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.
GE Healthcare is recalling 1,221 ViewPoint 6 systems because the Patient History tab in software versions 6.15.3 and 6.15.4 may not include complete patient medical history information.
DSAART is recalling 369 AART Silicone Carving Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
Zimmer Surgical is recalling 498 Zimmer Dermatome AN units because the devices may have a misaligned thickness control bar.
DSAART is recalling 35 AART Calf Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
Smith & Nephew is recalling 168 BIOSURE HA Screws, 6mm x 20mm, due to a labeling error on the affected lot.
DSAART is recalling 118 AART Gluteal Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
DSAART is recalling 41 AART Pectoral Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
SeaSpine Orthopedics is recalling 310 NorthStar OCT Navigation items because the surgical technique guide incorrectly identified Medtronic Infinity toolcards as compatible.
Copan Italia is recalling 122,850 units of 1ml DTT liquid reagent because treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
Copan Italia is recalling 122,850 units of 1ml DTT reagent supplied with a sputum transfer device because treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
Zimmer Surgical is recalling 839 Zimmer Air Dermatomes because the devices may have a misaligned thickness control bar.
Datascope is recalling 47 Cardiosave Rescue units to issue an instructions for use addendum updating the Vibration and Shock Table to reference the correct standards.
Datascope is recalling 11,470 Cardiosave Hybrid units to issue an instructions for use addendum updating the Vibration and Shock Table to reference the correct standards.
Draeger is recalling 2,050 ErgoStar CM 60 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.
Draeger is recalling 118,850 ErgoStar CM 55 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.
Draeger is recalling 191,470 ErgoStar CM 45 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.
Draeger is recalling 14,420 ErgoStar CM 40 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.
Medline is recalling 18,000 units of Curad Quick Strip Fabric Bandages because packaging may exhibit open seals that could compromise the sterility of the product.
Bard Peripheral Vascular is recalling 1,240 Safe-T-Centesis 6 Fr Catheter Drainage Trays because the safety indicator can show the catheter in the sharp position when it is blunt.
Medline is recalling 4,381,400 Quick Strip Plastic Sterile Adhesive Bandages because packaging may exhibit open seals that could compromise the sterility of the product.
Medline is recalling 1,566,500 Fur Friends Plastic Sterile Adhesive Bandages because packaging may exhibit open seals that could compromise the sterility of the product.
Medline is recalling 6,989,900 Quick Strip Fabric Sterile Adhesive Bandages because packaging may exhibit open seals that could compromise the sterility of the product.
Medline is recalling 1,725,600 Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", because packaging may exhibit open seals that could compromise the sterility of the product.
Philips is recalling 110 Azurion R3.0 systems shipped with a FlexArm stand but without the Source-to-Skin Distance spacer needed to meet the FDA minimum 38 cm requirement.
Medline is recalling 15 Medline Perfusion Syringes because they contain BD Luer Tip Caps from trays that failed routine biocompatibility testing.
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