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.
Carl Zeiss OPMI LUMERA 300 surgical microscopes may have a missing screw on the suspension arm, potentially allowing suspended components to fall and injure nearby persons. Eight units distributed in Maryland, Texas, California, Georgia, and Louisiana are affected.
Universal Meditech Inc. is recalling diagnostic test strips due to Quality System violations and lack of manufacturing documentation. The company is closing and cannot provide post-market surveillance or support.
GE Healthcare Centricity Universal Viewer software versions 6.0 SP0-SP7.1 may combine radiological images from different patients into a single study, potentially affecting patient care and diagnosis.
A surgical navigation system used in ENT procedures may display incorrect curette tip positions, potentially causing delayed surgery, cerebrospinal fluid leaks, vision loss, or skull damage. The recall affects 141 units across 30 US states.
Two medical device components in the Robotics Pack (I.V. Cath and Adhesive Dermabond) were improperly sterilized and may lose functionality or drug efficacy. Affected units distributed in Florida and Iowa.
Medtronic is recalling Grafton Plus DBM Paste due to a missed inspection step on the outer packaging. The outer Tyvek pouch may have non-conformances that could affect product integrity.
Impedimed's SOZO Bilateral Arm L-Dex Software (versions 4.1 and 5.0) has inadequate sensitivity for detecting early lymphedema, which could delay treatment. The FDA is recalling 354 units distributed nationwide.
Omega Medical Imaging is recalling 52 monitor suspension systems (Part Number 1000-0085) manufactured 2012–2019 in which the actuator may separate from the pivot mechanism. An installed safety cable contained one such failure, but the structural issue poses a falling hazard. No injuries reported.
Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test because the company is going out of business and cannot verify manufacturing compliance or provide quality system documentation.
Smiths Medical is recalling 31,900 Portex Pro-Vent Arterial Blood Sampling Kits due to missing filter components. Kits without the filter can produce inaccurate test results or expose users to infectious blood.
American Contract Systems is recalling its Robotics Pack (56 cases) due to improper sterilization of IV catheter and adhesive components. The devices may have lost functionality or drug efficacy and may contain excessive ethylene oxide residuals.
Universal Meditech Inc. is recalling multiple diagnostic test strips (breastmilk alcohol, SARS-CoV-2 antibody, and ketone tests) distributed in the U.S. and Taiwan because the company is closing and cannot provide documentation of manufacturing compliance or post-market surveillance records.
Medtronic is recalling Grafton DBM Putty bone matrix implants because the outer Tyvek pouch inspection step may not have been performed, potentially releasing non-conforming batches.
Universal Meditech Inc. recalled DiagnosUS hCG pregnancy test strips because the company distributed them without FDA marketing authorization and cannot provide manufacturing compliance documentation. The firm is ceasing operations.
Empatica has recalled 1,360 units of its Embrace2 seizure monitoring wearable due to potential battery life lasting less than the specified 48 hours, requiring more frequent charging.
Medtronic is recalling specific serial numbers of Grafton DBM Matrix Strips due to a potential defect in the outer Tyvek pouch resulting from a missed inspection step during manufacturing.
Medtronic is recalling 377 units of Grafton DMB Matrix demineralized bone matrix devices due to potential defects in the outer Tyvek pouch from a missed manufacturing inspection step. No patient injuries have been reported.
Olympus recalls the UHI-4 High-Flow Insufflation Unit used in laparoscopic surgery after reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures. Incidents may result from over insufflation of the abdominal cavity.
Sapphire Infusion Pumps with software revisions 16.10.1 or 16.10.2 may fail to detect air in the infusion line, potentially causing life-threatening air embolism. Approximately 1,383 units have been distributed nationwide.
MEDLINE ReNewal Harmonic ACE+7 surgical shears may have incomplete seals on packaging trays. Approximately 18 units were distributed in the United States. Affected products should not be used.
Cardinal Health is recalling Monoject tuberculin syringes because the conical tip is incompatible with certain needleless IV connectors.
DeRoyal Industries is recalling 32 surgical procedure kits containing syringes with potentially damaged luer tips that could compromise the sterile packaging barrier. The kits were distributed in Pennsylvania.
One lot of Stryker Tornier Perform Reversed Glenoid Baseplate components was manufactured with incorrect 6mm spacers instead of 3mm, preventing proper assembly. The defect affects 30 units distributed across ten US states.
Access Vascular recalls HydroPICC 5Fr Dual Lumen Maximal Barrier Kits due to incorrect Instructions For Use missing warnings about adult-use only and vessel sizing risks. No adverse events reported.
North Coast Medical Inc is recalling the Gladiator Wrist & Thumb Orthosis because the thumb strap may contain latex that is not declared on the product label. People with latex allergies are at risk.
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