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.
Boston Scientific is recalling 41,191 VISIONIST CRT-P EL MRI devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 28,911 VALITUDE CRT-P EL MRI devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 63,851 PROPONENT DR EL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Abbott is recalling 85,803 TactiFlex Sensor Enabled Ablation Catheters in the D-F curve after becoming aware of tip detachment events during removal from the packaging.
Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1T180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Boston Scientific is recalling 223,163 ESSENTIO DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Boston Scientific is recalling 7,488 ACCOLADE DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1TQ180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
Abbott is recalling 11,810 TactiFlex Sensor Enabled Ablation Catheters in the F-J curve after becoming aware of tip detachment events during removal from the packaging.
American Contract Systems is recalling 32,433 adult central line insertion supply kits that were re-gassed after a nonconformance, without validation for multiple sterilization cycles.
Kico Knee Innovation Company is recalling 21 ARVIS Shoulder systems after a complaint identified an issue with the AI surgical planning software that may cause implant malalignment.
Baxter is recalling 16,416 CLEARLINK System straight-type extension sets from one lot because the IV sets may leak.
Baxter is recalling 1,440 CLEARLINK System non-vented solution sets from one lot because the IV sets may leak.
Baxter is recalling 8,368 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a 0.2 micron filter from one lot because the IV sets may leak.
American Contract Systems is recalling cysto convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Spacelabs Healthcare is recalling 16,898 DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.
BioPro is recalling 147 femoral head implants over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.
American Contract Systems is recalling spine, laminectomy and neuro angio convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
American Contract Systems is recalling angiography and coronary convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Baxter is recalling 136,512 CLEARLINK System DUO-VENT solution sets across three lots because the IV sets may leak.
Baxter is recalling 49,200 Continu-Flo solution sets with a 4-way stopcock extension set because the IV sets may leak.
Boston Scientific is recalling 490 LGX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.
Ferno-Washington is recalling 138 Ferno Power X2 powered ambulance cots because the fastening post hardware could loosen, allowing the post to detach from the cot.
American Contract Systems is recalling general, chest, laparotomy and interventional radiology convenience packs that were re-gassed after a sterilization nonconformance.
American Contract Systems is recalling shoulder, hip and extremity convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
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