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.
DePuy Mitek is recalling 401 Mitek Screw and Washer Depth Gauges because a design offset causes readings to be approximately 3.2mm shorter than the actual bone hole length.
Custom Healthcare Systems is recalling 40 units of CHS Custom Convenience Kit-INJECTION TRAY because incorrect sealing specifications compromised product sterility.
Howmedica Osteonics Corp. is recalling 58 units of the Tritanium TL Steerable Inserter because the locking mechanism may fail to function as intended due to lack of lubrication.
Custom Healthcare Systems is recalling 24 units of Penrose Drain Convenience Kits because incorrect sealing specifications compromised product sterility.
Siemens Healthcare Diagnostics is recalling StreamLab Refrigerated Storage Module 9000 units because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.
Custom Healthcare Systems is recalling 1,250 suture removal kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 100 units of convenience kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 630 CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.
Siemens Healthcare Diagnostics is recalling 441 APTIO 15000 Refrigerated Storage Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.
Custom Healthcare Systems is recalling vaginal speculums because incorrect sealing specifications compromised product sterility.
Siemens Healthcare Diagnostics is recalling 186 StreamLab Automation Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.
Custom Healthcare Systems is recalling 250 units of 22G LP Needle Convenience Kits because incorrect sealing specifications compromised product sterility.
Shimadzu is recalling one TRINIAS Digital Angiographic System in Louisiana due to a software issue that may cause the C-arm to move unexpectedly, posing a risk of contact with patients or staff.
Custom Healthcare Systems is recalling 80 units of Toenail Removal Kits because incorrect sealing specifications compromised product sterility.
Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, communication, and imaging functions.
ESAOTE S.P.A. is recalling 10 MyLab Alpha Model 7400 ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.
Ecolab is recalling specific lots of Disposable Accessory Kits for the Da Vinci Si Robotic system because wrinkles in the packaging seal could compromise sterility.
Custom Healthcare Systems is recalling 7,200 surgical gown kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 50 units of curved pean forceps kits because incorrect sealing specifications compromised product sterility.
GE Medical Systems is recalling 90 MRI coils because they may overheat in Mode 2, posing a risk of thermal injury to patients.
ESAOTE is recalling 10 MyLab Seven ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.
Custom Healthcare Systems is recalling 100 units of toothbrush kits because incorrect sealing specifications compromised product sterility.
Canon Medical System is recalling 252 MRI systems because the displayed SAR value may be lower than the actual value, potentially exceeding safety limits.
Custom Healthcare Systems is recalling 4,500 fenestrated drape kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling Webster Needle Holder Convenience Kits because incorrect sealing specifications compromised product sterility.
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