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.
Avid Medical is recalling TruCustom GENERAL PACK kits because some contain needles with loose polypropylene foreign material above release specifications.
Keystone Dental Inc. is recalling 72 units of the Max Implant System Bone Tap because an 8mm diameter tap was incorrectly marked and labeled as 7mm.
Terumo Medical Corporation is recalling 33 units of Destination Guiding Sheath catheter introducers because the tucking depth feature is marginally outside the upper specification.
Philips is recalling 157 ProGrade R1 digital x-ray detectors because weak WiFi connections can cause image transfer failures, requiring patients to be re-exposed to radiation.
DePuy Orthopaedics is recalling 23,053 DELTA XTEND Reverse Shoulder System implants because the epiphysis may not assemble to the stem, potentially causing surgical delays.
Siemens Medical Solutions is recalling wireless foot switches for Artis Q and Q.zen fluoroscopic systems because they may fail to release radiation due to external impacts.
DePuy Orthopaedics is recalling DELTA XTEND Reverse Shoulder System implants because the epiphysis may not assemble to the stem, potentially causing surgical delays.
Avid Medical is recalling 50 TruCustom DAVINCI PACK convenience kits because they may contain needles with loose polypropylene foreign material.
Siemens Medical Solutions is recalling 30 Syngo.via systems with software version VB20A to resolve bugs and inconsistent diagnoses.
Siemens is recalling ADVIA Centaur T3 kits because a barcode scanning issue on the ADVIA Centaur XPT system may affect specific lots.
Avid Medical is recalling 354 TruCustom Heart Cath Tray kits because they may contain loose polypropylene foreign material in the included needles.
Avid Medical is recalling 15 TruCustom Electro Physiology PK convenience kits because they may contain loose polypropylene foreign material in the needles.
Alcon is voluntarily recalling 300 units of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Atrium Medical is recalling 60 units of ProLite Mesh because the wrong mesh configuration was packaged in the pouch. The affected lots were distributed only to Spain.
Siemens Healthcare Diagnostics is recalling specific lots of BC Thrombin Reagent Kits because they may produce unexpectedly prolonged Thrombin Time results for normal samples.
Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Teleflex Medical is recalling Rusch Greenlite MAC 1 devices because some pouches may contain the incorrect product size, specifically MAC 2 instead of MAC 1.
Avid Medical is recalling 48 TruCustom Extremity Pack kits because they may contain loose polypropylene foreign material in the needles.
Avid Medical is recalling 24 shoulder arthroscopy kits because they may contain loose polypropylene foreign material in the needles.
Zevex Incorporated is recalling Moog Curlin Infusion Administration Sets because particulate matter was found on the spike.
Avid Medical is recalling 200 TruCustom DJ's Vascular/Neuro Tray kits because they may contain needles with loose polypropylene foreign material.
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to enclosed devices.
Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Accord Media, LLC is recalling 1,040 units of the Ultra Renew Plus medical device because it uses an unapproved green LED light to treat hyperpigmentation.
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