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
Smiths Medical is recalling paraPAC Plus 310 ventilators because the patient outlet connector may loosen or detach, potentially interrupting ventilation. Approximately 11,244 units worldwide are affected.
Datascope Corp. is issuing a software correction for CARDIOSAVE RESCUE intra-aortic balloon pump devices to address risks of hemodynamic instability and failure to properly transmit clinical data worldwide.
Fresenius Kabi is recalling Ivenix Infusion System software (Version 5.9.1 and prior) due to anomalies that can cause pump malfunctions, alarms, or unresponsive screens while delivering medication, risking serious patient harm.
Datascope CARDIOSAVE Rescue IABP devices have a software defect that risks hemodynamic instability and clinical data transmission failure. A software correction is available.
Cook Biotech is recalling Biodesign Fistula Plug C-FPS-0.2-2 implants because affected units expire before their labeled expiration dates. The defect could compromise product performance.
American Contract Systems, Inc. is recalling the Bilateral Tubal Ligation Pack (Lot 2405102) due to inability to confirm proper sterilization following a chart recorder malfunction.
Karl Storz Hopkins Telescope 6 endoscopes are being recalled because the instructions for use contain reprocessing procedures not reviewed or approved by the FDA. Affected units should not be used until corrected instructions are provided.
Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.
Centinel Spine is recalling the Prodisc C SK cervical disc implant due to blue discoloration identified as foreign contamination on the inlay during assembly. The contamination was not fully evaluated in manufacturing validations.
Boston Scientific has recalled AGILE and WallFlex esophageal stent systems due to potential delivery catheter tip detachment. This defect could occur during stent deployment and affect proper stent placement.
Philips is recalling the Ingenia Elition X MRI device due to loose screws in the RF carrier assembly that could block the tabletop and delay diagnosis or cause patient anxiety.
Fujifilm mobile x-ray systems may fail to apply configured exposure settings or default to adult chest imaging parameters. This could result in inappropriate radiation exposure levels.
Boston Scientific's Wallflex and Agile esophageal stent systems are recalled due to the potential for delivery catheter tip detachment. The recall affects 146 units distributed worldwide.
Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems for potential delivery catheter tip detachment during insertion. Eighteen units were distributed worldwide including the United States.
Boston Scientific is recalling the Agile Esophageal Over-the-Wire Stent System due to potential for delivery catheter tip detachment. Seven affected units distributed worldwide are identified by lot numbers 32889020 and 33178844.
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes due to reports of anti-reflux valve breakage caused by improper use. Product labeling has been updated.
American Contract Systems is recalling Cath Lab Pack CECL02P medical kits because an inoperable chart recorder caused humidity readings to be out-of-specification, preventing confirmation that sterilization requirements were met.
GE Panda iRES infant warmers may have incomplete electrical safety testing that could cause leakage current to exceed safe limits. The company is recalling 137 units distributed in the US and internationally.
American Contract Systems recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.
American Contract Systems is recalling Nasal Sinus Pack units due to manufacturing control failures that prevent confirmation of sterilization. Affected units were distributed to multiple states.
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.
Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.
Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.
Boston Scientific recalls Wallflex FC and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment during use. Approximately 145 units are affected worldwide.