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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.
Avid Medical is recalling 440 TruCustom Plastic Basin Packs because some kits contain needles with loose polypropylene foreign material.
Siemens Medical Solutions is recalling Axiom Artis devices due to a potential for liquid entry.
Fresenius Medical Care is recalling 15 hemodialysis machines due to a software error that causes a discrepancy between the displayed and actual ultrafiltration rates.
Philips is recalling Intellivue iX Information Center Software because restarting stations in 2018 prevents patient discharge and transfer operations, causing monitoring loss.
Avid Medical is recalling 70 TruCustom Pacemaker Tray kits because they may contain needles with loose polypropylene foreign material.
Tosoh Bioscience is recalling ST AIA-PACK Prog II assay kits because DHEA-S supplements can cause falsely elevated progesterone results.
Zevex Incorporated is recalling specific lots of Moog Curlin Infusion Administration Sets because particulate matter was found on the spike.
Aesculap Implant Systems LLC is recalling proSA Tool Sets because the adjusting pin does not set the correct valve opening pressure for the shunt system.
Avid Medical is recalling 12 TruCustom Laminectomy Kits because they may contain needles with loose polypropylene foreign material.
Zimmer Biomet is recalling 38,069 units of Versys 6 inch Beaded Full Coat Plus Hip Prostheses because weight issues may have compromised the sterile barrier.
Philips is recalling 1,486 Allura Xper FD and ORT X-ray systems because extra monitors mounted on the ceiling suspension may disengage and fall.
Accord Media, LLC is recalling 30 units of the Truth Renew device because it uses an unapproved green LED light to treat hyperpigmentation.
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.
Trumpf Medical Systems is recalling 212 surgical camera systems because their wireless receivers emit radiation above accepted limits, potentially interfering with other operating room devices.
Avid Medical is recalling 30 TruCustom SPINE convenience kits because they may contain loose polypropylene foreign material in the needles.
Accord Media is recalling 67 units of the Truth Renew Plus device because it uses an unapproved green LED light to treat hyperpigmentation.
Avid Medical is recalling obstetrical convenience kits because some contain needles with loose polypropylene foreign material above release specifications.
Avid Medical is recalling 120 TruCustom Lower Extremity convenience 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 medical devices.
Siemens Medical Solutions is recalling Artis Q and Q.Zen systems due to a potential for liquid entry.
Avid Medical is recalling 160 GYN laparoscopy kits because they may contain needles with loose polypropylene foreign material.
Tosoh Bioscience is recalling ST AIA-PACK Progesterone III Assay kits because cross-reactivity with DHEA-S supplements can cause falsely elevated test results.
Baxter Healthcare is recalling 2,800 units of 5 mL oral dispensers because the individual pouches are mislabeled with the wrong product code and volume.
Zimmer Biomet is recalling 885 Ziptight Ankle Syndesmosis Fixation Devices because they were packaged without tip protectors.
Steris Corporation is recalling 406 V-PRO 60 Low Temperature Sterilization Systems to update software that prevents the use of expired sterilant.
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