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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.
Cook Inc. is recalling 1,899 Pressure Monitoring Trays because excess coating material on the needle component could cause occlusion.
Cook Inc. is recalling 6,792 Pressure Monitoring Sets because excess coating material on the needle component could cause occlusion.
The FDA is recalling 12,610 units of the Multifire VersaTrack Auto Suture Hernia Stapler because a manufacturing error may cause staples to fail to advance properly.
Beckman Coulter is recalling Access Thyroglobulin Antibody II assays because biotin can cause significant result bias.
Agfa N.V. is recalling 13 DR 800 digital radiography systems because a software error may cause incorrect dose calculations during specific fluoroscopic exams.
Baxter Healthcare is recalling Gambro Cartridge Blood Sets due to a potential tubing disconnection hazard during hemodialysis treatment.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
Philips is recalling 91 ProxiDiagnost N90 units because defective thermo switches may fail to power down the system, causing the transformer to overheat and generate smoke.
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out post-operatively.
Hill-Rom is recalling 4,381 Centrella Smart+ Beds because the Bed Exit System may fail to send remote alerts to the nurse call system under specific conditions.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.
Inpeco S.A. is recalling 71 FlexLab Augomation Systems because a firmware error may dilute primary sample tubes with distilled water, potentially causing discrepant patient results.
Osteomed, LLC is recalling 153 units of Osteovationex 3cc ImpactFormula bone void filler because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.
Osteomed, LLC is recalling 651 units of Osteovation RMX 10 CC Injectable bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.
Beckman Coulter is recalling Access Thyroglobulin immunoassay kits because biotin supplements can cause significant test result bias.
Bard Peripheral Vascular Inc is recalling 400 Equistream XK Long-Term Hemodialysis Catheters because the kits contain an incorrect peel-apart introducer sheath.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
Beckman Coulter is recalling Access Free T3 Triiodothyronine assays because high levels of biotin can cause significant result bias.
Olympus is recalling 18 ShockPulse-SE Lithotripsy System transducers because a component was made with non-conforming material that could allow water ingress during sterilization.
Inpeco is recalling 97 Accelerator a3600 Automation Systems because a firmware error may dilute primary samples with distilled water during clot detection.
American Contract Systems is recalling 2,868 sterile surgical packs because they were manufactured in a facility not registered with the FDA.
American Contract Systems is recalling sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
Beckman Coulter is recalling Access Total T3 Triiodothyronine assays because high levels of biotin can cause significant result bias.
Philips is recalling Chest Pneumograph accessories because the labeling does not state that the product contains natural rubber latex.
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