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
CAREFUSION is recalling BD MaxGuard 15 Drop Administration Sets with incorrect expiration year labels (showing 2027 instead of 2025). Use of expired product may compromise integrity and risk infection.
Fresenius is recalling 24 units of the AquaC UNO H reverse osmosis unit because internal ethernet cables lack ferrite cores, compromising electromagnetic compatibility in hemodialysis water purification systems.
GELITA MEDICAL GMBH recalled 3,596 boxes of ORCA FOAM hemostats after routine testing found higher than acceptable endotoxin levels. The surgical devices were distributed across the United States.
Ethicon recalls PDS II surgical sutures distributed in Japan due to potential incorrect material composition that could affect treatment outcomes. No injuries have been reported.
Maquet Medical Systems is expanding its recall of the CARDIOHELP HLS Set Advanced due to a potential breach in the sterility barrier that could compromise product sterility, affecting 6,871 US units and 18,670 worldwide.
CAREFUSION is recalling 17,250 BD MaxGuard Extension Set units with labels listing incorrect expiration year 2027 instead of 2025. Using expired products could compromise device integrity and create infection risk to patients and healthcare workers.
Covidien is recalling the Puritan Bennett 560 Ventilator due to a manufacturing error in turbine components that causes loss of gas supply and device inoperability. Six incidents have been confirmed from customers outside the United States.
Randox Serology I Positive Control may test negative for Hepatitis B surface antigen (HBsAg) on certain analyzers despite being designed as a positive control, potentially affecting laboratory quality control procedures.
BD MaxGuard Extension Set units have labels listing 2027 as the expiration year instead of 2025. Using expired medical devices may compromise product integrity and increase the risk of leaks and infection.
Maquet Medical Systems USA is recalling the BEQ-HLS 5050 (HLS Set Advanced 5.0) due to a potential breach in the sterility barrier that may compromise product sterility.
Maquet Medical Systems USA has expanded a recall for HLS Set Advanced 7.0, a preconnected medical device used for heart and lung support, due to a potential breach in the sterility barrier that could compromise product sterility.
46,900 BD MaxGuard Extension Sets are labeled with expiration year 2027 but should expire in 2025. Using expired product may compromise integrity and cause leaks, risking infection.
CAREFUSION is recalling 600 BD MaxGuard Extension Sets because labels list expiration year 2027 instead of 2025. Using expired products may cause leaks and infection risk.
BD MaxGuard Drop Administration set labels incorrectly list expiration year 2027 instead of 2025. Use of expired product risks compromised integrity, potential leaks, and patient or worker infection.
CAREFUSION's BD MaxGuard Extension Set is being recalled because product labels incorrectly list expiration year 2027 instead of 2025. Using expired product may compromise integrity, potentially causing leaks and infection risk.
BD MaxGuard Flow Controller Extension Set labels incorrectly list 2027 expiration instead of 2025. Use of expired product could compromise device integrity and create infection risk.
Associates of Cape Cod is recalling Fungitell STAT IVD Assay kits due to incorrect printed information on clamshells regarding reconstitution and pretreatment volumes. Users should verify procedures against official documentation before use.
Diversatek Healthcare is recalling M-Catch Retrieval Nets (Part Number REF 1175-01, Lot Number 001919) due to incorrect inner polybag labeling. 245 devices were distributed nationwide between September and October 2021.
Fresenius is recalling 6 units of the AquaC UNO H reverse osmosis unit used with hemodialysis systems due to missing ferrite cores in internal ethernet cables affecting electromagnetic compatibility.
Baxter Healthcare Corporation is recalling the CLEARLINK System Non-DEHP Solution Set nationwide due to increased customer reports of leaks in the in-line injection site device.
Isopure Corp recalls its ACDS (Acidified Concentrate Distribution and Storage) system used in hemodialysis facilities due to a potential electrical safety hazard that may result in electric shock or arcing.
ICU Medical is recalling approximately 5.8 million MicroClave Clear Connectors used in IV administration due to a manufacturing defect that creates a visible gap between the connector housing.
ICU Medical is recalling 5.8 million Trifuse Extension Sets due to a manufacturing defect that creates a visible gap between the connector's housing parts. The gap could lead to disconnection or fluid leakage during infusion.
Cook Incorporated is recalling 1,450 units of Roadrunner PC Hydrophilic Wire Guide devices due to failed sterility packaging testing. The devices may not meet sterility requirements for safe use in vascular procedures.
Carwild Corporation is recalling FABCO ORS Dental Rolls because the sterility of a new cotton source was not validated. The recalled 90 cases (4,500 units) with lot 22B0428 were distributed nationwide.