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.
Siemens Medical Solutions is recalling 510 foot switch accessories for Artis zee and Artis zeego x-ray systems because they may fail to release radiation.
Elekta Limited is recalling Agility with Integrity R3.2 software due to a potential for positional errors following automatic table movement.
Alto Development Corp is recalling surgical punches because packaging damage during transport may have compromised sterility.
3M is recalling 120,000 Surgical Clipper Professional 9681 units worldwide due to lithium-ion battery degradation risks, including excessive heat and potential venting.
Zimmer Biomet is recalling 337 Phoenix Antegrade Femoral Nail Connecting Bolts because the bolt may fracture during insertion of the femoral nail.
Zevex Incorporated is recalling Moog Curlin Infusion Administration Sets due to particulate matter found on the spike. The recall covers 56,244 cases distributed nationwide and internationally.
DePuy Mitek is recalling FMS Gravity Tube Sets because they may leak at the bulb and tube connection during arthroscopic procedures.
Stryker is recalling 1,162 Berchtold Chromophare surgical lights because missing parts could cause the equipment to fall.
Siemens Medical Solutions is recalling Artis Zee and Zeego devices due to a potential for liquid entry.
ConMed Corporation is recalling STAT 2 I.V. Gravity Flow Controllers and administration sets because they exhibit inaccurate or inconsistent flow rates.
Avid Medical is recalling 8 TruCustom Pacemaker Packs containing needles with loose polypropylene foreign material.
Avid Medical is recalling 44 TruCustom Minor Procedure kits because the included needles may contain loose polypropylene foreign material.
Elekta Limited is recalling 539 Integrity R1.2 units due to a potential for positional errors following automatic table movement.
Olympus is recalling specific urologic endoscopic working inserts and bridges because adhesive fragments may detach and enter patients during procedures.
NxStage Medical is recalling dialysate sacks because endotoxin levels may exceed the ANSI/AAMI quality standard of 0.5 EU/ml.
Avid Medical is recalling 90 TruCustom Pacemaker Pack convenience kits because they may contain loose polypropylene foreign material in the included needles.
Cook Inc. is recalling 615 units of Mallinckrodt Institute Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.
Oakworks Inc. is recalling foot controls for specific medical imaging tables because they can become lodged under the table base or column.
Avid Medical is recalling 597 TruCustom Ortho Tray kits because they may contain needles with loose polypropylene foreign material.
Otto Bock is recalling 75 Kenevo knee joints due to a design issue that could cause the pylon to break under specific heavy-use conditions.
Ethicon is recalling 25 lots of VICRYL RAPIDE suture because the material failed knot tensile strength testing during quality control.
Zimmer Biomet is recalling 38,879 units of the 2nd Assist Knee Positioner because the sterile packaging barrier may be breached during distribution.
AngioDynamics is recalling 28 Soft-Vu Omni Flush Angiographic Catheters because they were distributed before required post-sterilization release activities were completed.
Accord Media, LLC is recalling 524 Ultra Renew devices distributed nationwide because they use an unapproved green LED light to treat hyperpigmentation.
Zimmer Biomet is recalling 3,350 units of the Segmental System, ZSS Distal Femur, because the products exceeded tested weights, potentially compromising the sterile barrier.
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