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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.
Medline Industries is recalling sterile procedural trays (ENDOSCOPY-LF and SEPTO/ENDO) because sterile blades may puncture the outer foil layer of the sterile packaging. The recall affects units distributed nationwide and internationally.
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer packaging foil, potentially compromising sterility. No injuries have been reported.
Medline Industries recalls sterile pelviscopy trays because blades inside may puncture the protective foil packaging, potentially compromising sterility. 316 units distributed worldwide are affected.
Medline recalls sterile surgical trays because internal blades can puncture the outer protective foil packaging, potentially compromising sterility.
Zimmer, Inc. is recalling 84 units of the Identity Shoulder System Resection Planer due to defects discovered during training testing. Some units are unusable, potentially affecting surgical performance in shoulder procedures.
Roche Molecular Systems is recalling its cobas Influenza A/B & SARS-CoV-2 test because it has reported false negative results for Influenza A, which may delay diagnosis and treatment.
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer foil packaging, potentially compromising sterility. The recall affects 858 units distributed worldwide.
Medline Industries is recalling sterile procedural trays because sterile blades inside could puncture the outer foil packaging, compromising sterility. The recall affects units distributed worldwide.
Medline's Femoral Artery Sterile Procedural Trays are being recalled because sterile blades within the kits can puncture the outer foil layer of the sterile packaging. This puncture creates a contamination risk.
Medline Industries recalls sterile procedural trays (Wound Closure Tray and Wound Pack) distributed worldwide because sterile blades may puncture the outer foil packaging.
MEDLINE INDUSTRIES is recalling sterile surgical trays used in robotic and laparoscopic procedures because blades within the kits can puncture the outer foil packaging. The recall affects 1,212 cases (2,101 units) distributed worldwide.
Medline Industries is recalling Sterile Procedural Trays (LS MS PACK) because the sterile blade inside can potentially puncture the outer packaging layer, compromising sterility.
Bard Peripheral Vascular Inc is recalling approximately 10,815 Covera Vascular Covered Stent devices due to poor slide block bonding that may prevent proper deployment during vascular procedures.
Medline is recalling sterile procedural trays (Lot 22IBG550) because sterile blades can puncture the foil packaging, compromising sterility. Units were distributed worldwide.
Medline is recalling sterile procedural trays labeled GENERAL ENDOSCOPY because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.
Roche Molecular Systems recalls cobas SARS-CoV-2 & Influenza A/B assay kits used in clinical laboratories. The kits may produce false negative Influenza A results, potentially delaying accurate diagnosis.
Medline Industries recalls sterile surgical procedural trays because sterile blades within the kits may puncture the outer foil packaging, potentially compromising sterility. No injuries or illnesses have been reported.
Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the outer foil sterile packaging, potentially compromising sterility.
Medline recalls sterile procedural trays because sterile blades may puncture the outer foil packaging, compromising device sterility. The 314-case recall affects hospitals in the US, Canada, Japan, Mexico, Panama, Turks & Caicos, and UAE.
Medline Industries recalls sterile surgical procedural trays because blades inside could puncture the outer sterile packaging, potentially compromising kit sterility.
Trackx Technology is recalling 464 units of its Insight Base Modular Instrument Tracker because the device breaks and falls off from surgical instruments during procedures. No injuries have been reported.
Medline recalls sterile procedural trays because blades may puncture the foil packaging, potentially compromising sterility. The recall affects over 227,000 units distributed worldwide.
The collar release pin on affected Smart Correction Dual Joint Express Struts may back out, preventing proper length adjustment and potentially delaying surgical correction.
Medline sterile procedural trays for minor and breast biopsies are being recalled because sterile blades may puncture the outer foil packaging, compromising sterility. The recall affects 237 cases (1,242 units) distributed worldwide.
Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer foil sterile packaging, compromising sterility. No injuries have been reported.
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