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
Medtronic is recalling 173 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to incorrect labeling that prevents proper identification of inflation and deflation ports on the device manifold.
Biomet has recalled certain Compress Device Segmental Anchor Plugs (16 MM) due to metal burrs in the transverse holes. These burrs may prevent the drill or pins from passing through, potentially extending surgical time.
SunMed Holdings is recalling Ventlab AirFlow manual resuscitators nationwide due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Users should immediately discontinue use and contact the manufacturer.
Aizu Olympus sigmoidovideoscope (model PCF-S) units are being recalled due to an unvalidated channel drying process. Some repaired units returned with water in channels, risking contamination and infection.
Aizu Olympus is recalling certain colonoscope models because the channel air drying process was not validated. A small percentage of repaired units had water remaining in the channel, which could lead to infection risk.
Aizu Olympus Co., Ltd. is recalling duodenovideoscope models due to an unvalidated channel air drying process. Water remaining in the channels after repair poses a potential contamination risk that could lead to infection.
Certain lots of AVANOS BALLARD Closed Suction System for Adults were labeled as DEHP-free but contain DEHP in tubing components. These units are used for mechanical ventilation and distributed in the US and South Africa.
Biomet is recalling Compress Device Short Anchor Plugs (23 MM) due to potential metal burrs in transverse holes that may prevent proper insertion of surgical instruments, potentially extending surgery time. Distribution includes US and multiple international countries.
The FDA is recalling GEM Premier 3000 PAK cartridges manufactured by Instrumentation Laboratory because they may incorrectly report high oxygen levels in patients with low blood oxygen, potentially delaying critical treatment.
Instrumentation Laboratory recalls GEM Premier 3000 PAK blood gas analyzer cartridges due to measurement errors in low oxygen detection. The devices may falsely indicate normal oxygen levels when levels are dangerously low, potentially delaying treatment.
Aizu Olympus recalls bronchoscopes due to unvalidated air drying process. Some returned units after repair contain water in channels, creating infection risk.
Sage Products is recalling approximately 174,960 Stryker Sage PrimaFit External Urine Management Systems in three lots because a small percentage may contain tape with undeclared natural rubber latex adhesive.
Philips is recalling 68 Achieva 1.5T MRI machines due to potential gradient coil component failure that could produce smoke and fire. No injuries have been reported.
Biomet is recalling Compress Device Short Anchor Plugs (20 MM) because metal burrs in transverse holes prevent surgical instruments from passing through, potentially extending surgery time.
Biomet's Compress Device Segmental Anchor Plugs are being recalled due to metal burrs in assembly holes. The defect prevents drill pins from passing through, potentially extending surgical time during implantation procedures.
Medtronic has recalled the Mo.Ma Ultra Proximal Cerebral Protection Device due to mislabeled manifold stickers. Both sides of affected units were labeled identically, potentially causing confusion about which ports control the proximal versus distal balloons.
The FDA is recalling Alinity c Iron Reagent lots due to inaccurate results. The reagent produces falsely elevated patient iron values and may prevent proper quality control verification.
BD Alaris Pump infusion sets labeled as DEHP-free actually contain di(2-ethylhexyl) phthalate. The worldwide recall affects multiple catalog numbers distributed throughout the US and internationally.
Roche is recalling Tina-quant D-Dimer Test System kits because they produce elevated results when used with lithium-heparin plasma samples, potentially affecting diagnostic accuracy.
Aizu Olympus choleodochoscopes with unvalidated air drying processes may retain water in the channel after repair, risking microbial contamination and patient infection. Affected models: CHF-BP30, CHF-CB30L, CHF-P60.
Biomet's Compress Device Short Anchor Plugs may contain metal burrs in the transverse holes, which can prevent proper insertion of surgical tools and extend surgery time. The affected devices are distributed nationwide and internationally.
Biomet is recalling Compress Device Short Anchor Plugs (22 MM) used in orthopedic surgery because they may contain metal burrs in the transverse holes that could prevent drill or pin passage and extend surgical procedures.
Sentinel CH SpA is recalling IRON assay kits (Reference Numbers 6K95-41 and 6K95-30) that may produce falsely elevated results. Affected lots could cause inaccurate iron measurements and delays in patient test reporting.
SunMed Holdings is recalling SafeSpot manual resuscitators with integrated manometers due to a backwards leak that allows CO2 rebreathing. The defect affects multiple accessory configurations distributed nationwide.
Philips is recalling Achieva 1.5T MRI systems because the gradient coil component could fail and produce smoke or fire. The recall affects 2 units distributed worldwide.