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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.
DeRoyal Industries Inc has recalled 19 anterior approach total hip replacement surgical kits distributed across 23 U.S. states. This Class II recall was initiated voluntarily by the manufacturer.
DeRoyal Industries voluntarily initiated a Class II recall of 170 GEO-MED local anesthesia packs distributed across 23 US states. The specific safety concern is not detailed in the recall notice.
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.
NuVasive is recalling the MAGEC 2 Rod spinal bracing system due to potential failure of the sterile packaging barrier, which could compromise device sterility.
Stryker's Power-PRO 2 surgical cot may lower unexpectedly due to damaged cables, risking soft tissue injuries to patients. The recall affects 465 units distributed in the US and internationally.
Stradis Healthcare angioplasty procedure trays may have incompletely sealed outer bags, risking sterility compromise. Affected units should not be used pending further instructions.
Stradis Medical is recalling the BASIC IMPLANT PACK (Item 40310SBI) due to incomplete outer bag sealing that may compromise sterility. 80 units were distributed nationwide and in Canada.
DeRoyal Industries is recalling 68 kits of the CNRV Peripheral VAS Pack. The voluntary Class II recall affects healthcare facilities in 23 US states with specific lot numbers.
Zimmer is recalling NexGen Option Stemmed Tibial Components due to higher revision rates when used with certain femoral components in knee replacements.
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.
HENRY SCHEIN Amnio Trays (Item No. 570-3059) manufactured by Stradis Medical are being recalled because the outer bag may be incompletely sealed, potentially compromising the sterility of the medical kit.
DeRoyal is recalling 146 surgical procedure kits containing recalled 3M Steri Drapes. The kits were distributed to medical facilities in 23 US states.
Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit sterility.
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.
DeRoyal Industries is recalling 918 PICC line procedure packs containing 3M sterile drapes that were separately recalled. The affected kits were distributed across 23 U.S. states to healthcare facilities.
DeRoyal Industries is recalling 102 HEART PACK procedure kits (Lot 57367401, expiration 3/1/2025) distributed across 23 U.S. states because they contain recalled 3M Health Care Steri Drapes.
Stradis Medical is recalling surgical procedure trays due to manufacturing defects that may leave outer bags incompletely sealed, potentially breaching kit sterility. No illnesses have been reported.
Stradis Medical recalls Henry Schein procedure trays because the outer bag may be incompletely sealed, risking sterility breach. The trays were distributed nationwide and in Canada.
Stradis Medical is recalling a dental surgical pack because the outer bag may be incompletely sealed, potentially compromising sterility. Affected units should not be used.
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.
Zimmer is voluntarily recalling NexGen Option Stemmed Tibial Component Size 7 (1,049 units) due to higher-than-expected revision rates when used with specific femoral components, based on UK registry data.
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 Healthcare is recalling surgical kits because the outer bag may be incompletely sealed, potentially compromising the sterility of the product.
Zimmer Inc. is recalling NexGen Option Stemmed Tibial Components due to clinically and statistically significant higher revision rates when used with specific femoral components. The components are being removed from inventory.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. Healthcare providers and patients should contact the manufacturer for guidance.
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