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.
Minimum severity
SeaSpine Orthopedics is recalling 74 Reef TA Inserters due to potential difficulty disengaging the device during spinal fusion surgery, which may require surgical revision and alternate instrumentation.
Boston Scientific is recalling the Preventive Maintenance Kit ICEFX because certain desiccant tube subassemblies have end caps that were not correctly tightened during manufacturing. The affected batch was distributed in Canada, France, Germany, Italy, and the United States.
Quidel Corporation is recalling QuickVue Dipstick Strep A Test kits due to potential for false positive results. Affected units were distributed nationwide and internationally.
Boston Scientific is recalling Encore 26 Inflation Devices due to potential foreign material particles that could migrate into balloon catheters during use. No injuries have been reported.
Encore Medical recalls the Altivate Reverse Wedge Glenoid Reamer (Model 804-06-312) because the reamer may kick or bind during surgical use. Approximately 907 units were distributed nationwide across the United States.
Boston Scientific is recalling certain ICEfx Cryoablation System units worldwide due to desiccant tube end caps that were not correctly tightened during manufacturing.
AVID Medical is recalling Halyard ENT PACK convenience kits (Model JACK421-04) due to potential open header bag seals that could compromise product sterility. The recall affects 57 units distributed in Florida.
Omnia Medical is recalling 15 units of TiBrid Stand Alone Intervertebral Body Fusion Device screwdrivers due to failure of fusion system instruments in the field. Units were distributed nationwide.
The FDA is correcting labeling for CorNeat EverPatch surgical matrices to include prevention and management guidance for wound dehiscence. This Class II recall addresses gaps in product instructions following complaints.
Merit Medical is recalling 10Fore Hemostasis Valves due to a manufacturing defect where the silicone quad ring may be deformed or damaged, posing a risk of foreign body in the fluid pathway.
Encore Medical is recalling 447 units of the ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE because the surgical reamer may bind or kick during use.
Omnia Medical is recalling the TiBrid Stand Alone spinal fusion punch awl instruments due to failure in the field. The recall involves 15 units distributed in Arizona, California, New Jersey, Nevada, Oklahoma, and Washington.
Siemens Healthcare's Atellica CH urinary and cerebrospinal fluid protein test (11,811 units) may produce falsely depressed results in patient samples and quality control materials. Affected laboratories should verify test results and contact the manufacturer.
Boston Scientific is recalling Encore 26 Inflation Devices due to the risk that foreign material particles could migrate into balloon dilation catheters during use in interventional procedures.
Waldemar Link is recalling 8 LinkSymphoKnee knee prosthetic components manufactured with uncoated security screws instead of coated screws. Uncoated screws in the implant present a risk of corrosion and potential implant failure.
B.Braun is recalling 58 units of CELSITE BABYPORT IV port sets (Lot 37041185) due to potential vessel damage or tearing. The defective units were distributed in Pennsylvania.
Philips IntelliSpace Cardiovascular Software 8.0.0.4 displays outdated information due to a software issue. Four units are distributed nationwide across Georgia, North Carolina, and Texas.
Boston Scientific is recalling 1,369 UroMax Ultra Kit inflation devices worldwide due to potential migration of foreign material particles into balloon dilation catheters.
AVID Medical is recalling 228 Halyard CPT BASIC IR PACK convenience kits (Model 1646381) due to potential for open header bag seals that could compromise sterility. The kits were distributed in Florida.
Encore Medical is recalling 927 units of the ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD due to a potential for mechanical failure during surgical use, where the reamer may kick or bind. No injuries have been reported.
NOXBOX LTD is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems due to high failure rates of the internal pump. Affected units require pump replacement.
Boston Scientific is recalling the NephroMax Kit because foreign material particles could migrate from the inflation device into balloon dilation catheters during use. Worldwide distribution of 458 units.
Wasatch Photonics is recalling 192 Raman spectrometers due to two potential laser safety failures. The devices could experience laser diode overcurrent or fail-unsafe conditions under extreme vibration or excessive force, though no incidents have been reported.
Fortress Introducer Sheath System units may have been packaged with pouch labels showing incorrect device size information, affecting 2,500 units distributed in the US and internationally.
ReQuest Measles IgM test kits manufactured by Quest International lack FDA premarket approval or clearance. Approximately 376 kits distributed nationwide in Utah, Texas, and Arizona are subject to recall.