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.
Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.
Stryker is recalling 23 units of Asnis III Cannulated Screws because the length of the device was reported to be incorrect.
Micro Therapeutics Inc is recalling 62 Pipeline Embolization Devices because the instructions for use are missing specific contraindications regarding pre-existing stents and medication designations.
Ventana Medical Systems is recalling BenchMark and Discovery instruments because a heating element may separate, causing inconsistent staining without an error message.
3M ESPE is recalling Unitek Primary Stainless Steel Crowns because they were manufactured with the incorrect marginal contour edge.
Becton Dickinson is recalling 890 PrepStain Tecan US-I instruments because a rack setting was incorrectly entered during routine maintenance.
Siemens Healthcare Diagnostics is recalling PSA Assay kits for use in IMMULITE systems due to a confirmed positive bias of 20% to 23% in patient results.
Sarken, Inc. is recalling STAT! Multi-Drug Test Panels because they were distributed without adequate labeling and instructions for use, which could lead to misuse and incorrect test results.
Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.
Synthes USA HQ, Inc. is recalling 11 units of 2.4 mm VA-LCP distal radius plates that may be incorrectly etched with 'R' instead of 'L'.
Synthes USA HQ, Inc. is recalling Trauma Nail Systems because the outer packaging pouch may be compromised, potentially affecting the sterile internal pouch.
Waldemar Link is recalling five trial stems for a reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Siemens is recalling Dimension Vista 500 and 1500 systems due to a rare software issue that may cause samples to be dispensed into previously used wells.
SpineNet is recalling 400 anterior cervical cages because the instructions for use contained statements that should have been removed prior to marketing.
Zimmer is recalling specific lots of Distal Medial Humeral Locking Plates because the Chinese labels incorrectly identify right-sided implants as left-sided.
Synthes (USA) Products LLC is recalling 119,891 units of 2.4mm VA-LCP Two Column Volar Distal Radius Plates due to a labeling error in the US Technique guide.
Becton Dickinson is recalling 890 PrepStain AG systems because a rack setting was incorrectly entered during routine maintenance.
Siemens Medical Solutions USA is recalling 178 Axiom Artis C-arm angiographic x-ray systems because third-party installers may have used incorrect channel nuts.
Brainlab AG is recalling 6 units of the Frameless SRS QA Target Pointer because the pointer cap may become loose under moderate force.
Sarken, Inc. is recalling STAT! Multi-Drug Test Panels because they were distributed without adequate labeling and instructions for use, which could lead to misuse and incorrect test results.
Philips Healthcare is recalling 89 Easy Upgrade DR systems because a mirror icon on images could be misinterpreted as a right lead marker if the image is mirrored in a PACS system.
Celera Corporation is recalling OLA Buffer for Laboratory Use because the package insert listed the wrong concentration units.
Remel Inc is recalling specific lots of Oxoid Nitrofurantoin test discs because they may provide false susceptibility results.
Zimmer, Inc. is recalling NexGen Cruciate Retaining knee implant components because surgeons are using them in unapproved combinations.
Stryker Spine is recalling Oasys Midline Occiput Plates because customer reports indicate post-operative fracture of the pin connecting the tulip head to the plate body.
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