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

21801–21825 of 40175

HighFDA (Devices)·Z-0311-2019·2018-11-07
Philips Brilliance iCT SP CT Scanners Recalled for Misleading Calcium Score Reports
Philips is recalling 626 Brilliance iCT SP CT scanners because specific software versions generate confusing calcium score reports that may lead to patient mistreatment.
Product
Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0307-2019·2018-11-07
Philips CT Scanner Software Recall for Misleading Calcium Score Reports
Philips is recalling 145 CT scanners with software version 4.2.0 because the Calcium Score report may display confusing plaque analyses, potentially leading to patient mistreatment.
Product
Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0313-2019·2018-11-07
BD Max Instrument Recall for False Positive Candida Results
Becton Dickinson is recalling 49 refurbished BD Max instruments due to a confirmed trend of false positive Candida glabrata results when Trichomonas vaginalis is present.
Product
BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0305-2019·2018-11-07
Philips Brilliance iCT Scanners Recalled for Misleading Calcium Score Reports
Philips is recalling Brilliance iCT scanners because software errors create confusing calcium score reports that may lead to patient mistreatment.
Product
Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0302-2019·2018-11-07
Philips Recalls Vereos PET/CT Software Due to Image Errors
Philips Medical Systems is recalling 61 units of Vereos PET/CT software version 2.0.1 due to errors that may produce incorrect images or disrupt procedures.
Product
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0308-2019·2018-11-07
Philips Ingenuity CT Software Recall for Misleading Calcium Score Reports
Philips is recalling Ingenuity CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.
Product
Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0312-2019·2018-11-07
BD Max Instrument Reader Spare Part Recalled for False Positive Results
Becton Dickinson is recalling 23 BD Max Instrument Reader Spare Parts due to a confirmed trend of false positive Candida glabrata results.
Product
BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0295-2019·2018-11-07
Arthrex Recalls Li-ion Battery Housings for AR-400 DrillSaw Sports 400 System
Arthrex, Inc. is recalling 335 Li-ion Battery Housings for the AR-400 DrillSaw Sports 400 System because they may not provide a complete seal, allowing for potential fluid ingress.
Product
Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0285-2019·2018-11-07
Magellan LeadCare II Blood Lead Test Kit Recalled for Calibration Defect
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because a calibration defect causes all patient results to display as HIGH.
Product
Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0309-2019·2018-11-07
Philips CT Scanner Software Recall for Misleading Calcium Score Reports
Philips is recalling Ingenuity Core CT scanners with software version 4.1.6 because the Calcium Score report may display confusing plaque analyses, potentially leading to patient mistreatment.
Product
Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0292-2019·2018-11-07
CMP Industries Recalls Dental Resin Liquid Due to Foreign Material
CMP Industries is recalling specific lots of Impak Elastic Acrylic Resin Liquid because foreign material was found in the product.
Product
IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0361-2019·2018-11-07
Inpeco FlexLab and Accelerator a3600 Recalled for Missing Safety Labels
Inpeco S.A. is recalling 679 laboratory automation systems because some modules are missing safety pacemaker labels. The recall addresses a risk of pacemaker malfunction for personnel working near the equipment.
Product
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0347-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0325-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0372-2019·2018-11-07
Siemens EVO Excel CT System Recalled for Mis-Labeled Current Limit
Siemens Medical Solutions is recalling 264 EVO Excel CT systems because the external ECG power-connection current limit is mis-labeled as 1.0A instead of 0.55A.
Product
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0335-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Instruction Error
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0316-2019·2018-11-07
Cook Medical Recalls Zilver 518 Biliary Stent Due to Instruction Error
Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0332-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0331-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0334-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0333-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Instruction Error
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0326-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0357-2019·2018-11-07
Beckman Coulter iPAW Software Recall for Barcode Label Errors
Beckman Coulter is recalling iPAW 4.2.1 software due to a defect that may generate incorrect barcode IDs when printing consecutive tube labels.
Product
Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0293-2019·2018-11-07
CMP Industries Recalls Dental Acrylic Resin Due to Foreign Material
CMP Industries is recalling 40 units of Technoflux IMPAK dental acrylic resin because foreign material was found in the product.
Product
Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0296-2019·2018-11-07
BioFire FilmArray Blood Culture Identification Test Recall for False Positives
BioFire Diagnostics is recalling FilmArray Blood Culture Identification tests due to an increased risk of false positive results for Proteus when used with specific blood culture bottles.
Product
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle…
Category
Medical Device
Distribution
Distributed nationwide

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21801–21825 of 40175