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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.
Boston Scientific is recalling 461 POLARSHEATH Steerable Sheath devices due to a manufacturing tooling error that may cause inner sheath delamination and potential fragment release during medical procedures.
Fresenius is recalling 663,221 stay-safe Luer Lock catheter extension units nationwide due to chemical leachables (NDL PCBAs) identified in the tubing.
InfuTronix is recalling Nimbus Infusion Pump Systems (Nimbus Flex, Nimbus PainPro) due to potential battery failure, system errors, drug leakage, flow rate abnormalities, and housing damage. About 52,328 units are affected nationwide.
Fresenius Medical Care is recalling 105,700 stay-safe /Luer Catheter Extension 6 in devices nationwide due to chemical leachables identified in the peroxide cross-linked tubing. FDA classified this as a Class I recall.
Fresenius is recalling 479,978 stay-safe Luer Lock Catheter Extensions due to chemical leachables in the tubing. Healthcare providers should contact the manufacturer for replacement information.
Fresenius Medical Care is recalling 114,982 stay-safe Safe Lock Catheter Extensions due to peroxide cross-linked tubing leachables. Patients and healthcare providers are advised to discontinue use and contact the manufacturer for replacement.
Emergency Products & Research is recalling 190,000 O.T.D. traction splints because adhesive may fail to secure the pole insert, potentially compromising function in emergency medical situations.
Boston Scientific recalls certain batches of OptiCross Coronary Imaging Catheters manufactured with an incorrect voltage setting that may cause decreased image brightness.
Alcon is recalling bulb irrigation syringes due to potential sterile barrier compromise in surgical procedure packs. Non-sterile syringes may increase infection risk.
Medivance Inc. is recalling Neonatal ArcticGel Pads due to reduced water flow that may prevent proper heating or cooling performance in neonatal temperature management systems. No injuries have been reported.
Olympus recalls InstaClear Lens Cleaner devices due to inconsistencies between Japanese and English instruction manuals that could cause component separation during endoscopic procedures.
Puritan Medical Products distributed HydroFlock Sterile Flocked Collection Devices labeled as Part Number 25-3317-H, Lot S1014 that actually contain product code 25-3317-U. Approximately 232,500 units were affected.
Olympus recalled 3,172 UHI-4 insufflation units due to the front panel LED turning off, which causes loss of air supply. All serial numbers nationwide are affected.
Bruder Healthcare is recalling MediBeads King Pad moist heat compresses (item numbers 34120, 34120PM, 34125R) from certain lots due to potential mold and mildew growth from excessive moisture exposure.
Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load a clip after the trigger is actuated, potentially impacting surgical procedures.
Bio-Rad Laboratories is recalling a diagnostic test kit due to incorrect calibrations and controls that may produce inaccurate test results. Patients and healthcare providers should contact the manufacturer.
Hologic is recalling 684 kits of the Aptima CMV Quant Assay diagnostic test; when used with plasma specimens, the assay may generate error codes that invalidate test results. Lot number 402941 is affected.
Bolton Medical Inc. is recalling 21 RELAY PRO Thoracic Stent-Graft Systems because the stent-graft inside the delivery system is the incorrect size.
Olympus Corporation recalls the SOLTIVE Pro SuperPulsed Laser (TFL-SLS) due to a non-compliant power cord with incompatible plug configurations for the regions where affected units were distributed.
Bruder Healthcare Company is recalling Thermalon Stye Compress (Item Number 24352) in certain lots due to potential mold and mildew growth from excessive moisture exposure. No illnesses have been reported.
Baxter is recalling specific lot codes of Supple Peri-Guard Repair Patch because endotoxin levels may exceed limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.
Certain lots of Thermalon Back Wrap may have been exposed to excessive moisture, potentially resulting in mold and mildew growth. The product is distributed nationwide in the US and Canada.
Bruder Healthcare Company is recalling certain lots of Thermalon Sinus Compress due to potential mold and mildew growth from moisture exposure. The product was distributed in the US and Canada.
Bruder Healthcare Company is recalling 1,416 units of Thermalon Sinus Compress (Item Number 24332) due to potential mold and mildew growth from excessive moisture exposure. Affected lot numbers are M053160 and M053570.
Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control test results.
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