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

39901–39925 of 40356

HighFDA (Devices)·Z-2237-2012·2012-08-29
Abbott i-STAT cTnI Cartridges Recalled for Incorrectly Elevated Troponin Results
Abbott Point of Care is recalling i-STAT cTnI cartridges because they may produce incorrectly elevated cardiac troponin I results.
Product
i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2234-2012·2012-08-29
Exactech Recalls Optetrak Proximal Tibial Spacers Due to Dimensional Incompatibility
Exactech, Inc. is recalling 70 Optetrak Proximal Tibial Spacers because they are dimensionally incompatible with the Logic Tibial Tray.
Product
OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2254-2012·2012-08-29
Hitachi MRI Software Recall for Image Orientation Error
Hitachi is recalling MRI software due to a defect that may reverse the orientation of the first image in a dataset.
Product
Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2259-2012·2012-08-29
Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Software Anomaly
Beckman Coulter is recalling UniCel DxC 660i, 680i, 860i, and 880i systems because a software anomaly may cause erroneous test results.
Product
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2220-2012·2012-08-29
DePuy Altralinked Polyethylene Liners Recalled for Incorrect Size Labeling
DePuy Orthopaedics is recalling 20 Altralinked polyethylene liners because a size 52 liner was incorrectly labeled as size 54.
Product
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2258-2012·2012-08-29
Beckman Coulter Recalls UniCel DxI 600 Immunoassay Systems Due to Software Anomaly
Beckman Coulter is recalling UniCel DxI 600 Access Immunoassay Systems because a software anomaly may cause erroneous test results.
Product
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2240-2012·2012-08-29
GE OEC Recalls 9800 Fluoroscopic X-Ray Systems Due to Hard Drive Defects
GE OEC is recalling 9800 fluoroscopic x-ray systems because a replacement hard drive can cause system shutdowns, data loss, or data corruption.
Product
892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2231-2012·2012-08-29
Terumo Advanced Perfusion System 1 Serial Interface Module Recall
Terumo is recalling 34 Serial Interface Modules for the Advanced Perfusion System 1 due to reported malfunctions and smoke odor.
Product
Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2245-2012·2012-08-29
Philips CT Systems Recalled for Potential Patient Support Movement
Philips is recalling 126 CT systems because a damaged foot switch cover may cause the patient support to move unexpectedly.
Product
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2232-2012·2012-08-29
Terumo Interface Module Recall for Data Transfer Malfunctions
Terumo is recalling 232 interface modules for the CDl System 100/101 due to reported data transfer malfunctions and smoke odors.
Product
Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2226-2012·2012-08-29
Beckman Coulter DxH Slidemaker Stainer Floor Stand Recall for Sharp Edges
Beckman Coulter is recalling 41 DxH Slidemaker Stainer Floor Stands because missing vinyl caps expose sharp edges on drawer slides, posing a physical injury risk to operators.
Product
UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2012·2012-08-29
GE OEC Injection Cable Recall for Potential Erroneous Contrast Injection
GE OEC Medical Systems is recalling OEC Injection Cables due to a potential for erroneous auto-injection of contrast dye.
Product
GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2252-2012·2012-08-29
AGFA Medical Image Storage Device Recall for Data Loss Risk
AGFA Corp. is recalling IMPAC and IMPAX CV DICOMStore devices because misconfiguration may cause loss of patient data.
Product
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2242-2012·2012-08-29
Siemens EasyLink Informatic System Recalled for Quality Control Defect
Siemens Healthcare Diagnostics is recalling 637 EasyLink Informatic Systems because they may fail to flag quality control violations, potentially affecting patient result verification.
Product
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2244-2012·2012-08-29
Medtronic O-arm Imaging System Recalled for High Voltage Relay Overheating
Medtronic is recalling 17 O-arm Imaging Systems because a high voltage relay fault may cause overheating and burning.
Product
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2236-2012·2012-08-29
GE OEC InstaTrak 3500 Carts Recalled for Tipping Hazard
GE Healthcare is recalling 99 OEC InstaTrak 3500 Carts because the imaging arm may cause the cart to tip over during use.
Product
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2257-2012·2012-08-29
Beckman Coulter Recalls UniCel DxI 800 Immunoassay Systems Due to Software Anomaly
Beckman Coulter is recalling UniCel DxI 800 Access Immunoassay Systems because a software anomaly may cause erroneous test results.
Product
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2221-2012·2012-08-29
GE Healthcare Recalls OEC 8800 Mobile X-ray Systems for Linearity Defect
GE Healthcare is recalling 175 OEC 8800 Mobile Fluoroscopic X-ray Systems worldwide because they did not meet manufacturer specifications for linearity.
Product
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2249-2012·2012-08-29
Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues
Stryker is recalling 159 Powered MOV Chairs to address potential compliance issues regarding product documentation and classification identified during a merger review.
Product
Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2228-2012·2012-08-29
Siemens Syphilis Assay Recalled Due to Interference with Hepatitis B Testing
Siemens is recalling ADVIA Centaur Syphilis Assay kits because they may interfere with Hepatitis B surface antigen testing, potentially affecting diagnostic accuracy.
Product
Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2235-2012·2012-08-29
Stryker Spine Recalls Instructions for Use Due to Sterile Marking Error
Stryker Spine is recalling 40 units of Instructions For Use for TRIO+ Standard Post Screws because the front cover was incorrectly marked with a 'Sterile' logo.
Product
The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2224-2012·2012-08-29
Biomet Oxford Gap Gauge Recalled Due to Drafting Error
Biomet U.K., Ltd. is recalling 119 Oxford Gap Gauge instruments because a drafting error resulted in misleading dimensions on the product drawings.
Product
Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2225-2012·2012-08-29
Beckman Coulter DxH Slidemaker Stainer Floor Stand Recall for Sharp Edges
Beckman Coulter is recalling 41 DxH Slidemaker Stainer Floor Stands because missing vinyl caps expose sharp edges on drawer slides, posing a physical injury risk to operators.
Product
UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2248-2012·2012-08-29
Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues
Stryker is recalling 159 Powered MOV Chairs due to potential compliance issues in product documentation and classification identified during a merger review.
Product
Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2229-2012·2012-08-29
Sunquest Laboratory SMART Software Recall for Incorrect Patient Data
Sunquest Information Systems is recalling Sunquest Laboratory SMART software versions 6.4.2 due to a defect that may display incorrect patient demographic data.
Product
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Category
Medical Device
Distribution
Distributed nationwide

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39901–39925 of 40356