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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Cepheid Xpert® BCR-ABL Ultra diagnostic test kits are being recalled because specimens with elevated white blood cell counts (>30,000 cells) may produce inaccurate test results. The recall affects 4,032 units distributed across the US and internationally.
AVID Medical is recalling 240 units of Halyard EP LAB Pack (Catalog ESJH009-03) due to potential incomplete seals on header bags. The affected lot was distributed to facilities in Georgia, Illinois, Nebraska, and Maryland.
Fresenius Medical Care is recalling 115 units of the 5008X CAREsystem dialysis device due to software anomalies that could interrupt patient treatment. The defect may cause the device to stop operating under certain conditions.
Rocket Medical is recalling 246 units of the Rocket 20Fg Seldinger Catheter Procedure Tray due to misleading labeling and instructions that could lead to improper device securing and potential dislodgement during clinical use.
Cepheid recalls 6,325 Xpert BCR-ABL Ultra test kits due to potential inaccuracies when samples contain elevated white blood cell counts. The diagnostic test is used to monitor chronic myeloid leukemia.
DSAART LLC is recalling AART Chin Implants because they were manufactured with deviations from specifications and distributed without required FDA premarket approval.
Medline is recalling sterile Kelly forceps (Item DYNJ04048) distributed in CA, CO, IL, KS, and MI. Weak packaging seals may compromise sterility, increasing the risk of infection if the product is used.
Intelerad InteleShare medical imaging software versions 3.24.3–3.25.2 contain a bug causing inaccurate measurement values when multiplanar reconstruction and manual rotation are used together. This could compromise diagnostic accuracy and potentially lead to misdiagnosis.
DSAART LLC recalls 41 AART Pectoral Implants distributed without FDA approval and manufactured outside specifications. Units affected in multiple US states.
DSAART LLC is recalling 118 AART Gluteal Implants distributed across US states due to specification deviations and lack of required FDA premarket approvals. Patients should contact their surgeon.
AVID Medical recalls Halyard General Laparoscopy Pack due to potential incomplete seals on the header bag that could compromise product sterility.
DSAART LLC is recalling AART Malar Implants due to manufacturing deviations and lack of FDA premarket approval. No illnesses or injuries have been reported.
Smith & Nephew is recalling BIOSURE HA Screws (6MM x 20MM bone fixation fasteners) due to a labeling error. The recall affects 168 units distributed in the US and internationally.
Zimmer Surgical Inc is recalling 498 Zimmer Dermatome AN surgical instruments due to a potential misaligned thickness control bar that could affect device accuracy during use.
Abbott is correcting software in Alinity ci-series chemistry analyzers (versions 3.6.1 and lower) that could produce erroneous results for multiple analytes. The issue was discovered during internal testing.
Copan Italia is recalling 122,850 units of DTT treatment reagent used in respiratory specimen processing. The reagent's functionality in specimen fluidification cannot be guaranteed.
Instrumentation Laboratory recalls HemosIL SynthAFax Partial Thromboplastin Time Tests (4,506 units) due to a manufacturing defect where recalled lots contained double the intended amount of preservative.
Datascope Corp. is recalling the Cardiosave Rescue. An addendum to the Instructions for Use corrects the reference standards for vibration and shock.
Datascope Corp. is updating the Instructions for Use for the Cardiosave Hybrid to correct standards references in the Vibration and Shock Table. Approximately 11,470 units have been distributed in the US and internationally.
Draeger's ErgoStar CM 55 airway connectors are being recalled due to cracks forming in the catheter mount hose. The defect affects respiratory connectivity in mechanical ventilation systems used for critically ill patients.
Draeger is recalling 14,420 ErgoStar CM 40 airway connectors worldwide due to cracks forming in the connector hose, which could compromise respiratory gas delivery to mechanically ventilated patients.
Draeger, Inc. is recalling the ErgoStar CM 60 airway connector (Model MP01860) due to multiple reports of cracks forming in the hose, which could lead to disconnection of the device from the patient during mechanical ventilation.
Draeger, Inc. is recalling ErgoStar CM 45 airway connectors due to cracks in the hose that may compromise respiratory gas delivery. Approximately 191,470 units are affected worldwide.
Medline is recalling Quick Strip Fabric Sterile Adhesive Bandages due to open seals in packaging that may compromise sterility. Approximately 6.9 million units distributed in the US, Guam, Canada, and UAE are affected.
Medline is recalling all lots of Quick Strip Fabric Sterile Adhesive Bandages because open packaging seals may compromise product sterility. The recall affects 11,291,800 units.
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