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 319 units of XP-CR Tibial Trays because the locking bar may not fully engage.
Exactech, Inc. is recalling 22 Threaded Offset Cup Impactors because the threaded mechanism may be gritty and difficult to turn, potentially due to entrapped blast media.
Philips is recalling 5-Lead ECG sets because the connector thickness may prevent or impede I 2-Lead ECG measurements.
Smith & Nephew is recalling 12 units of Legion Hemi Step Tibial Wedges because they were inadvertently packaged with an incorrect screw component.
Philips North America, LLC is recalling two HeartStart MRx Monitor/Defibrillators because they may not have received applicable corrections from prior field actions.
Randox Laboratories is recalling calibration sera due to realigned targets for AST and ALT. The recall affects 307 kits distributed nationwide and in several foreign locations.
Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to include specific information on tether removal during implant.
Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to clarify tether removal during implant.
OMNIlife science Inc. is recalling six ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.
Stryker Communications is recalling 52 Berchtold Chromophare Dual Monitor Carrier Arms or Dual Flat Panels because the mounts may have insufficient welds.
B. Braun Medical is recalling 960 epidural trays because filter membrane damage prevents the filter from achieving its intended capacity.
OMNIlife science Inc. is recalling 14 ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.
B. Braun Medical is recalling 1,230 units of CE18TKSTN Cont. Epidural Needles because the filter membrane is damaged, preventing the device from achieving its intended filter capacity.
Cincinnati Sub-Zero Products LLC is recalling Norm-O-Temp model 111W units because the manual lacks instructions warning that exceeding 40 Celsius for extended periods can cause tissue damage.
OMNIlife science Inc. is recalling 22 ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.
Haag-Streit USA Inc is recalling specific operating microscope floor stands due to a software error in the central control unit.
B. Braun Medical is recalling 100 units of Espocan Spinal/Epidural Trial Needles because damage to the filter membrane prevents the filter from achieving its intended capacity.
B. Braun Medical is recalling 250 units of FEF 100N Flat Epidural Filters because damage to the filter membrane prevents the device from achieving its intended filter capacity.
Siemens Medical Solutions is recalling syngo.CT software version VA48A_SP5.5 for specific SOMATOM CT models due to scanning workflow interruptions and unexpected user notifications.
B. Braun Medical is recalling 200 units of Accu-Bloc Perifix Kits because damaged filter membranes may prevent the device from achieving required filter capacity.
Integra LifeSciences Corp. is recalling 237 units of the Jarit GEMINI CLAMP because a small crack may cause corrosion and breakage after repeated sterilization.
Cincinnati Sub-Zero Products LLC is recalling Norm-O-Temp model 111Z devices because the manual lacks instructions warning that exceeding 40 Celsius for extended periods can cause tissue damage.
Becton Dickinson & Co. is recalling 9 units of BD Kiestra InoqulA+ Software Version 20.3 due to an anomaly that may cause specimen and plate mismatches.
Roche Diagnostics is recalling cobas e 601 modules due to a quality issue with high pressure solenoid valves that may cause inaccurate test results.
Becton Dickinson & Co. is recalling 4 units of BD Kiestra InoqulA Software Version 20.3.IVD due to an anomaly that may cause specimen and plate mismatches.
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