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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
ACE Surgical Supply oral surgery tray kits are recalled because the outer packaging may be incompletely sealed, potentially compromising sterility. The kits were distributed throughout the United States and Canada.
Surgical procedure kits supplied by Henry Schein may have incompletely sealed outer bags, potentially compromising sterility. Affected units should not be used.
Stradis Healthcare is recalling Medical Vein procedure kits due to potentially incomplete sealing of the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.
Stradis Medical recalls Henry Schein surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. No injuries reported.
Stradis Healthcare is recalling Ablation Pack Item No. 682-130 due to incomplete outer bag seals that may compromise sterility. The defect may allow contamination of surgical kits.
Stradis Healthcare is recalling surgical procedure kits for perioral surgery due to a manufacturing defect that may result in incomplete outer bag sealing. This could compromise the sterility of the kits.
Stradis Medical recalls Henry Schein Basin Pack surgical trays due to potentially incomplete outer packaging seals that may compromise sterility of the medical kits.
Stradis Medical is recalling HENRY SCHEIN ENT surgical kits distributed nationwide due to defective outer bag sealing that may compromise sterility. Affected kits were distributed across the US and Canada.
Stradis Healthcare is recalling Henry Schein labiaplasty procedure kits due to incomplete outer bag seals that could compromise sterility. The 42-unit recall affects products distributed nationwide in the US and Canada.
Cordis angiographic catheter extensions may experience separation at the male connector during use. Approximately 2,915 US units were distributed; users should verify affected lot numbers.
Siemens linear accelerator systems may allow users to select the wrong treatment site, potentially delivering radiation to the wrong location. The FDA classified this Class II recall affecting 8 units across seven U.S. states.
DeRoyal procedure kits for spinal fusion are being recalled because they contain 3M Health Care Steri Drapes that have been recalled by 3M. The affected 16 kits were distributed to healthcare facilities in 23 US states.
Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.
Siemens IMMULITE 2000 allergen testing kits may produce falsely elevated results for mold allergen-specific IgE, potentially leading to incorrect mold allergy diagnoses.
DeRoyal is recalling 144 shoulder arthroscopy procedure packs that contain recalled 3M Health Care Steri Drapes. The packs were distributed across 23 U.S. states.
Stradis Healthcare is recalling Endovenous Packs due to incompletely sealed outer bags that may compromise kit sterility. No illnesses have been reported.
DeRoyal Industries voluntarily recalled 3 kits of its OPEN SHOULDER PROCEDURE PACK RF (Lot 56391733, expiring 3/1/2024) starting November 2022. The recall affects multiple U.S. states.
Stradis Healthcare is recalling surgical procedure trays and kits due to manufacturing defects that may result in incomplete sealing of the outer bag, potentially compromising sterility. Affected products were distributed nationwide in the US and Canada.
Stradis Healthcare is recalling surgical and dental procedure kits due to manufacturing defects that may result in incomplete outer bag sealing and compromised sterility.
Stradis Medical recalled 20 oral surgery implant packs with incomplete outer bag sealing that may compromise sterility. Affected lot numbers are 22228490663 and 22242491516, distributed in the US and Canada. No illnesses reported.
DeRoyal Industries is recalling 16 units of the DeRoyal CRANI PACK (Lot 56705261, expiring 6/1/2025) distributed across multiple U.S. states. The specific reason for this Class II recall is not disclosed in the source notice.
Stradis Medical is recalling medical and surgical procedure trays with incomplete outer bag sealing, which may compromise sterility. The recall affects 150 units distributed nationwide in the US and Canada.
Zimmer Biomet is voluntarily recalling 284 NexGen tibial knee components due to higher revision rates when paired with specific femoral components. Patients with these implant combinations should contact their surgeon.
DeRoyal is recalling 146 surgical procedure kits containing recalled 3M Steri Drapes. The kits were distributed to medical facilities in 23 US states.
DeRoyal Industries recalled 48 kits of the TOTAL KNEE PACK surgical product in November 2022. The specific reason for the recall was not disclosed in the public notice.
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