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

39126–39150 of 40449

LowFDA (Devices)·Z-0617-2013·2013-01-09
St. Jude Medical Recalls Fast-Cath Transseptal Guiding Introducers Due to Packaging Error
St. Jude Medical is recalling 26 units of Fast-Cath Transseptal Guiding Introducers because they were packaged with a 180-degree curve instead of the labeled 90-degree curve.
Product
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0525-2013·2013-01-02
Praxair Vantage Grab n Go Gas Cylinder Pressure Regulator Recall
Praxair Inc. is recalling Vantage Grab n Go gas cylinder pressure regulators due to isolated incidents of ignition inside cylinders subjected to significant physical impact.
Product
Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0594-2013·2013-01-02
Zimmer Spine Ardis Inserter Recalled for Potential Spacer Fragmentation
Zimmer, Inc. is recalling the Spine Ardis Inserter because excessive force can break the PEEK spacer, causing sharp fragments that may damage adjacent structures.
Product
Zimmer Spine Ardis Inserter, Rx, non-sterile
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0606-2013·2013-01-02
GE T-Piece Resuscitation Circuits Recalled for Pressure Deficiency
GE Healthcare is recalling T-Piece Neonatal Patient Circuit Kits because they cannot achieve maximum Peak Inspiratory Pressure during pre-use checks.
Product
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable…
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0614-2013·2013-01-02
Roche COBAS AmpliPrep Instruments Recalled Due to Disabled Clot Detection Feature
Roche is recalling 7 COBAS AmpliPrep instruments because the sample clot detection feature was disabled during quality control, potentially allowing unflagged clotted samples to be processed.
Product
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0612-2013·2013-01-02
Beckman Coulter Recalls Access Immunoassay Systems Due to Pulley Defects
Beckman Coulter is recalling Access Immunoassay Systems because pulley drive components may break or disconnect, causing inadequate washing or mixing.
Product
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0616-2013·2013-01-02
Brookstone Recalls Heated Body Beans Due to Burn Risk
Brookstone is recalling 109,956 electrically heated body bean products nationwide due to a risk of skin burns.
Product
Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to…
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0610-2013·2013-01-02
Stryker T2 Humerus System Teflon Tube Recalled Due to Material Embrittlement
Stryker Howmedica Osteonics is recalling 100 units of the T2 Humerus System Teflon Tube because a manufacturing error caused the tube material to become embrittled.
Product
Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0611-2013·2013-01-02
Greatbatch Medical Recalls MobiCath Bi-Directional Guiding Sheaths Due to Liner Anomalies
Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths because visual inspections found loose or frayed liner material inside the device.
Product
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the…
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-0613-2013·2013-01-02
Beckman Coulter Recalls Access Total T4 Calibrators Due to Expiration Date Error
Beckman Coulter is recalling Access Total T4 Calibrators because specific lots do not meet their claimed 12-month expiration date.
Product
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0609-2013·2013-01-02
Sanofi-Aventis Recalls Diamigo Diabetes App Due to Unintended Global Access
Sanofi-Aventis is recalling the Diamigo iPhone app because it was inadvertently made available globally instead of being restricted to Brazil.
Product
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0479-2013·2013-01-02
Philips CT System Software Update Addresses Nonhazardous Reliability Issues
Philips is updating Extended Brilliance Workspace software to version 4.5.5 to fix nonhazardous reliability issues and improve system functionality.
Product
Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0615-2013·2013-01-02
Arjo Flowtron Trio DVT Pump Recalled for Lack of FDA Approval
Arjo, Inc. is recalling 2,859 Flowtron Trio DVT Pumps because they were marketed without proper FDA approval.
Product
Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0608-2013·2013-01-02
Radiometer Qualicheck 1+ Quality Control Solution Recalled for Barcode Error
Radiometer America Inc is recalling Qualicheck 1+ quality control solution due to a barcode error that incorrectly enters a pH control range into blood gas analyzers.
Product
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0548-2013·2012-12-26
Zimmer Recalls Persona Knee System Tibial Broach and Associated Tools
Zimmer, Inc. is recalling 92 units of Persona Knee System Tibial Broaches and associated tools due to a risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0574-2013·2012-12-26
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 impinge with certain heads, preventing them from locking as intended.
Product
SOL SYS F 8 CALC 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
SevereFDA (Devices)·Z-0542-2013·2012-12-26
Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk
Zimmer, Inc. is recalling Persona knee implants and associated tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0553-2013·2012-12-26
Zimmer Recalls Persona Knee System Tibial Sizing Plates
Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates due to a risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F 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
SevereFDA (Devices)·Z-0554-2013·2012-12-26
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 G Left; Size G 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
SevereFDA (Devices)·Z-0539-2013·2012-12-26
Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk
Zimmer, Inc. is recalling 318 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 SIZE C, LEFT; SIZE C RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0550-2013·2012-12-26
Zimmer Persona Tibial Sizing Plate Recalled for Perforation Risk
Zimmer, Inc. is recalling Persona Tibial Sizing Plates and related tools to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C 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
SevereFDA (Devices)·Z-0552-2013·2012-12-26
Zimmer Persona Knee System Tibial Sizing Plates Recalled for Perforation Risk
Zimmer, Inc. is recalling 188 Persona 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 E Left; Size E 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
SevereFDA (Devices)·Z-0546-2013·2012-12-26
Zimmer Recalls Persona Knee System Tibial Drill Guide
Zimmer, Inc. is recalling 94 units of the Persona Tibial Drill Guide to reduce the risk of tibial perforation and bone fracture.
Product
Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0557-2013·2012-12-26
ThyssenKrupp LEVANT Stairlifts Recalled Due to Seat Breakage Risk
ThyssenKrupp Access Corp is recalling 5,413 LEVANT stairlifts because the seat could break if the seat belt is trapped underneath the foldable part.
Product
ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up and down straight stairs, indoors and outdoors.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0514-2013·2012-12-26
Bunnell Patient Circuits Recalled Due to Heater Wire Insulation Melting
Bunnell, Inc. is recalling Patient Circuits used with the Life Pulse High Frequency Ventilator because heater wire insulation can melt, causing sparking and smoke.
Product
Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2…
Category
Medical Device
Distribution
Distributed nationwide

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39126–39150 of 40449