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
Coloplast is recalling Titan Touch NB Infr Zero 18cm inflatable penile prostheses due to decreased pump wall thickness that may cause premature device failure after repeated use.
Philips CombiDiagnost R90 X-ray systems (Model Numbers 709030 and 709031) may experience electrical fire in the main cabinet if exposed to overvoltage or power surge.
Coloplast is recalling the Titan 0-Deg inflatable penile prosthesis due to decreased pump wall thickness that may cause premature device failure. The recall affects 23 units distributed worldwide.
Stryker is recalling 102 units of MAKO RESTORIS MultiCompartmental Knee tibial baseplate trials with incorrect size laser markings. Wrong markings could lead to selection of incorrect implant sizes during partial knee replacement surgery.
Coloplast is recalling Titan NB inflatable penile prostheses with reduced pump wall thickness that may cause premature pump failure during normal use.
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.
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.
Covidien recalled 3,228 units of Plain Gut Absorbable Sutures due to a sterilization defect. Unsterile sutures may cause infection or vision loss in eye surgery.
Western/Scott Fetzer is recalling 24,287 Digital VIPR oxygen delivery systems for a gauge malfunction that may display incorrect pressure readings. This could allow oxygen tanks to deplete without warning, potentially leaving users without oxygen flow.
Coloplast is recalling Titan Touch inflatable penile prostheses with reduced pump wall thickness, which could cause premature failure during use. The defect affects 8 units distributed across the US and multiple European countries.
Outset Medical is recalling 374 Tablo hemodialysis systems due to a software malfunction introduced during manufacturing. The defect causes frequent high conductivity dialysate alarms in devices distributed nationwide.
Coloplast Manufacturing is recalling Titan Touch Pump inflatable penile prostheses due to manufacturing defect causing decreased wall thickness that could lead to premature device failure.
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.
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 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.
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.
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.
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 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.
Remote Diagnostic Technologies is recalling 5,540 Tempus Pro Patient Monitors due to fluid ingress and basic safety issues identified with power supplies during internal testing.
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or maintain desired pressure during surgical setup, potentially causing operative site bleeding or hemorrhage.
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or hold pressure during initial surgical setup. This failure could allow blood to flow from the surgical site, potentially causing hemorrhage.
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.
Terumo Cardiovascular is recalling CAPIOX NX19 oxygenators with improperly bonded arterial thermistors that may leak. Eighty-four units were distributed across the US and internationally.
CooperSurgical is recalling Global Total LP embryo culture medium after discovering affected units may contain a different medium lacking the required protein source for embryo development.