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
Stryker Medical is recalling ProCuity hospital beds with missing electrical safety test documentation, creating risk of electrical shock or tissue burns.
Certain Elekta Versa HD radiation therapy systems may experience uncontrolled detector arm extension due to microswitch setup issues. This recall affects 451 systems worldwide.
Thor Photomedicine is recalling 26 NovoTHOR Gen 2.5 XL red light therapy beds due to ball stud component failure that can cause the gas strut to detach, making the canopy difficult to lift.
Integra LifeSciences is recalling 1,639 units of its Cranial Access Kits because the outer packaging may split without additional external force, potentially compromising device sterility.
Heartware is updating instructional materials for the HVAD ventricular assist device to clarify when Controller Fault alarms sound and how to troubleshoot them. Updates also address component useful life instructions.
Staar Surgical recalls EVO VISIAN implantable intraocular lenses because they may not meet specifications. Patients with these implants should contact their ophthalmologist.
Wilson-Cook Medical is recalling QUANTUM TTC BILIARY BALLOON DILATORS due to nonconforming devices that may detach during use. Detachment could require endoscopic retrieval and carries a risk of bleeding.
Integra LifeSciences recalled the Integra Cranial Access Kit (160 units) due to a defect in the outer packaging that can split and compromise device sterility, creating an infection risk for neurosurgical procedures.
CardioQuip Modular Cooler-Heater units are being recalled due to a potential heating-chamber malfunction that could cause melting and burning of internal components. 125 units distributed across 15 US states are affected.
Randox is recalling RANDOX Total Bilirubin reagent because reports indicate elevated patient results when using plasma samples with this reagent.
Recall of approximately 1,019 Elekta Synergy radiation therapy systems due to potential uncontrolled extension of detector arms if the middle arm microswitch is incorrectly setup.
AURIS Health is recalling the Monarch Platform virtual bronchoscope due to potential software issues that may flip the displayed surgical image, which could impair visualization during minimally invasive procedures.
HeartWare is updating documentation for 380 HVAD cardiac assist devices to clarify Controller Fault alarm conditions and device lifetime instructions.
Elekta recalled its ELEKTA AXESSE radiation therapy system due to potential uncontrolled extension of detector arms if the microswitch is incorrectly configured. The recall affects 47 units distributed worldwide.
Siemens RAPIDPOINT 500e blood gas systems may show falsely elevated sodium readings in patients taking Perhexiline Maleate or Atomoxetine, risking misdiagnosis and inappropriate treatment of electrolyte imbalances.
Abbott is recalling specific lots of the Alinity m HCV AMP Kit due to reports of false positive results and reactive negative controls. The kit detects hepatitis C virus in blood samples.
Medtronic recalled 64,739 ICM LNQ22 LINQ II insertable cardiac monitors due to potential amplified noise or signal reduction that may interfere with heart rhythm recordings.
Edwards Lifesciences is recalling 168,014 TruWave with Vamp pressure monitoring kits due to potential flushing difficulties during setup. The recall affects devices distributed across the US and internationally.
24 Olympus EVIS EXERA III colonoscopes distributed to six states are recalled due to improperly repaired connectors that may cause image loss, decreased suction, or improper reprocessing, potentially exposing patients to contaminated equipment.
Aizu Olympus recalls 24 gastrointestinal videoscopes with improperly repaired light guide connectors. The defect may cause loss of image and suction, preventing proper device reprocessing and risking patient infection.
Aizu Olympus is recalling 24 colonoscopes with defective repairs to the light guide connector. The defect may prevent proper imaging, reduce suction, and impair device cleaning, potentially exposing patients to contamination.
PATH is recalling 28 units of SENTIERO Screening2 hearing examination devices due to potential technical distortions. The affected devices were distributed in Florida, Missouri, Ohio, and Wisconsin.
Aizu Olympus gastrointestinal videoscopes (GIF-H190) may have defective repairs that prevent proper sterilization, risking patient exposure to contaminated material. Affected units were distributed to medical facilities in six states.
Intuitive Surgical is recalling 317 units of a Da Vinci Single-Site Wristed Needle Driver due to potential dislodgement or breakage that could result in uncontrollable movement.
BD Insyte Autoguard BC IV catheters may have needles that fail to retract properly, potentially causing contaminated needlestick injuries, blood leakage, and repeated insertion attempts.