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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 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.
Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.
Universal Meditech Inc. is recalling the DiagnosUS SARS-CoV-2 Antibody Test because the devices were distributed without marketing authorization and the manufacturer cannot verify manufacturing compliance or post-market safety oversight.
American Contract Systems is recalling CVS PCSU SJH IV catheter and adhesive components due to improper ethylene oxide sterilization. The components may have reduced functionality or elevated chemical residuals.
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.
Multiple diagnostic test products recalled due to company closure and inability to provide manufacturing and quality control documentation.
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.
Medtronic is recalling 77 units of Grafton DBM (Flex) due to a potential failure to perform required inspection of the outer Tyvek sterile pouch. Affected units may not meet sterile packaging standards.
Smith & Nephew recalled 28 JOURNEY II knee prosthesis inserts because two different articular types were mislabeled and swapped during packaging. The incorrect labeling prevents identification of the actual insert type.
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.
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.
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.
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.
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.
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.
Access Vascular is recalling HydroPICC Dual Lumen Catheter kits with incorrect instruction documents that omit critical warnings about adult-only use and vessel sizing. No adverse events have been 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.
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.
A software bug in Functional MR V1.0 can cause file contents and descriptions to not match when exporting multiple regions of interest in DICOM format, potentially leading to misinterpretation of clinical imaging data.
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.
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.
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.
Cardinal Health is recalling Monoject tuberculin syringes because the conical tip is incompatible with certain needleless IV connectors.
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