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, Inc. is recalling 47,682 units of 4.0 mm Cancellous Screws because they failed leak tests due to inner cavity damage.
Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Trauma Screws because they failed leak tests due to inner cavity damage.
AMO Puerto Rico Manufacturing is recalling specific Tecnis CL intraocular lenses because they may be labeled with the incorrect diopter power.
Hyperion Medical is recalling brochures and website information for the HyperBlue 1530 laser because they promoted features not cleared by the FDA.
Gambro Renal Products is recalling Prismaflex HF 1000 dialysis sets because connector breakages can cause leakage of liquid or blood.
Zimmer, Inc. is recalling 412 units of 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain assembled to the rasp during use.
Zimmer, Inc. is recalling 412 nonsterile VER2 D8L Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Carestream Health is recalling 589 Kodak DirectView DR 7500 diagnostic x-ray systems because the x-ray tube assembly may detach from the overhead crane due to insufficiently tightened hardware.
Enhancement Medical is recalling 17,875 units of EXP-150 Injectable Gel because a production change altered the final gel weight. The recall covers all lots distributed in the US and Canada.
Zimmer, Inc. is recalling 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain attached to the rasp during use.
Gambro Renal Products is recalling Prismaflex M150 dialysis sets because connector breakages can cause liquid or blood to leak.
Cardiovascular Systems, Inc. is recalling 48 Diamondback 360 Peripheral Orbital Atherectomy Systems because the saline sheath may crack or fracture, releasing particulate during use.
Medical Positioning Inc is recalling two Model # 1019 HUT tables due to a component defect that may cause the table to drop into the Trendelenburg position more rapidly than normal.
Gambro Renal Products is recalling Prismaflex M100 dialysis sets because connector breakages can cause leakage of liquid or blood.
Gambro Renal Products is recalling Prisma M100 PRE pump infusion sets because connector breakages can cause liquid or blood to leak.
Gambro Renal Products is recalling PrisMARS Kits because connector breakages can cause liquid or blood to leak.
Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Gambro Renal Products is recalling Prisma M 60 PRE sets because connector breakages can cause leakage of liquid or blood.
Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Medical Positioning Inc is recalling 20 Rapid Response HUT tables because a defective component may cause the table to drop into the Trendelenburg position too rapidly.
Zimmer, Inc. is recalling 412 units of nonsterile VI DBL OFFST W/ LRG STPL, LT rasps because the handle may fail to remain assembled during use.
Zimmer, Inc. is recalling 412 nonsterile Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Biomet, Inc. is recalling 37 units of Distal Radius Fracture Repair System drill guides because they become stuck in the jig during use.
Gambro Renal Products is recalling Prisma M 100 PRE sets because connector breakages can cause leakage of liquid or blood.
Gambro Renal Products is recalling Prismaflex M60 sets because connector breakages can cause leakage of liquid or blood.
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