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 recalls 251 HYDRATOME RX 44-30MM/450CM units worldwide due to sterile barrier breach that compromises device sterility.
Bard Peripheral Vascular Inc is recalling 20,400 Safe-T PLUS pediatric lumbar puncture trays due to manometer leaking and mating failures. The devices were distributed nationwide and internationally to healthcare facilities.
Boston Scientific is recalling 98 units of the JAGTOME RX 39-30-260-025 medical device due to compromised sterile barrier that affects device sterility. Units were distributed worldwide.
Boston Scientific is recalling 96 units of JAGTOME RX medical devices due to a sterile barrier breach that compromises device sterility. Patients should contact their physician if they received this device.
Boston Scientific is recalling 142 units of DREAMTOME 44-30MM/450CM medical devices distributed worldwide due to a sterile barrier breach that compromises device sterility. Affected lot numbers are 27625066 and 27805561.
Boston Scientific is recalling 98 JAGTOME RX medical devices due to a sterile barrier breach. The affected units were distributed worldwide.
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.
Bard Peripheral Vascular Inc is recalling 8,630 lumbar puncture trays due to manometer failure causing leaking and mating issues. Devices were distributed nationwide in the U.S. plus Puerto Rico, Costa Rica, and Hong Kong.
CellEra LLC is recalling Vitale Silver calcium alginate wound dressings nationwide due to incorrect instructions for use containing language beyond FDA-cleared content.
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.
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.
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.
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 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.
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.
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.
CoolSeal Generator units (REF: CSL-200-50) may have a manufacturing defect preventing them from meeting electrical safety standards, potentially resulting in unintended energy delivery to patients.
Stryker is recalling the 1688 Camera Control Unit due to a software defect that causes the surgical monitor image to flip upside-down. This could lead to surgeon error or the need for additional surgical intervention.
Envisiontec is recalling 172 PCA 4000 curing units that may not properly cure dental resins to specification (SKU ACC-06-1000).
RayStation/RayPlan versions 6.0.0.24 through 9.2.0.483 incorrectly display selected images as both primary and secondary when animation playback is running, affecting treatment planning visualization.