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.
Philips Medical Systems is recalling 165 CT 5300 scanners on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.
ICU Medical is recalling 875 single-unit ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Beckman Coulter is recalling 108 CellMek SPS sample preparation systems because the instructions for use list incorrect dead volumes and the software does not rock Cassette E.
ICU Medical is recalling 11,000 administration sets with a 20-drop integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.
Alcon Research is recalling 82 units of PRECISION1 One-Day Contact Lenses in -2.25D because some units may have a weak seal that compromises sterility.
Aesculap is recalling 26 sealing units for 10/12mm trocars with reducer because silicone fragments may detach from the yellow sealing component.
Alcon Research is recalling 330 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
ICU Medical is recalling 1,600 6-inch extension sets with MicroClave Clear and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 200 73-inch smallbore extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 134,700 ChemosafeLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Siemens Healthcare Diagnostics is recalling 3,318 units of the IMMULITE 2000 Intact PTH assay over the potential for falsely depressed patient results at the low end of the assay range.
Medistim is recalling 14 MiraQ ultrasound systems because insufficient soldering in the Printer Support Module may loosen wires and cause the system to shut down.
Alcon Research is recalling 1,632 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Surgical Theater is recalling 19 units of its EndoSNAP platform because a software anomaly may misalign secondary image layers against the primary layer.
ICU Medical is recalling 2,000 bulk non-sterile ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.
CareFusion is recalling 8,262 BD Pyxis Medbank units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.
Surgical Theater is recalling 14 units of its SyncAR SNAP platform because a software anomaly may misalign secondary image layers against the primary layer.
ICU Medical is recalling 3,000 ChemoLock Bag Spikes with Clave additive port because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 11,000 31-inch administration sets with an integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.
Cepheid is recalling 4,132 Xpert SA Nasal Complete kits after post-market half-time stability testing produced a false negative result for a positive sample type.
ICU Medical is recalling 133,255 ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 53,050 ChemoLock 20mm Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 200 60-inch smallbore extension sets with a ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 3,350 ChemoLock 13mm Closed Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Endomagnetics is recalling 1,760 Magseed Pro 7 cm soft tissue markers because of the potential for contamination with cotton fibers.
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