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 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.
Minimum severity
Merit Medical Systems inadvertently distributed 17 Flex-Neck Catheter External Repair Kits intended for design verification testing to customers in Maryland, Michigan, Ohio, and Texas.
Coloplast is recalling certain Titan NB Infra Zero Ang 16cm inflatable penile prostheses due to thinner-than-standard pump wall thickness that could lead to premature pump failure.
Philips ProxiDiagnost R90 X-ray systems may experience electrical fires if exposed to overvoltage or power surges. The recalled systems affect 243 units distributed nationwide and globally.
Covidien, LP is recalling chromic gut absorbable sutures due to sterilization failure that may leave product unsterile, creating risk of infection or vision loss in eye surgery.
Philips DigitalDiagnost C50 ceiling suspensions may descend unexpectedly if annual preventive maintenance is not performed, potentially injuring patients and healthcare workers.
Coloplast is recalling 15 units of the Titan Touch Infr Zero Ang inflatable penile prosthesis (Lot Numbers 8849582, 8849603, 8904185) worldwide due to decreased wall thickness that may cause premature pump failure.
Solta Medical is recalling one Thermage CPT System unit that was potentially improperly tested and calibrated during manufacturing. The company is contacting the affected customer regarding corrective action.
Coloplast Manufacturing is recalling the Titan 0-Deg Scrotal 18 Cm inflatable penile prosthesis (25 units) due to decreased wall thickness that may cause premature pump failure. Patients with affected lot numbers should contact their healthcare provider.
Agilent Technologies is recalling 560 sample collection kits that were distributed with instructions for use the FDA had not approved.
Angiodynamics recalls NanoKnife 5-Probe Procedure Packs due to a programming error affecting RFID function. The probes may not be recognized by the NanoKnife generator, potentially delaying surgical procedures.
Coloplast Manufacturing recalls 20 units of Titan 0-Deg Scrotal inflatable penile prosthesis (Lot Numbers 8849601, 8849600, 8849621) with worldwide distribution. The specific reason for the recall is not specified in FDA records.
The Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen during high-concentration therapy due to accuracy deviations. The device's internal oxygen sensor may also display incorrect readings, creating a risk of oxygen under-delivery to patients.
FreeStyle Libre Reader batteries may swell, overheat, or create fire hazard. Do not use if the device is damaged, cracked, swollen, excessively hot, won't hold charge, or fails Reader Test.
Philips Respironics ventilators may deliver oxygen below required tolerance during high-concentration therapy. The FiO2 sensor may display higher readings than actual delivery, risking insufficient oxygen to patients.
Philips Respironics is recalling the Trilogy Evo Universal Portable Electric Ventilator (Model DS2000X11B) because it may deliver oxygen below the prescribed level during high-concentration oxygen therapy, potentially depriving patients of adequate oxygen.
Abbott is recalling over 1.3 million FreeStyle Libre Readers nationwide due to lithium-ion battery swelling, overheating, and fire hazards. Users should stop use if devices show damage, swelling, or excessive heat.
Philips DreamStation BiPAP and CPAP devices may experience communication failures with their cloud care management system, potentially preventing proper prescription settings from being downloaded to the device.
FreeStyle Libre Reader batteries used in glucose monitoring systems may swell, overheat, or pose a fire hazard. Users should only charge with the included cable and discontinue use if devices show damage, excessive heat, or charging problems.
Terumo is recalling CAPIOX RX15 Hollow Fiber Oxygenators due to improper bonding of the arterial thermistor, which may cause leaks at the connection port.
900 units of Maquet Cardiovascular's VASOVIEW HEMOPRO endoscopic vessel harvesting system are being recalled because some batches were not sterilized to their minimum specification, creating a potential infection risk for surgical patients.
Medtronic recalls 186,889 units of Grafton Putty demineralized bone matrix product due to potential packaging defects that could compromise sterile barrier integrity. No illnesses reported.
Stryker recalled 1,617 units of a disposable tourniquet cuff that may fail to achieve or hold pressure during surgery, potentially causing blood loss or hemorrhage.
Medtronic is recalling 37,721 units of Grafton Plus Paste surgical implant material due to potential packaging defects in the sterile pouch system that could compromise sterile barrier integrity.
Moberg is recalling 89 CNS-350 Neuromonitoring System devices due to battery leakage that can corrode the metal enclosure, potentially causing skin injury. Affected units were distributed worldwide.
Medtronic is recalling Accelerate Grafton DBF bone matrix products due to potential packaging non-conformances in the sterile pouch system that may compromise the sterile barrier. The recall affects 3,037 units distributed worldwide.