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

39176–39200 of 40449

HighFDA (Devices)·Z-0531-2013·2012-12-26
Varian ARIA Radiation Oncology System Recall for DICOM Export Anomaly
Varian Medical Systems is recalling ARIA Oncology Information System units due to a software anomaly where 360-degree arc fields may convert to static fields during DICOM import or export.
Product
Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0540-2013·2012-12-26
Zimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk
Zimmer, Inc. is recalling 518 units of Persona Knee System tibial implants and tools to reduce the risk of tibial perforation and fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0579-2013·2012-12-26
DePuy Solution Calcar Stem Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.
Product
SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0597-2013·2012-12-26
Medrad Continuum MR Infusion System tubing sets recalled for flow accuracy issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0494-2013·2012-12-26
GE Healthcare Recalls Dash Patient Monitors Due to NBP Cycling Issue
GE Healthcare is recalling 119,260 Dash 3000/4000/5000 patient monitors due to a potential issue where Custom Automatic NBP Measurement cycling may stop unexpectedly.
Product
GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0578-2013·2012-12-26
DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain femoral heads.
Product
SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0603-2013·2012-12-26
Medrad Continuum MR Infusion System tubing sets recalled for flow rate issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0600-2013·2012-12-26
Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Rate Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0570-2013·2012-12-26
BD Phoenix PMIC-108 Panels Recalled for False Susceptibility Test Results
Becton Dickinson is recalling 12,250 BD Phoenix PMIC-108 panels because they may produce false intermediate or resistant antibiotic susceptibility results.
Product
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0591-2013·2012-12-26
DePuy Solution Calcar Stem Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing proper locking.
Product
SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0555-2013·2012-12-26
Zimmer Recalls Persona Knee System Tibial Sizing Plates
Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0580-2013·2012-12-26
DePuy Solution Calcar Stems Recalled Due to Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.
Product
SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0599-2013·2012-12-26
Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Accuracy Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0561-2013·2012-12-26
BioHorizons AutoTac Delivery Handle Recalled for Insufficient Cleaning Instructions
BioHorizons is recalling 174 AutoTac Delivery Handles because cleaning instructions may not remove residual contaminants after surgical use.
Product
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0595-2013·2012-12-26
Bayer Recalls Medrad Continuum MR Infusion Pump Tubing Sets
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0588-2013·2012-12-26
DePuy Solution Calcar Stems Recalled Due to Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain heads, preventing proper locking.
Product
SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0605-2013·2012-12-26
Bayer Recalls Medrad Continuum MR Infusion System Tubing Sets
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0586-2013·2012-12-26
DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may not lock properly with certain heads.
Product
SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0576-2013·2012-12-26
DePuy Solution Calcar Stem Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain femoral heads, preventing the stem and head from locking as intended.
Product
SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0582-2013·2012-12-26
DePuy Solution Calcar Stems Recalled Due to Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may not lock as intended with certain femoral heads.
Product
SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0587-2013·2012-12-26
DePuy Solution Calcar Stems Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may impinge with certain heads, preventing them from locking as intended.
Product
SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2013·2012-12-26
GE Healthcare Recalls Carescape Patient Data Module Software
GE Healthcare is recalling Carescape Patient Data Module units with v2.0 software due to two issues that may impact patient care.
Product
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and…
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-0584-2013·2012-12-26
DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing proper locking.
Product
SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0556-2013·2012-12-26
Invacare Recalls Height Adjustable Walking Canes Due to Collapse Risk
Invacare is recalling height adjustable walking canes because the height-lock button may compress unexpectedly, causing the cane to collapse and potentially injure the user.
Product
Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton. The cane is used as an aid in walking or ambulation.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0536-2013·2012-12-26
Biomet Polaris 5.5 Button Lock Screw Inserter Recalled for Hardness Defect
Ebi, LLC is recalling 15 units of Biomet Polaris 5.5 Button Lock Screw Inserters because the hardness of broken units was found to be below acceptable limits.
Product
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Category
Medical Device
Distribution
Distributed nationwide

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39176–39200 of 40449