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Ring Transjugular Intrahepatic Access Sets, Reference Par... (Cook Incorporated) – laceration hazard (2025)

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

Moderate

FDANov 26, 2025Nationwide• Cook Incorporated

Brand Name: Mastisol Liquid Adhesive Product Name: Liquid... (Ferndale Laboratories, Inc.) – butyrate tube cracks during actuation... (2025)

Butyrate tube cracks during actuation, rendering product unusable.

Moderate

FDANov 25, 2025Nationwide• Ferndale Laboratories, Inc.

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Ring Transjugular Intrahepatic Access Sets, Reference Par... (Cook Incorporated) – laceration hazard (2025)

Brand Name: Mastisol Liquid Adhesive Product Name: Liquid... (Ferndale Laboratories, Inc.) – butyrate tube cracks during actuation... (2025)

Brand Name: Alcon Laboratories, Inc. Product Name: Custom... (Alcon Research LLC) – ophthalmic procedure packs may have i... (2025)

Zimmer Dermatome AN, Model/Catalog Number: 88710100 (Zimmer Surgical Inc) – the devices may have a misaligned thi... (2025)

LifeShield Drug Library Management (DLM), LifeShield Infu... (ICU Medical, Inc.) – software issue only allows concentrat... (2025)

Zimmer Air Dermatome, Model/Catalog Number: 00880100100 (Zimmer Surgical Inc) – the devices may have a misaligned thi... (2025)

Draeger Vapor 2000. Unheated, calibrated anesthetic vapor... (Draeger, Inc.) – a certain component of affected devic... (2025)

Draeger Vapor 3000. Unheated, calibrated anesthetic vapor... (Draeger, Inc.) – a certain component of affected devic... (2025)

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fix... (Smith & Nephew, Inc.) – removal of affected lot of screws due... (2025)

LifeShield Drug Library Management (DLM); LifeShield Infu... (ICU Medical, Inc.) – for certain customers, the change sum... (2025)

The Elecsys Anti-TSHR immunoassay is a three-step competi... (Roche Diagnostics Operations, Inc.) – issues identified: 1) results vary by... (2025)

Medline Hudson RCI Medium Concentration Oxygen Masks: ... – firm received multiple complaints reg... (2025)

Restore Clinician Programmer Application (CP App), Model ... (Medtronic Neuromodulation) – software issue where a device reset m... (2025)

BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation E... (CareFusion 303, Inc.) – automated dispensing cabinets (adc) r... (2025)

Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Ca... (Vortex Surgical Inc.) – reason for the voluntary recall is so... (2025)

AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 705... (Steris Corporation) – wire connected to the electrical box ... (2025)

AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 70... (Steris Corporation) – wire connected to the electrical box ... (2025)

Hardware configuration of the BeneVision Central Monitori... (Mindray DS USA, Inc. dba Mindray North America) – when the worstation of the benevision... (2025)

HemosIL SynthAFax. Partial Thromboplastin Time Tests. (Instrumentation Laboratory) – recalled lots were manufactured with ... (2025)

Intelerad InteleShare software, with ProViewer component (DICOM Grid, Inc.) – software intended to aid in diagnosin... (2025)