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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.
GE OEC 9900 fluoroscopy systems' image intensifiers can detach during movement if subjected to large impact force, potentially falling and causing injuries such as fractures or bruising.
Medline Industries recalls 1,130 anesthesia procedural kits over concerns that the sterile ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide including the US from April 2020 to April 2023.
Medline Industries is recalling 130 custom procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.
Medline Industries is recalling sterile procedural kits containing ultrasound gel that may not meet sterility specifications. The kits were distributed worldwide between April 2020 and April 2023.
Medline is recalling 1,231,480 Probe Cover Kits distributed worldwide due to potential sterility specification failures in the ultrasound gel component.
Philips Allura Xper FD10 and FD20 X-ray systems may have loose or broken bolts supporting the FlexMove Carriage and cracks in the suspension rail. Affected units distributed worldwide; users should inspect equipment and contact manufacturer.
Medline is recalling 41,123 procedural kits containing ultrasound gel that may fail to meet sterility specifications. The kits were distributed to healthcare facilities worldwide between April 2020 and April 2023.
Philips Azurion 7 M20 X-ray imaging systems may have loose or broken carriage support bolts and cracks in the suspension rail. The Class II recall affects 648 units distributed worldwide.
Zimmer Periarticular Locking Plates have a thread form defect that prevents surgical screws from properly mating with the plate. 75 units distributed across multiple U.S. states and internationally.
GE OEC field upgrade kits for fluoroscopy systems may have image intensifiers that detach during movement, potentially falling and causing injuries.
Olympus recalls SPiN Drive histology needles due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.
Medline Industries is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel because the gel component may not meet sterility specifications. The kits are distributed worldwide for dialysis procedures.
The ACROBAT SUV blade may not latch securely onto its activator drive during use. This could prevent heart stabilization during surgery, cause positioning loss, or release device components into the patient.
Medline recalled 134,514 custom surgical procedural kits due to potential sterility failure in the Turkuaz Ultrasound Gel component. The affected kits were distributed worldwide from April 1, 2020 through April 28, 2023.
The ACCESSRAIL Platform Standard Blade may fail to latch securely, potentially causing loss of heart stabilization or device component release into patients during cardiac surgery.
Medline is recalling sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications. Approximately 6,939 kits were distributed between April 2020 and April 2023.
Medline has recalled 63,823 custom procedural kits due to potential sterility specification failure of the ultrasound gel component. The affected kits were distributed worldwide from April 2020 through April 2023.
Covidien is recalling certain Cytosponge Cell Collection Devices and Kits because the sponge may detach from the string during removal, potentially causing device fragments, obstruction, and aspiration in patients.
Always-On Tip Tracked Instruments forceps (Model INS-0362) may experience electromagnetic sensor tracking malfunction during endobronchial procedures, impairing navigation functionality and causing procedural delays.
A metal mounting box in the Incisive CT scanner may become expelled, potentially injuring users or causing the system to shut down. Philips is recalling 20 affected units distributed internationally.
Medline Industries is recalling 148,445 procedural kits containing Turkuaz Ultrasound Gel over potential sterility failure of the gel component, which could lead to infections if used in sterile procedures.
Olympus Corporation recalls the Always-On Tip Tracked Triple Needle Brush due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.
Medline recalls 4,618 custom sterile procedural kits distributed worldwide from April 2020 through April 2023. The Turkuaz ultrasound gel component may not meet sterility specifications, posing a potential infection risk in surgical procedures.
Johnson & Johnson is recalling 42 TECNIS Symfony intraocular lenses that may have been manufactured with unintended toric fiducial marks. The lenses are surgical implants used to restore vision.
Medline Industries is recalling 211 custom procedural kits (egg retrieval, fetal surgery, TVT packs) worldwide because the sterile ultrasound gel component may not meet sterility specifications. Kits were distributed between April 2020 and April 2023.
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