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.
Intersurgical Inc is recalling 46,450 Double Swivel Elbow airway connectors because the port may crack and leak.
Medacta USA Inc. is recalling specific lots of Humeral Anatomical Cementless Metaphysis implants because a dimensional condition may limit the insertion of the locking screw.
Avanos Medical is recalling Haylard Closed Suction Systems for neonates and pediatrics because the central lumen may be blocked, potentially preventing adequate suctioning of airway secretions.
Siemens Medical Solutions is recalling Cios Alpha mobile X-ray systems because a crack in the C-arm holder could compromise stability and lead to injury.
Implant Direct is recalling 274 IO Scan Adapters because a loose part could fall into a patient's mouth, posing a risk of aspiration or ingestion.
Aerolase Corporation is recalling 65 LightPod ERA lasers because they lack a required remote interlock connector, posing a potential safety hazard.
Intersurgical Inc is recalling 50,400 airway connectors because the swivel elbow port may crack and leak. The recall covers products distributed nationwide in the US.
Implant Direct Sybron Manufacturing is recalling 232 IO Scan Adapters because a loose part could fall into a patient's mouth, causing aspiration or ingestion.
Stryker is recalling Pin To Rod Couplings for the Hoffmann II Compact External Fixation System because they may fail to clamp the pin and rod as intended.
Intersurgical Inc is recalling 19,200 airway connectors because the swivel elbow port may crack and leak.
Aerolase Corporation is recalling 649 LightPod Neo Lasers nationwide because they lack a required remote interlock connector.
Abbott Medical is recalling 814 Fast-Cath Trio Hemostasis Introducer devices because they contain 12F components instead of the expected 14F size.
Cochlear Americas Inc. is recalling 50 units of Baha 5 Sound Processor Tamper Proof Battery Doors packaged with the incorrect component.
Nextremity Solutions is recalling 87 Stratum MDS Screws because they are 2mm shorter than the length indicated on the package label.
Nextremity Solutions is recalling 86 Stratum MDS Screws because the components are 2mm shorter than indicated on the package label.
Medical Action Industries is recalling 9,924 cases of medical convenience kits because the included saline solution may exceed USP pH requirements.
Nextremity Solutions is recalling 86 Stratum MDS Screws because they are 2mm shorter than the length indicated on the package label.
Baxter Healthcare is recalling One-Link Needle-Free IV Connectors because some units require higher-than-expected force to connect securely to standard Luer adapters.
Thoratec Corp. is recalling HeartMate 3 Mobile Power Units because excessive static electricity can cause unrecoverable power loss, potentially reducing blood flow from the left ventricular assist system.
Villa Sistemi Medicali is recalling seven Apollo DRF X-ray tables because the angulation chain may fail early due to metal fatigue.
Villa Sistemi Medicali is recalling one Apollo EZ X-ray table because the angulation chain may fail early due to metal fatigue.
Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 318,678 units distributed in the US and 35 other countries.
Carl Zeiss Meditec is recalling 151 PLEX Elite 9000 Swept-Source OCT devices because a design fault may expose operators to hazardous voltage when contacting the metal enclosure.
Medicrea International is recalling 210 polyaxial pedicle screws that are 50mm long instead of the labeled 45mm, posing a risk of nerve contact and postoperative pain.
Nucletron BV is recalling 383 Flexitron brachytherapy afterloader systems due to a component failure that may cause treatment interruption or incorrect source positioning.
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