 mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2728-2018·2018-08-15
Howmedica Recalls 180 Radial Stem Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 180 sterile-packed radial stem implants because literature reviews indicate a higher revision rate than other similar devices.
Product
radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

17401–17425 of 27505