Category
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.
Zimmer Biomet is recalling 90 units of the XP-XP Tibial Tray because the locking bar may not fully engage.
Zimmer Biomet is recalling 78 units of XP-CR Tibial Trays because the locking bar may not fully engage.
Zimmer Biomet is recalling 384 units of the XP-XP Tibial Tray - Interlok 83 mm because the locking bar may not fully engage.
Stryker is recalling 946 Berchtold Chromophare F528 surgical lights because the back cover of the light head was insufficiently assembled and could fall off.
Stryker is recalling 3,344 Berchtold Chromophare F628 surgical lights because the back cover of the light head was insufficiently assembled and could fall off.
Zimmer Biomet is recalling 82 units of the XP-CR Tibial Tray because the locking bar may not fully engage.
Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments due to a possibility of insufficient sterilization.
Instrumentation Laboratory is recalling 364 ROTEM ex-tem kits because they may produce prolonged clotting times. The recall affects specific lots distributed in the US and internationally.
Zimmer Biomet is recalling 454 units of XP-CR Tibial Trays because the locking bar may not fully engage.
Zimmer Biomet is recalling 50 units of the XP-XP Tibial Tray - Interlok 59 mm because the locking bar may not fully engage.
Zimmer Biomet is recalling Vanguard XP Tibial Trays because the locking bar may not fully engage. The recall covers units distributed in the US and internationally.
Zimmer Biomet is recalling 973 units of the XP-XP Tibial Tray because the locking bar may not fully engage.
Zimmer Biomet is recalling 1,282 units of the XP-XP Tibial Tray because the locking bar may not fully engage.
Zimmer Biomet is recalling 369 units of the XP-CR Tibial Tray - Interlok 75mm because the locking bar may not fully engage.
Zimmer Biomet is recalling 84 units of Vanguard XP Tibial Tray 73 mm because the locking bar may not fully engage.
Zimmer Biomet is recalling 45 units of XP-CR Tibial Trays because the locking bar may not fully engage.
Zimmer Biomet is recalling 1,221 units of the XP-XP Tibial Tray because the locking bar may not fully engage.
Zimmer Biomet is recalling 180 units of XP-CR Tibial Trays because the locking bar may not fully engage.
Zimmer Biomet is recalling 857 units of XP-XP Tibial Trays because the locking bar may not fully engage.
Zimmer Biomet is recalling 327 units of XP-CR Tibial Trays because the locking bar may not fully engage.
Zimmer Biomet is recalling 43 units of Vanguard XP Tibial Tray 65 mm because the locking bar may not fully engage.
Instrumentation Laboratory Co. is recalling 44 ROTEM ex-tem kits (Lot 42255801) because they may produce prolonged clotting times.
Zimmer Biomet is recalling 123 units of Vanguard XP Tibial Trays because the locking bar may not fully engage.
Zimmer Biomet is recalling 375 units of the XP-CR Tibial Tray - Interlok 65mm because the locking bar may not fully engage.
Zimmer Biomet is recalling 1,210 units of the XP-XP Tibial Tray because the locking bar may not fully engage.
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