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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.
Advance Medical Designs is recalling 50-GEL20 ultrasound gel (13,750 units, lot 21043C2328) due to mislabeling with inappropriate use instructions. The product was distributed in the US, Canada, UK, Panama, and the Netherlands.
Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters due to a potential defect in the OSL material. Affected devices may provide radiation exposure readings outside the specified +/-5.5% accuracy range.
Advance Medical Designs is recalling 117,875 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The recall affects kits distributed to the United States, Canada, United Kingdom, Panama, and Netherlands.
Keystone Industries recalls Copaliner Cavity Varnish after discovering bottles of Copaliner Solvent were accidentally packaged in boxes labeled as varnish. The error affected 337 units distributed worldwide.
Landauer is recalling 211,815 nanoDot D2DNS radiation dosimeters worldwide. Some units may be outside the specified ±5.5% accuracy range due to a defect in the optical material, potentially resulting in inaccurate radiation exposure measurements.
Baxter Healthcare is recalling the Welch Allyn Connex Spot Monitor due to improper placement of copper tape on the back of the liquid-crystal display. The device was distributed in California.
Microbiologics Inc is recalling one lot of KWIK-STIK ANA QC sets missing one of three bacterial strains required for microbiological testing.
Philips 3D9-3v Transducer units may separate at the chassis bonding, risking electric shock and tissue damage if safety systems fail. Affected units distributed worldwide.
Philips recalls Azurion imaging systems because the foot switch pedal may stick in the active position, causing unintended radiation emission. Facilities should stop using the systems and contact Philips for guidance.
Philips MultiDiagnost-Eleva imaging systems may emit unintended radiation if the foot pedal gets stuck in the active position. The FDA is alerting healthcare facilities to this potential equipment malfunction.
Philips Allura Xper X-ray imaging systems are being recalled because the foot switch pedal may become stuck in the active position, potentially causing unintended radiation emission. The recall affects 5,432 systems distributed nationwide.
Aomori Olympus recalls 1,252 reusable distal attachment devices with DEHP chemical levels exceeding safe exposure limits per medical device standards. Devices distributed nationwide in the United States.
PARAGON VISION SCIENCES is recalling 18,820 Fargo Ortho-K contact lenses because they were manufactured without required FDA approval. Patients should contact their eye care provider.
Aesculap trocars manufactured with shafts too long obstruct the visual field when used with neuroendoscopes in brain surgery. Affected units distributed in nine states should not be used.
Paragon Vision Sciences is recalling 83,542 ISee Ortho-K lenses because the manufactured product lacks FDA approval coverage. This is a Class II recall.
Cook Vandergrift is recalling approximately 15,951 Cook Lead Clipper devices due to potential sterility compromise from packaging seal breaches. The surgical tool is used for cardiac lead retrieval procedures.
Aomori Olympus Co., Ltd. recalls 1,048 Olympus Distal Attachment units used in EMR kits due to di-2-ethylhexyl phthalate (DEHP) exceeding permissible exposure limits per ISO 10993-17: 2002. Devices were distributed nationwide.
Zimmer, Inc. is recalling M/L Taper Hip Prosthesis implants where the outer package labeling and product etch do not match the actual implant size. This mislabeling could lead to implantation of the wrong-sized prosthesis.
ZVU Functional GI Software labeled as revision 3.3.0 is incorrectly labeled; it actually contains revision 3.2.0. The mislabeling affects 20 units distributed from May to July 2023.
Datascope is recalling Cardiosave Hybrid intra-aortic balloon pumps due to reported temperature alarms that can cause loss of pumping function or unexpected standby mode. Users have reported these system failures in critical cardiac support devices.
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to system overheating alarms that can cause loss of pumping function and device shutdown.
Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps due to autofill failures that can cause the pump to stop.
Datascope Corp. is recalling Cardiosave Hybrid intra-aortic balloon pumps due to autofill failure causing pump stops. The FDA Class I recall affects approximately 9,175 units distributed nationwide.
Olympus Corporation recalls 6,426 units of the EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to recent reports of patient infections. The device was distributed nationwide in the United States.
Datascope Corp. is recalling approximately 9,175 Cardiosave Rescue IABPs because unexpected gas-loss and gas-gain alarms may occur during therapy due to patient movement, blood in the circuit, and hardware issues.
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