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
Boston Scientific ALTRUA 2 DR Pacemakers may unexpectedly enter Safety Mode during normal operation due to high battery impedance, potentially affecting device functionality.
The Welch Allyn Life 2000 Ventilator has a battery charger defect that could cause an alarm, rendering it inoperable. 187 units nationwide are affected in this FDA Class I recall.
Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.
Boston Scientific's ACCOLADE Family pacemakers, including VALITUDE CRT-P models, are recalled due to battery impedance defects that could trigger unintended Safety Mode during normal operation.
Boston Scientific is recalling ACCOLADE DR Pacemakers built before September 2018 due to risk of unintended Safety Mode activation caused by battery impedance issues. The devices may enter Safety Mode during normal telemetry operations.
Abiomed is recalling 1,560 units of the Impella RP with SmartAssist pump due to risk of optical sensor damage from device interactions. Damaged sensors may cause temporary or permanent pump malfunction.
Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.
Certain VISIONIST CRT-P pacemakers with latent high battery impedance may initiate Safety Mode unexpectedly during normal operations. Manufactured before September 2018, 156,329 units were distributed worldwide.
Mercury Medical is recalling the Neo-Tee T-Piece Resuscitator due to an undersized spring in the circuit flow controller that may prevent reaching proper pressure ranges, potentially impairing emergency ventilation.
Medline fluid delivery sets were assembled with a macro drip chamber instead of the required micro drip chamber, delivering three times more fluid per drop and risking patient fluid overload.
Baxter Healthcare is recalling 946 Welch Allyn Life2000 ventilators due to a battery charger defect that can trigger an alarm and render the device inoperable.
Trokamed GmbH is recalling an endoscopic access sheath (18 Fr., 130 mm) used in gastroenterology and urology. Rapid fluid inflow may block outflow and cause dangerous pressure buildup inside the kidney.
Trokamed's endoscopic access overtube may cause rapid pressure buildup in the kidney if inflow speed is too fast. The device can become obstructed by tissue and blood fragments, restricting outflow.
The AquaFlexFlow UF 500 Plus blood circuit may malfunction and remove excessive fluid from patients, causing a dangerous drop in blood volume. This risk is especially dangerous for pediatric patients.
Medline Fluid Delivery Sets were incorrectly assembled with macro drip chambers instead of required micro drip chambers. The macro chamber delivers three times more fluid per drop, creating a risk of dosing errors.
Trokamed GmbH is recalling an endoscopic access overtube sheath due to risk of intrarenal pressure buildup when inflow speed is too fast. No injuries reported.
Trokamed is recalling a 20 Fr. endoscopic access overtube due to risk of obstruction and dangerous kidney pressure buildup during procedures. If inflow speed is too quick, rapid fluid flow can restrict outflow and cause intrarenal pressure to accumulate.
Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Ventilation Systems due to a battery charger malfunction that triggers an alarm and renders the ventilator inoperable.
Olympus recalls the MAJ-891 endoscope forceps/irrigation plug nationwide because improper reprocessing may leave biomaterial inside the device, creating a contamination risk.
Karl Storz Endoscopy is recalling 285 units of optical biopsy and grasping forceps (REF 723400) distributed across 31 US states due to failure of manual cleaning validation, which compromises sterility assurance.
Sklar Instruments is recalling three models of ECONO STERILE medical procedure kits nationwide due to packaging issues that may breach the sterile barrier. No injuries or illnesses have been reported.
GE Healthcare recalls certain nuclear medicine systems that could have been transported without proper detector support, risking detector falls and life-threatening injury.
VITROS DGXN Slides are recalled because hemoglobin can interfere with digoxin measurement, producing artificially low results. Approximately 1,541 units were distributed in the US and internationally.
A software bug in BD Pyxis MedStation ES medication dispensing cabinets may prevent staff from locating alternate supply locations, potentially delaying patient therapy.
Sklar Instruments is recalling ECONO STERILE nail nipper and tissue nipper kits due to packaging defects that may compromise their sterile barrier. The affected kits were distributed nationwide.