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.
Ventana Medical Systems is recalling OptiView Amplification Kits due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling iView DAB IHC Detection Kits due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling OptiView Amplification Kits due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling 20 units of the ultraView SISH DNP Detection Kit due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling ultraView Universal DAB Detection Kits due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling 18 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.
Siemens Medical Solutions is recalling SOMATOM Go.Now CT system tables because bolts may loosen, causing the table to become unstable.
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.
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