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.
Medtronic is recalling Solera Awl Tip Tap surgical devices due to incorrect laser marking. Thirteen devices were distributed in Florida, Colorado, Indiana, South Carolina, Texas, and Utah.
Medtronic is recalling InterStim Self-Adhesive Ground Pad (lot 60347246) due to incorrect expiration date labeling. Affected units were distributed internationally including to Iran.
Olympus revised labeling for the OER-Mini endoscope reprocessor. The company removed LF-V and LF-P endoscopes from the list of compatible devices and updated sterilization procedures.
The Impella RP Flex cardiac pump has been recalled due to a higher-than-expected rate of blood clot formation. Blood clots may reduce cardiac support or cause hemolysis.
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.
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.
A latching mechanism in the ACROBAT-i Vacuum Stabilizer System may fail during cardiac surgery, potentially causing loss of heart stabilization or device component release. The defect affects 334 units distributed worldwide.
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.
Olympus Corporation is recalling Always-On Tip Tracked Instruments due to a malfunction in the electromagnetic sensor that impairs navigation functionality during bronchoscopic procedures. The malfunction could result in procedural delays.
GE OEC field upgrade kits for fluoroscopy systems may have image intensifiers that detach during movement, potentially falling and causing injuries.
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 has recalled approximately 29,277 procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall covers kits distributed worldwide from April 2020 to April 2023.
Medline Industries recalls 146,157 custom procedural kits distributed April 2020 to April 2023 because the sterile ultrasound gel component may not meet sterility specifications.
Medline is recalling 6,340 custom sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications, creating contamination risk in surgical applications.
Scican has recalled 3 STATCLAVE G4 tabletop autoclaves due to risk of incomplete sterilization if used with incompatible loads. Healthcare facilities should verify only compatible materials are sterilized.
Medline Industries is recalling 144 custom procedural kits containing Turkuaz Ultrasound Gel because the sterile gel component may not meet required sterility specifications.
Medline is recalling pediatric electrophysiology procedural kits because the ultrasound gel component may not meet sterility specifications. The recall affects 192 kits distributed worldwide from April 2020 to April 2023.
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.
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.
A latch defect in the ACROBAT V Vacuum Off-Pump System may prevent proper heart stabilization during cardiac surgery. Maquet Cardiovascular recalled 594 units distributed worldwide.
Medline is recalling 15,323 custom sterile and non-sterile procedural kits worldwide due to potential non-sterility of the Turkuaz ultrasound gel component. Kits were distributed between April 2020 and April 2023.
Medline Industries is recalling custom procedural kits because the ultrasound gel component may not meet sterility specifications. The kits were distributed nationwide and internationally from 2020 to 2023.
Medline is recalling 233,638 procedural kits containing Turkuaz ultrasound gel that may not meet sterility specifications. The potentially non-sterile gel could pose infection risks during medical procedures.
Johnson & Johnson is recalling 61 TECNIS Eyhance intraocular lenses that may have been manufactured with unintended toric fiducial marks, which could affect proper surgical positioning. The affected units were distributed to China, India, and Korea.
Olympus SPiN Drive Forceps are being recalled due to an electromagnetic sensor malfunction that disables navigation functionality during endobronchial procedures, potentially causing procedural delays. No injuries reported.
Looking for a different category? Browse all recalls.