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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 recalls non-sterile procedural trays (LAPAROTOMY CDS) because sterile blades within the kits may puncture the outer foil packaging, compromising sterility.
Certain Siemens fluoroscopic X-ray systems may only boot into backup mode after an abrupt shutdown, preventing full operation. This could necessitate cancelling or switching to alternative treatment systems.
Medline Industries is recalling 420 units of UNITE FOOT & ANKLE Screws nationwide due to observed intra-operative screw failure when used with specific drill bit sizes. The failure occurs due to excessive torque during surgical insertion.
Medline Industries recalls non-sterile Total Knee procedural trays because sterile blades inside can puncture the outer foil packaging. This could compromise sterile blade integrity.
Medtronic Perfusion Systems is recalling 1,340 units of the Affinity Fusion Oxygenator due to reports that the Temperature Monitoring Adapter can come loose during or after use in cardiopulmonary bypass procedures.
Medline Industries is recalling 45 units of procedural trays containing sterile surgical blades. The sharp blades may puncture the outer sterile packaging, potentially compromising sterility and increasing infection risk.
Medline Industries recalls non-sterile orthopedic procedural trays that may contain sterile blades capable of puncturing the protective foil packaging, compromising sterile barriers.
Medtronic is recalling Affinity Fusion Oxygenators because the Temperature Monitoring Adapter may come loose during setup or disassembly of the heart-lung machine used in cardiac surgery. No injuries have been reported.
Biomet is recalling certain OSS Modular Arthrodesis Nails due to missing locking bolts that could require extended surgery. Affected units are Lot 136620.
The temperature monitoring adapter on Medtronic's Affinity Fusion Oxygenator may come loose during cardiopulmonary bypass procedures. The manufacturer has received multiple complaints about this issue.
Bard Peripheral Vascular is recalling multiple catheter repair kits because the adhesive may be hardened or coagulated, rendering the kits unusable. Approximately 7,520 units were distributed worldwide.
MEDLINE INDUSTRIES is recalling 420 units of UNITE Foot and Ankle surgical screws (Lot 810304) due to observed intra-operative failure when pre-drilled and implanted with excessive torque.
Medtronic is recalling 2,937 Affinity Fusion Oxygenators used in cardiac surgery because the Temperature Monitoring Adapter may detach during setup or disassembly.
CooperSurgical is recalling a lot of Biopsy Medium used in IVF procedures because the product may contain an incorrect medium that could degrade embryos. No illnesses have been reported.
Medtronic is recalling AxiEM Non-Invasive Patient Trackers due to increasing complaints that users cannot verify their navigation instruments work properly during image-guided surgery. The verification failure affects approximately 1,867 devices worldwide.
Turbett Surgical Container TS1200 units may have weld failures that could breach the sterile barrier, potentially allowing unsterile instruments to be used in medical procedures and risking infection.
Medtronic has recalled Custom Pack Perfusion Tubing Packs used in cardiopulmonary bypass procedures. The Temperature Monitoring Adapter on the oxygenator may detach during setup or disassembly.
Biomet is recalling 157 units of Vanguard Knee System prosthesis components incorrectly labeled as different sizes or surgical sides. Surgeons relying on labels could implant the wrong size or side, requiring corrective surgery.
Medline Industries is recalling non-sterile procedural trays containing sterile blades that may damage sterile packaging due to blade puncture risk. Lot 22IBQ980. No illnesses reported.
W L Gore & Associates is recalling 14 units of the GORE CARDIOFORM Septal Occluder (GSX0030A) due to incomplete quality test documentation. The missing verification of device release could pose a potential risk of device failure and serious complications.
SynCardia Systems is recalling its Total Artificial Heart System due to reported tears in the cannula caused by wear and tear stress. Approximately 1,732 systems worldwide are affected.
Turbett Surgical Container TS1000 may have weld failures that breach the sterile barrier, potentially resulting in unsterile instruments being used in medical procedures and risking patient infection or injury.
Medline Industries recalls 190 UNITE foot and ankle drill bits due to observed screw failure during surgery. When used to pre-drill holes for certain screw sizes, the drill bits may fail under surgical torque, creating risk during procedures.
Medline Industries is recalling non-sterile laparoscopic procedural trays containing sterile blades that may puncture the outer packaging, potentially breaching the sterile barrier. 260 cases have been distributed nationwide.
MEDLINE is recalling procedural trays because sterile blades within the kits could puncture the outer foil packaging, potentially breaching the sterile barrier.
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