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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.
Dako North America Inc. is recalling 136 PT Link Waterbath units due to a potential electrical shock hazard if the heater pad becomes wet.
Terumo CVS is recalling 274 Sarns Modular Perfusion System 8000 units due to reported malfunctions in arterial and cardioplegia monitors, including power issues and inaccurate pressure alarms.
Terumo is recalling 15 HX2 Temperature Management Systems because AC Control boards were manufactured with incorrect flux, which may cause premature failure.
Zimmer is voluntarily removing 204 ATS 3000 Automatic Tourniquet Systems worldwide after complaints of failures caused by counterfeit chips.
Stryker Howmedica Osteonics is recalling 301 units of Peri-Acetabular Prosthesis V40 Femoral Extension Components due to insufficient taper torsional strength when used with forged CoCr stems.
Trivascular is recalling 41 units of Fill Polymer Kits in European distributor inventory due to potential stopcock cracks that may cause leaks.
MOOG Medical Devices Group is voluntarily recalling specific EnteraLite Infinity enteral feeding pumps because a PCB defect may cause the device to shut down.
Terumo CVS is recalling Sarns Modular Perfusion System 8000 units due to reported malfunctions in arterial and cardioplegia monitors, including power issues and inaccurate pressure alarms.
Terumo is recalling 19 HX2 Temperature Management Systems because AC Control boards were manufactured with incorrect flux, which may cause premature failure.
Terumo CVS is recalling 312 Sarns Modular Perfusion System 8000 units due to reported malfunctions in arterial and cardioplegia monitors, including power issues and inaccurate pressure alarms.
Progressive Medical Inc. is recalling 70 boxes of PMI Endoscopic Dissectors because some sterile packages had broken seals, potentially compromising sterility.
Synthes USA HQ, Inc. is recalling 8 units of External Fixation System Tube to Tube Clamps because the provided insert incorrectly states the product is MR safe, while the device is actually MR Conditional.
Gulf South Medical Supply is recalling Select Medical Products Vinyl Powder-Free Exam Gloves because they were shipped before U.S. Customs cleared them for sale.
Horiba Medical is recalling ABX PENTRA Creatinine 120 CP reagent because a calibration alarm prevents the assay from being used.
Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that may cause unintended pump stoppage during surgery.
Primus Medical LLC is recalling 342 Prime Bed TL500 hospital beds because retaining washers and clevis pins may fail, causing the bed frame to collapse.
Stryker Howmedica Osteonics Corp. is recalling 165 Hoffman LRF Telescopic Struts because three complaints reported the devices breaking during load-bearing use in patients weighing over 250 lbs.
Merit Medical Systems is recalling Cytosol Ophthalmics Balanced Salt Solution kits due to a lack of assurance of sterility and potential endotoxin contamination.
Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that may cause unintended pump stoppage during surgery.
Sorin Group USA is recalling S5 Perfusion Systems due to motor controller faults that may cause unintended pump stoppage during surgery.
Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that could cause unintended pump stoppage during surgery.
Sorin Group USA recalled two Sorin C5 Perfusion Systems due to a motor controller fault that could cause pump stoppage during surgery.
Sendx Medical Inc. is recalling 767 ABL80 FLEX CO-OX analyzers because a software issue may cause incorrect reporting of hemoglobin fractional parameters.
Kerr Corporation is recalling AlgiNot dental impression material because it may cure harder than expected, potentially causing tooth fractures in patients with loose teeth.
Kimberly-Clark is recalling specific lots of MicroCool sterile surgical gowns because package seams may not be properly sealed, potentially compromising sterility.
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