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 is recalling CPT Degree Taper and Femoral HD devices due to unvalidated packaging operations at a Puerto Rico facility.
Zimmer is recalling specific hip prosthesis models because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling 7,044,680 compression screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling 7,044,680 orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Zimmer is recalling NEXGEN Osteotomy Cortical Bone Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer, Inc. is recalling 7,044,680 units of Pressfit Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated.
Zimmer is recalling FEM HD ION hip implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling Versys Heritage Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Zimmer is recalling specific bone screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling 7,044,680 units of bipolar liners and multipolar cups because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling specific lots of Modular Austin Moore and Moore Hip ProS hip implants because packaging operations at a Puerto Rico facility were not properly validated.
Synthes, Inc. is recalling 3.2 mm Guide Wires because the label lists an incorrect raw material. The recall covers units distributed in the USA, Canada, and Switzerland.
Zimmer is recalling NEXGEN knee implant components because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling specific sterile orthopedic screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling Magna-Fx Cannulated Screw Fixation Systems because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling HGP II Acetabular Cup Bon due to unvalidated packaging operations at its Puerto Rico facility, despite passing seal integrity tests.
Zimmer, Inc. is recalling specific hip prosthesis models because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Implantech Associates Inc is voluntarily recalling Gelzone Shoulder Sleeves because the Velcro closure may not meet robustness requirements.
Zimmer is recalling 7,044,680 units of Herbert Bone Screws and Cannulated Bone Screws because packaging operations at a Puerto Rico facility were not properly validated.
Zimmer is recalling 7,044,680 one-piece lag screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Synthes, Inc. is recalling 12 units of Matrix Mandible Short Threaded Drill Guides because they have a gray band instead of the green band shown in the guide.
Stryker Howmedica Osteonics Corp. is recalling 211 units of the Navigation Compatible Accolade Broach Handle because the impaction plate may dissociate or fracture from the main body.
Tandem Diabetes Care is recalling specific lots of T:slim insulin cartridges due to a risk of leaking, which could cause incorrect insulin delivery.
Boston Scientific is recalling specific lots of Coyote balloon dilation catheters because the balloons may not deflate as expected during procedures.
Boston Scientific is recalling Coyote PTA Balloon Dilatation Catheters because the balloons may not deflate as expected during procedures.
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