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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.
Angiodynamics Inc. is recalling NAMIC Fluid Delivery Sets because they may not be sterile due to packaging errors.
Zimmer Biomet is recalling Repicci II Tibial Components for partial knee replacement because endotoxin levels exceeded process maximum limits.
Ion Beam Applications is recalling two Proteus 235 Proton Therapy Systems because users may restart aborted irradiations without selecting correct data.
CP Medical Inc is recalling PGCL absorbable sutures because they failed to meet USP tensile strength requirements over their shelf life.
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
BD Diagnostic is recalling BD Viper LT software version 3.00H because it generates lower-than-expected RFU values, which may impact test results.
Beckman Coulter is recalling Access Ferritin Calibrators because they contain a calibration card with an incorrect S5 calibrator concentration.
Avid Medical is recalling 25,308 Vacutainer tubes because an expired component was found in a kit with a later expiration date, leading to incorrect lot and expiration labeling.
Alcon is voluntarily removing 561,702 Patient Care Kits from the US market because the supplier reported potential sterile packaging compromise.
Smith & Nephew is recalling 100 units of D-RAD orthopedic screws because the expiration dates on the labels are incorrect and later than the actual expiration dates.
Verathon is recalling GVL 2 Stat blades (lot GC32825) because they were physically packaged with the incorrect size device, GVL 1 Stat blades.
Merge Healthcare is recalling Eye Station and Eye Care PACS software because antivirus programs may permanently delete newly captured medical images.
Smith & Nephew is recalling 197 units of D-RAD locking screws because the expiration dates on the labels are incorrect and later than the actual expiration dates.
Ferno-Washington Inc is recalling 34 units of the PROFlexx Model 28Z Chair Cot because an incorrect nut was used during manufacturing.
Siemens is recalling three Artis zee angiographic x-ray systems due to a software fault that prevents the system from initializing after a tube assembly failure.
Instradent USA is recalling 170 Neodent CM Intraoral Scanbodies because the body diameter is incompatible with CM Implants when positioned subcrestally.
Smith & Nephew is recalling 19 units of D-RAD locking pegs because the expiration dates on the labels are incorrect and later than the actual dates.
Zimmer Dental Inc is recalling 188 units of the Tapered SwissPlus Implant System because the internal thread diameter is below specification.
Smith & Nephew is recalling specific Peri-Loc VLP self-tapping cortex screws because the expiration dates printed on the labels are incorrect and later than the actual dates.
Ace Surgical Supply Co., Inc. is recalling 87 INFINITY Internal Hex Healing Abutments because the incorrect device was packaged.
Teleflex Medical is recalling Arrow EZ-IO Needle Sets because some individual unit pouches are missing lot numbers and expiration dates.
Volcano Corporation is recalling 718 Refinity Short Tip Rotational IVUS Catheters due to high complaint rates of kinking near the proximal shaft junction, which may disrupt clinical workflow or cause loss of imaging.
Welch Allyn is recalling 981 ProBP 2400 digital blood pressure devices due to a defective electrical component that may cause over-voltage battery charging and melting of plastic parts.
PerkinElmer is recalling 29 units of Specimen Gate Laboratory software due to a potential for errors in patient results. The software is used for processing laboratory data.
Draegar Medical Systems is recalling Delta XL patient monitors because the low oxygen alarm may fail to sound when oxygen levels drop below the limit.
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