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 is recalling 68 JAGTOME REVOLUTION RX medical devices due to sterile barrier breach. The devices were distributed worldwide including throughout the US.
Boston Scientific is recalling 472 DREAMTOME stent devices due to sterile barrier breach affecting product sterility. Devices were distributed worldwide including the US.
Bard Peripheral Vascular Inc is recalling pediatric lumbar puncture trays due to manometer leaking and mating failures that could prevent proper pressure measurement during procedures.
Boston Scientific is recalling RX Cholangiogram Kits because the sterile barrier has been breached, compromising the sterility of the devices. The affected kits were distributed worldwide.
CellEra LLC is recalling Vitale Silver calcium alginate dressings nationwide because packages contain incorrect Instructions for Use with language not approved by the FDA. The firm is providing replacement packages with corrected instructions.
CellEra LLC is recalling Vitale Silver calcium alginate wound dressings nationwide due to incorrect instructions for use containing language beyond FDA-cleared content.
Microbiologics Inc recalls LYFO Disk lot 983-40-3 because it is labeled as Candida tropicalis but actually contains Yersinia enterocolitica. The mislabeling may cause laboratory quality control failures and delayed test results.
Microbiologics Inc is recalling Mycoplasma genitalium Control Panel units that did not undergo proper release testing before distribution. Affected lots were distributed across the U.S. and internationally.
LivaNova is recalling four Sorin Centrifugal Pump CP5 Drive Units because a ferrite ring on the power cable may be missing. The units were distributed in Florida, Texas, and Nebraska.
CellEra LLC recalls Vitale Silver calcium Alginate Dressing Ropes due to incorrect Instructions for Use in product packaging. The manufacturer is replacing affected units with corrected instructions.
CellEra LLC is recalling Vitale Silver calcium Alginate Dressings because product packages contain incorrect Instructions for Use with language beyond FDA 510(k) clearance scope. The firm is replacing affected units with correct instructions.
CellEra LLC is recalling Vitale Silver calcium alginate dressings because the included Instructions for Use contain language exceeding FDA clearance. The firm is replacing affected units with correct instructions.
Lusys Laboratories' Luscient Diagnostics COVID-19 Antigen Test Kits are being recalled because they lack FDA authorization. The kits were not approved, cleared, or authorized for distribution in the United States.
Lusys Laboratories is recalling 14,745 kits of COVID-19 antigen test kits that lack FDA clearance, approval, or emergency use authorization. The kits were distributed nationwide and internationally without required regulatory validation.
The Medtronic TurboHawk Plus Directional Atherectomy System (catalog THP-S) is being recalled due to design similarities to another device that experienced tip detachment and embolization. The recall affects 245 devices distributed nationwide.
ev3 Inc. is recalling the Medtronic TurboHawk Plus Directional Atherectomy System due to design similarities to a device with reported tip detachment and embolization incidents. The FDA has classified this as a Class I recall.
Lusys Laboratories is recalling 33,955 COVID-19 antibody test kits distributed across the US and internationally because the product lacks FDA authorization, clearance, or approval for marketing or use.
The Nextra Cannulated Hammertoe Standard Instrument Kit's driver may deform the implant locking mechanism during insertion, potentially requiring revision surgery.
ExacTrac Dynamic radiotherapy positioning software (versions 1.0.0–1.0.3) may calculate incorrect yaw angle for patient positioning with Varian linear accelerators, potentially affecting cone-beam CT imaging setup accuracy during radiotherapy.
Proton therapy systems from Ion Beam Applications may not verify that beam range settings remain unchanged after treatment pause, risking incorrect treatment delivery if the range was manually modified.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry VersaTips due to shape deformity that may reduce sample volume by 16%. Undetected errors could result in inaccurate test results for bloodborne infectious disease assays.
A vascular graft has been recalled due to labeling mismatch: the outer package label differs from the inner sterile packaging in graft type and dimensions. Implanting the wrong size could disrupt blood vessel connections and create a pseudo-aneurysm.
NeuMoDx COVID-19 test strips (Lot 116305 S/L-02) are recalled due to product contamination that increases risk of false positive results. The recall affects 102 boxes distributed in FL, MD, MI, and NY.
Nextremity Solutions recalls the Nextra CH Hammertoe Mini Instrument Kit for a defect that may deform the implant's locking mechanism during insertion, potentially requiring revision surgery.
Envisiontec is recalling 172 PCA 4000 curing units that may not properly cure dental resins to specification (SKU ACC-06-1000).