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.
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 deaths or serious injuries are reported, 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.
Minimum severity
Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (Ref K12-09098C) because the catheter may experience resistance when being advanced over the guidewire during use.
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral Left Size 4 Cement prosthetic components because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.
Philips Ingenia Elition S MRI systems with MR Elastography may display incorrect voxel size settings in the default scan protocol when certain image reconstruction parameters are used, potentially leading to stiffness value errors.
DePuy Synthes is recalling 3 units of ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM due to external sterile packaging adhered to internal packaging, potentially compromising sterility.
Becton Dickinson & Co. is recalling certain lots of BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification, potentially affecting microbiologic laboratory testing.
Philips is recalling 15 units of its MR 7700 with MR Elastography upgrade due to potential stiffness value errors in MRI scans when specific image reconstruction parameters are used with the Resoundant algorithm.
Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges (Cervical Pack) due to higher-than-expected endotoxin levels that may be out-of-specification.
Becton Dickinson is recalling certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification.
Philips Achieva 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings when certain image reconstruction parameters are used together, potentially affecting diagnostic accuracy.
Depuy Synthes is recalling ATTUNE Revision Hinge Femoral components because external sterile packaging was found adhered to internal sterile packaging, potentially compromising sterility.
Philips is recalling Ingenia Elition X MRI scanners with MR Elastography due to potential errors in stiffness value measurements when specific image reconstruction parameters are used, which may cause incorrect voxel size display in the default scan protocol.
Advanced Bionics is recalling HiResolution Bionic Ear System M Zn-Air Battery Paks because the non-tamperproof battery door does not require a tool to open, violating safety standards. The issue affects 45,173 units distributed worldwide.
Philips is recalling certain MR 7700 devices with MR Elastography due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause voxel size settings to display incorrectly.
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridges due to potential imprecision in creatinine test results that could be erroneously increased or decreased.
Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.
Philips Ingenia 3.0T MRI systems with MR Elastography software may display incorrect stiffness values and voxel size settings when specific image reconstruction parameters are used, potentially affecting diagnostic accuracy.
Milestone S.R.L. is recalling Vacuum Bag SU Large non-sterile specimen containers (Model 68409SS) due to the possibility of reagent leakage from the container. The recall affects approximately 61,600 units distributed worldwide.
Merit Medical Systems is recalling the Philips Bridge Prep Kit (Lot K12-09098B) because the catheter may experience resistance when being advanced over the guidewire.
Philips is recalling the Ingenia 1.5T CX MRI machine with MR Elastography because certain image reconstruction parameters may cause stiffness value measurement errors in the default scan protocol.
Philips is recalling one unit of the SmartPath to dStream 3.0T MRI scanner with MR Elastography due to potential stiffness value calculation errors when specific image reconstruction parameters are used.
Hologic is correcting Genius Review Station displays (model CMP-01669) that were modified by users outside the FDA-cleared configuration. The devices need restoration to validated settings per the manufacturer's Operator's Manual.
Medline is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels. The affected in-market product may be out-of-specification for endotoxin.
Philips Evolution upgrade 3.0T with MR Elastography systems may produce incorrect stiffness values when specific image reconstruction parameters are used, causing voxel size settings to display smaller than intended.
Clinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to complaints of device breakage at the traction force gauge to handle joint. The recall affects 49,175 devices distributed nationwide and internationally.
Philips is recalling certain SmartPath to dStream 1.5T MR Elastography systems due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause incorrect voxel size settings in the default MRE scan protocol.