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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.
CP Medical Inc is recalling 2,124 coated PGA sutures because they failed to meet USP minimum average value for knot pull strength.
Maquet is recalling 11 ROTAFLOW Drive units because a loose cable connection may cause fluctuating flow values on the console.
Ethicon Endo-Surgery Inc is recalling Ligamax 5 mm Endoscopic Multiple Clip Appliers due to potential holes in the Tyvek lidding that could breach sterility.
Getinge is recalling 3,633 units of Quadrox-iD Pediatric Diffusion Membrane Oxygenators because the sterile barrier system may be compromised.
Conformis, Inc. is recalling the iTotal CR Knee Replacement System because the polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Boston Scientific is recalling 139 Habib EUS RFA electrode tips because capacitive coupling may cause thermal injury to tissue outside the target area.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the German OPS Manual incorrectly states the minimum dry time for the 36 kHz Sterilization Tray.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required 30-minute drying time.
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.
Integra LifeSciences is recalling the C7000 CUSA Clarity 36 kHz Sterilization Tray because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the operator manual lists an incorrect minimum drying time for the 36 kHz Sterilization Tray.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the sterilization tray does not meet the required drying time criteria.
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.
Integra LifeSciences is recalling C7000 CUSA Clarity systems because the operator manual lists a 30-minute drying time, but 40 minutes are required for complete drying.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the operator manual underestimates the required drying time for sterilization trays.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.
The Binding Site Group is recalling 10 Optilite C-Reactive Protein Kits because the reagent has deteriorated. The kits were distributed in California and Georgia.
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Roche Diagnostics is recalling 712 units of the Elecsys Anti-HAV IgM assay because a software error caused incorrect test settings to be downloaded.
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