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.
Boston Scientific's AXIOS Stent Delivery System is being recalled because the outer sheath can detach during use, preventing proper stent expansion and requiring device exchange.
Percussionaire Corporation is recalling VDR4 Phasitron breathing circuit models due to a venturi component that may stick and reduce ventilation. This Class I recall affects over 4,700 units worldwide.
Microvention is recalling Lot #0000629846 of the Headway 17 Advanced Straight Microcatheter due to incomplete seals in inner packaging that could compromise sterility. The affected lot was distributed outside the U.S.
Trinity Sterile is recalling Wolf-Pak Dressing Change Kits (lot #600018) due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
Specific lots of BD PCR Cartridges used with the MAX System may experience signal drift, potentially affecting diagnostic accuracy. BD has initiated a recall of 516,435 affected units worldwide.
Olympus is recalling the Thunderbeat surgical hand instrument because the probe tips are being damaged or breaking. The recall affects 34,325 units distributed in the US and internationally.
Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.
Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
Trinity Sterile is recalling Dressing Change Kits with ChloraPrep and HaloGUARD due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed across multiple states.
O&M HALYARD is recalling HALYARD Laparotomy Packs due to elevated residues of anti-block/slip additives found in the sterile packaging. These surgical instruments were distributed nationwide.
Jinan Bodor Cnc Machine Co Ltd is recalling 269 units of Bodor P and C series laser cutting machines distributed nationwide due to non-compliance with FDA standards.
Baxter Healthcare is recalling specific lots of its Solution Set with Duo-Vent Spike due to inverted side clamps that may render the tubing unusable. The affected product was distributed nationwide.
Baxter Healthcare is recalling specific lots of Clearlink System Solution Sets with inverted clamps that render the tubing unusable. The affected units are distributed nationwide in eight U.S. states.
Olympus Corporation is recalling Olympus Thunderbeat front-actuated surgical hand instruments (Model TB-0535FCS) due to damaged or breaking probe tips and pad detachment. Approximately 128,608 units distributed outside the US are affected.
Olympus is recalling approximately 9,200 units of Thunderbeat surgical hand instruments distributed worldwide because probe tips can become damaged, break, or pads can detach during use.
The Merlin.net Heart Failure monitoring application cannot transmit patient readings after a data migration to a cloud environment. Some systems (25 total) distributed across 13 U.S. states are affected.
BD Pyxis MedStation 4000 medication dispensers are recalled due to drawer and door failures that may delay medication access. The recall affects 13,055 units distributed worldwide.
St. Jude Medical recalled 431 CardioMEMS HF pressure measurement systems after a cloud data migration reverted systems to outdated configuration, causing inaccurate pulmonary artery pressure readings.
Olympus recalls 54,500 Thunderbeat surgical hand instruments due to probe tips that may be damaged or break. These sterile devices are used in ultrasonic surgical procedures.
Olympus is recalling Thunderbeat hand instruments because probe tips can be damaged or break, and pads can detach during use. No injuries have been reported.
Olympus is recalling the Thunderbeat 5 mm surgical hand instrument due to damaged or broken probe tips and pads. The defect may affect surgical function and device performance.
The VITROS 3600 Immunodiagnostic System may not properly alert users when Signal Reagent Packs expire, risking use of expired products and potentially inaccurate test results. Affected systems worldwide should be checked for this software issue.
Randox Laboratories is recalling 33 Randox Lipoprotein (a) diagnostic kits nationwide. The assay's claims for use on Roche Cobas c501 analyzers lack required FDA clearance or approval.
Olympus has recalled Thunderbeat surgical hand instruments because the probe tips can become damaged or broken, including pad damage and detachment. The recall affects 36,712 units distributed internationally outside the United States.
CareFusion 303, Inc. is recalling 5 units of the BD Pyxis Med 4000 Auxiliary medication dispensing system due to drawer and door failures that may delay access to medications. Three failure modes identified: door latch failure, cable ribbon damage, and magnet falling out.
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