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
Maquet Datascope is recalling 12,319 CS 100 Intra-Aortic Balloon Pumps because electrical and autofill failures prevented the device from initiating therapy, which has been associated with a patient death.
Maquet Datascope is recalling 12,319 CS 300 Intra-Aortic Balloon Pumps because electrical test failures caused the device to fail to pump, which has been associated with a patient death.
Maquet Datascope is recalling 12,319 CS 100i Intra-Aortic Balloon Pumps because electrical failures prevented the device from initiating therapy, which has been associated with a patient death.
Flowonix Medical is recalling Prometra II implantable infusion pumps after a report of a fatal drug overdose during an MRI procedure.
Penumbra Inc. is recalling 155 units of the 3D Revascularization Device because a raw material issue could cause the delivery wire to break, potentially leading to serious injury or death.
Abbott Vascular is recalling the Absorb Bioresorbable Vascular Scaffold (BVS) System in Australia due to studies showing higher rates of major adverse events, including myocardial infarction and scaffold thrombosis, compared to metallic stents.
Abbott Vascular is recalling NC Traveler RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.
Philips is recalling HeartStart MRx Monitor/Defibrillators because they may fail to deliver therapy or monitoring when operating on a single battery.
Physio-Control is recalling 133,330 LIFEPAK 1000 defibrillators worldwide because they may unexpectedly power off during use.
SynCardia Systems Inc. is recalling five Freedom Driver Systems because the main circuit board may fail silently, causing loss of life-sustaining function.
Micro Therapeutics Inc. is recalling 3,337 Alligator Retrieval Devices because the PTFE coating may delaminate and detach, potentially entering the bloodstream.
Micro Therapeutics Inc is recalling Pipeline Embolization Devices because PTFE coating may delaminate and enter the bloodstream.
St Jude Medical is recalling specific implantable defibrillators because a lithium cluster in the battery can cause a short circuit and premature depletion.
The Anspach Effort, Inc. is recalling Light Adaptors for Small Battery Drive and Small Battery Drive II devices due to a potential risk of bursting from excessive internal pressure.
Baxter Healthcare is recalling VASCU-GUARD Peripheral Vascular Patches due to postmarketing reports of intraoperative and postoperative bleeding, including one fatal outcome.
Heartware, Inc. is recalling 18,631 HeartWare Ventricular Assist System batteries due to premature depletion. The recall covers devices distributed nationwide in the US.
CareFusion is recalling AVEA Comprehensive ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Monteris Medical Corp is recalling 121 NeuroBlate System SideFire Select 2.2 mm Directional Laser Probes because a sapphire lens fractured during a procedure, introducing CO2 into a patient's brain.
B Braun Medical Inc is recalling 68 Dialog+ Hemodialysis Conductivity Sensors due to a potential leakage hazard. The units were distributed nationwide to various states and territories.
Mevion Medical Systems is recalling five MEVION S250 proton therapy systems because an aperture may fall out during gantry motion, posing a risk of traumatic injury or death to patients.
Vascular Solutions is recalling Guardian II Hemostasis Valves because the low-pressure seal may fail, potentially allowing air into the device and causing an air embolism.
Arrow International is recalling Percutaneous Insertion Trays because the sheath body may separate from the hub, creating a potential for bleeding.
Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Arrow International is recalling RediGuard IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.