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
The Abbott Proclaim 5 Elite implantable pulse generator may reach end of service earlier than product labeling indicates. Approximately 38,530 units are affected worldwide.
B. Braun is recalling OUTLOOK IV Sets due to potential backcheck valve malfunction that could allow medication backflow and loss. The defect may result in adverse drug reactions or medication loss.
Abbott's Proclaim 5 implantable pulse generator may reach end of service sooner than indicated in product labeling. The time between the elective replacement indicator threshold and complete device failure may be shorter than documented.
Abbott is recalling approximately 457 Proclaim 7 Implantable Pulse Generators because the battery may reach end of service sooner than indicated in labeling. Patients may require unexpected device replacement.
Abbott Proclaim XR 7 implantable pulse generators may have a shorter service life than indicated in product labeling. Approximately 9,006 units distributed worldwide are affected.
Abbott is recalling 569 units of the Proclaim 7 implantable pulse generator because the device may reach end-of-service sooner than indicated in labeling. All affected units were distributed worldwide.
Abbott recalls 1,086 Proclaim Plus 7 implantable pulse generators due to labeling inaccuracy. Devices may reach end of service sooner than labeled, potentially reducing the time patients have to plan for replacement.
SeaSpine Orthopedics is recalling the Meridian Angled Awl Fixed surgical instrument due to insufficient weld around the cap component that may fail under impaction forces during surgery.
Waldemar Link is recalling Endo Model SL Tibial Components used in knee replacement surgery because the blind screws on the modular components cannot be loosened during surgery, potentially prolonging procedures and forcing surgeons to change their planned approach.
Abbott Proclaim 5 Implantable Pulse Generators may have a shorter battery lifespan than labeled, potentially affecting replacement timing for patients.
MED-EL Mi1250 SYNCHRONY 2 cochlear implants may have cracks in their internal electronics substrate that could cause device failure. Seven devices distributed to Durham, North Carolina are affected.
Stryker is recalling 90 units of Zimmer Tourniquet Cuff 30" because packaging labels them as dual port single bladder, but they actually contain a single port single bladder configuration.
Abbott is recalling 21,843 Proclaim DRG implantable pulse generators because the duration between the device's elective replacement indicator and end of service may be shorter than stated in product labeling.
Medical Depot is recalling Nitro Glide Knee Walker Model 791BL units due to a defect where the tiller may separate from the base assembly. If the device fails, users may fall and sustain injury.
B. Braun is recalling Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY (Model 362420) IV infusion sets due to backcheck valve malfunction that can cause medication to flow backward from secondary to primary IV containers.
The Endo Model M tibial components cannot be loosened during surgery, preventing surgeons from making necessary intraoperative adjustments. This may force unplanned procedure changes.
B. Braun is recalling Infusomat 60 infusion pump sets (Model 363010) due to potential backcheck valve malfunction. The defect could cause medication to flow backward into primary IV containers and prevent proper medication delivery.
Greiner Bio-One is recalling VACUETTE blood collection tubes due to missing additive affecting clotting and separation. Defective tubes could delay patient treatment if samples require recollection.
Surgical image guidance software in NGENUITY 3D systems may miscalculate lens axis placement during eye rotation, potentially causing astigmatic error and decreased visual acuity.
B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET units due to a potential backcheck valve malfunction that could cause medication backflow and adverse drug reactions.
B. Braun is recalling Outlook IV pump sets due to potential backcheck valve malfunction that could allow medication backflow and prevent proper priming, posing a risk of adverse drug reactions and medication loss.
B. Braun Medical is recalling the Infusomat SPACE IV pump set (Model 480255) due to potential backcheck valve malfunction that could allow medication to flow backward between IV containers, potentially causing adverse drug reactions or loss of medication.
A heating defect in the Qiagen QIAcube Connect MDx may prevent proper incubation temperatures below 40°C, potentially affecting diagnostic test results.
B. Braun Medical is recalling an infusion pump set due to potential backcheck valve malfunction that could cause medication to flow backward into IV containers and prevent proper medication administration. The recall affects 3,624 units distributed worldwide.
BD Multitest 6-Color TBNK flow cytometry reagent contains contaminated antibodies that may produce erroneous or delayed test results, potentially impacting clinical decisions.