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
Argon Medical Devices is recalling One-Piece Introducer Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria. The kits were distributed nationwide and internationally.
Oscor Inc. is recalling Abiomed REF: 0052-3025 Introducer Kits for Impella heart pump due to potential leakage from the sidearm and hub region. Manufacturing issues may cause the 14Fr and 23Fr introducer sheaths to leak under the sheath cap and along hub score lines.
Abiomed is recalling Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines that may not be visible to users.
Abiomed is recalling Impella CP Introducer Kits worldwide due to potential leakage from the introducer sheath that cannot be visually detected by users. The manufacturing defect affects 1,540 units across multiple countries.
Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits containing Lidocaine HCL Injection USP 1% because the kits did not meet sterility release criteria.
Argon Medical Devices is recalling Bone Marrow Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria.
Abiomed is recalling the Impella CP Smart Assist Set due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. These manufacturing issues are not visually detectable.
Medtronic is recalling certain DLP One-Piece Pediatric Arterial Cannulas (Product Number 77010) due to complaints of loose foreign material containing trace levels of blood found in the devices.
GE HealthCare recalls certain Optima XR200/220/240amx mobile radiographic systems where safety testing may have been incomplete after column replacement. A failed counterpoise cable could cause the X-ray arm to drop on patients.
GE HealthCare is recalling certain Optima XR200/220/240amx Mobile Digital Radiographic Systems due to potential failure of the Column Safety mechanism, which could cause the X-ray arm to drop during patient exams. The issue stems from incomplete functional testing of the safety pawl after column replacement.
GE Medical Systems is recalling certain Optima XR200/220/240amx mobile radiographic systems after column replacements because functional testing of the safety pawl may not have been performed, which could allow the X-ray arm to drop and injure patients.
Orthofix U.S. LLC is recalling 19 units of Orthofix MINIRAIL orthopedic external fixation devices distributed across the US due to incorrect model labeling that could lead to surgical use of the wrong device.
Olympus is recalling the Toomey Evacuator 50cc with Adaptor (Model 188A) because some sterilization parameters in the instructions may not reliably render the devices sterile.
Olympus Corporation recalled the Toomey Evacuator 30cc with Adaptor (Model 188) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.
Boston Scientific's Rapid Refill Continuous Injection System (UPN M00566001) is being recalled because the recalled Medline Namic Angiographic Control Syringe may loosen or disconnect from the manifold, potentially causing leakage, inability to aspirate or inject, and procedure delays.
Maquet Cardiovascular is recalling Vasoview Hemopro 2 devices from Lot 3000547797 due to exposure to out-of-specification sterilization during gamma sterilization. The affected devices may not be properly sterilized.
Olympus Corporation is recalling the Glass Body for 194 Ellik Evacuator (Model 190A) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.
Elekta, Inc. is recalling Advanced Gynecological Applicators due to potential detachment of the intrauterine tube tip, which may remain inside a patient during cancer treatment.
Elekta is recalling the Geneva Brachytherapy Applicator due to a safety concern that the tip of the intrauterine tube may detach and remain inside a patient during cancer treatment.
Elekta's Fletcher CT/MR Shielded Applicator Set is recalled due to risk that the tip of the intrauterine tube may detach and remain inside a patient during gynecological brachytherapy treatment.
Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays used in knee replacement surgery because the knob on the tracking array may loosen, causing potential misalignment of the array.
Boston Scientific is recalling Intracept Access Instruments due to potential sterile barrier breach in the outer tray seal, which could introduce infection risk.
Medtronic MiniMed's 780G Insulin Pump can stop delivering insulin due to a software anomaly when paired with the Instinct sensor, potentially leading to delayed therapy and increased risk of hyperglycemia or diabetic ketoacidosis.
Siemens is recalling an A1c blood test assay (Material Number 11097536) for the Atellica CH and Atellica CI analyzers due to potential intermittent bias that could cause falsely high or low hemoglobin A1c patient results.
Biomerieux Inc is recalling VITEK 2 AST-N447 TEST KIT (Lot 0853293604) distributed internationally due to potential false resistant carbapenem and/or cephalosporin results when pouch foil fractures are present.