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
Integra LifeSciences is recalling a Cranial Access Kit due to packaging defects that may compromise sterility. The product was distributed worldwide.
Integra LifeSciences is recalling 8,906 units of the Cranial Access Kit because the sterile packaging failed integrity testing, potentially compromising sterility. Units were distributed worldwide.
Olympus Corporation is recalling 18 colonoscopes with missing adhesive that protects against physical stress. The missing protective adhesive could allow device failure under vibration, temperature fluctuation, or shock.
LINK BiMobile hip implant liners are being recalled because packaging incorrectly identifies the insert type as F instead of G. This labeling error could delay surgery or result in the wrong component being used.
Olympus is recalling certain repaired Model CF-HQ190I colonoscopes assembled without protective adhesive, which may cause equipment failure under vibration, temperature changes, or shock.
Acumed LLC is recalling 2,952,121 units of Acu-Loc bone plates, screws, and accessories distributed worldwide because they were placed on the market without FDA pre-market clearance. The safety and effectiveness of these devices have not been verified by the FDA.
Olympus Corporation of the Americas is recalling Colonoscope Model PCF-Q180AL units that were assembled without protective adhesive. This missing adhesive protects the device from vibration, temperature fluctuations, and physical shock during use.
Zyno Medical recalls Z800 infusion pumps (Model Z-800WF) with software version 5.2.05 due to a potential alarm volume malfunction. The alarm may revert to low volume, delaying therapy and risking organ failure in extreme cases.
Medline Industries recalls multiple medical device kits and trays manufactured with components that may lack sterility. The affected solutions could be non-sterile, posing a potential safety risk.
United Orthopedic Corporation is recalling the USTAR II Hip System Press-Fit Curved Stem due to a potential risk that the implant curved stem may be oriented incorrectly. The FDA Class II recall affects 598 units.
Abbott Molecular recalls five Vysis in-vitro diagnostic kits that were intended for export and shipped to U.S. customers without approval or registration per U.S. specifications.
Parker Laboratories is recalling Tensive Conductive Adhesive Gel due to five complaints regarding incorrect viscosity. The affected product was distributed across multiple US states and internationally.
Abbott Molecular recalled M1000 Wash Station units shipped to U.S. customers without FDA approval or registration. The devices were intended for export only and not approved for U.S. distribution.
Abbott Molecular shipped two in-vitro diagnostic FISH probe kits to U.S. customers that were intended for export only and not approved or registered per U.S. specifications. The recall affects 16 kits distributed across eight states.
GRAPHENANO Dental G-CAM denture manufacturing material is being recalled due to machining errors that render the product unusable. The recall affects 354 units distributed in Utah.
EMD Millipore has recalled Schiff Reagent Hotchkiss-McManus (lots 3094 and 3096) because units appear pink instead of colorless. Laboratories should discontinue use of affected units distributed to US states and Canada.
Windstone Medical Packaging is recalling 80 Aligned Medical Solutions ocular pack surgical kits because sterility of the included saline cannot be guaranteed.
Cardinal Health is recalling Dover brand Foley catheter kits due to components recalled by supplier Nurse Assist. Approximately 435,060 units were distributed to the US, Europe, Japan, and Latin America.
Baxter is recalling Exactamix Pro 2400 pharmacy mixing devices due to a software error in versions 2.0.8 and 2.1.8 that may cause over-delivery of ingredients.
Cardinal Health Dover Foley catheters (7,800 units distributed in the US, EMEA, Japan, and Latin America) are being recalled because convenience kits were manufactured with components previously recalled by Nurse Assist.
Cardinal Health is recalling multiple Argyle Suction Catheter Tray models due to defective components. The kits containing these recalled components were distributed in the US, Europe, Japan, and Latin America.
Cardinal Health is recalling Dover-branded Foley catheter convenience kits with components that were subsequently recalled by Nurse Assist. The recall affects 195,600 units distributed in the US, EMEA region, Japan, and Latin America.
Windstone Medical Packaging is recalling a surgical kit due to inability to guarantee sterility of the included saline. The recall affects 1,528 units distributed in Florida, Illinois, and California.
Windstone Medical Packaging recalled 128 surgical eye kits because the included saline cannot be guaranteed sterile, risking post-operative infection.
Cardinal Health is recalling 4,620 Dover Foley catheter convenience kits due to components that were recalled by Nurse Assist. The kits, distributed in the US, EMEA, Japan, and Latin America, contain silicone and latex catheters.