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
C.R. Bard is recalling 457 Sensica Urine Output System units nationwide due to complaints about urine output measurement accuracy.
Wright Medical is recalling 35 units of the Stryker INFINITY Resect Guide for INBONE Talus (Model #33620254) due to incorrect color coding. The color coding error could lead to misidentification and improper use during ankle surgery.
The ProudP Everyday Uroflow Tracker app may record lower-than-actual urination measurements when a hearing aid or AirPods Live Listen feature is active on the same iPhone, due to interference with the app's sound-based measurement system.
Davol HydroSurg Plus Laparoscopic Irrigators cannot provide irrigation. The FDA issued a Class II recall affecting 4,780 units worldwide.
Haemonetics' TEG5000 Analyzer displays incorrect PlateletMapping assay values when connected to TEG Manager Software versions 1.1–4.3.1, potentially affecting laboratory test interpretation.
GE Healthcare recalls backup batteries for anesthesia devices worldwide that may fail earlier than expected. The batteries are used in Avance CS2, Avance, Amingo, and Aespire View systems.
K2M Inc. is recalling certain Yukon Straight Rod spinal implants due to discoloration from trace amounts of inorganic phosphorous compound. The contaminated devices may cause mild irritation or adverse tissue reactions.
The Alphenix 4D CT system may fail to operate due to a system error that activates an interlock restriction. Six affected systems were distributed to hospitals in five U.S. states.
Baxter Healthcare Corporation is recalling MAC laryngoscope devices due to a packaging error. The recall affects 99 units distributed worldwide.
Volcano Corp is recalling 7,520 units of the Volcano Visions PV. 035 Digital IVUS Catheter due to missing contraindication information in the instructions for use. The IFU lacks details about situations where the device should not be used.
Volcano Corp is recalling Visions PV. 035 Digital IVUS Catheters because instructions for use do not include contraindications information. Healthcare providers should contact the manufacturer for complete safety documentation before use.
Fresenius Medical Care is recalling 19 cases of Optiflux 200NRe dialyzers distributed in Pennsylvania after exposure to cold temperatures outside safe storage ranges. Affected lot number is 22AU04017.
Getinge Flow-e Anesthesia System units may have a crack forming on the suction unit's on/off switch, which could break and prevent the suction from being activated, potentially harming patients.
Smiths Medical is recalling multiple Medfusion Syringe Pump models due to software and hardware defects that may interrupt drug infusion or cause over-infusion. Approximately 65,093 units distributed worldwide are affected.
Getinge is recalling 17 Flow-c Anesthesia Systems due to cracks that may develop on the suction unit's on/off switch, potentially preventing the switch from activating and posing a risk to patients.
Medtronic is recalling HeartWare HVAD batteries (Model 1650DE) due to an internal weld defect that can cause battery malfunction and prevent proper charging. Approximately 429 affected batteries were distributed worldwide.
Smiths Medical recalled 58,671 Medfusion Syringe Pump units worldwide due to multiple failures that could interrupt therapy or cause over-infusion, including defective alarms and display errors.
Olympus is recalling 8 EVIS EXERA II gastrointestinal videoscopes (Model GIF-HQ190) because an incorrect rubber component may have been installed during repair. The incorrect part does not meet the device's design specifications.
CardioTek EP-TRACER Software V2.x is recalled because it failed electrical safety testing for insulation. The 146 affected units were distributed worldwide.
Alcon is recalling specific lots of Clareon intraocular lenses (IOLs) due to mislabeling caused by improper manufacturing line clearance. The mislabeling resulted from partial product mixing during overlapping manufacturing runs.
Olympus Corporation recalls a single colonovideoscope model CF-H180AL because an incorrect camera unit was installed, causing narrower viewing angle and potential device protrusion that could injure tissue. No injuries have been reported.
New Standard Device Inc is recalling 14 Metalogix Slotted 90 Tubular Wrenches (Lot A29618A) due to a manufacturing error that causes the wrench to strip nuts when torqueing. No injuries have been reported.
Maquet Cardiovascular recalls INTERGARD Woven Vascular Grafts with incorrect labeling. Units labeled as 8 mm diameter instead contained 32 mm diameter grafts.
Beaver Visitec International recalled 660 units of BVI Wet-Field Eraser surgical devices after discovering boxes labeled with one tip configuration contained a different tip design. This mismatch could affect surgical precision and hemostasis control.
Bard Peripheral Vascular Inc is recalling certain catheter drainage kits that may contain an 8 Fr needle instead of the correct 6 Fr needle. The incorrect needle size could cause tissue injury during patient care.