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Showing 1–20 of 67 results

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Integra LifeSciences Corp. (NeuroSciences): Codman Microsensor Basic Kit. Catalog Number: 626631US. ...

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

FDADec 12, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

Integra LifeSciences Corp. (NeuroSciences): Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826...

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

FDADec 12, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

IMPRIS Imaging Inc: Brand Name: HFD100 Product Name: Head Fixation Device HF...

Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.

FDADec 8, 2025Nationwide• IMPRIS Imaging Inc

Meridian Bioscience Inc: Revogene C. difficile, in vitro diagnostic assay intended...

The affected lots show a decline in performance over time, which may lead to false-negative results.

FDADec 5, 2025Nationwide• Meridian Bioscience Inc

CareFusion 303, Inc.: BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 13...

Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

FDADec 3, 2025Nationwide• CareFusion 303, Inc.

Zimmer, Inc.: Brand Name: Affixus Antegrade Femoral Nailing System Prod...

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

FDADec 2, 2025Nationwide• Zimmer, Inc.

Microbiologics Inc: LYFO DISK, Campylobacter jejuni subsp. jejuni derived fro...

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

FDADec 2, 2025Nationwide• Microbiologics Inc

Microbiologics Inc: KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni deri...

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

FDADec 2, 2025Nationwide• Microbiologics Inc

Microbiologics Inc: KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni deri...

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

FDADec 2, 2025Nationwide• Microbiologics Inc

Ferndale Laboratories, Inc.: Brand Name: Mastisol Liquid Adhesive Product Name: Liquid...

Butyrate tube cracks during actuation, rendering product unusable.

FDANov 25, 2025Nationwide• Ferndale Laboratories, Inc.

Zimmer Surgical Inc: Zimmer Air Dermatome, Model/Catalog Number: 00880100100

The devices may have a misaligned thickness control bar.

FDANov 24, 2025Nationwide• Zimmer Surgical Inc

Zimmer Surgical Inc: Zimmer Dermatome AN, Model/Catalog Number: 88710100

The devices may have a misaligned thickness control bar.

FDANov 24, 2025Nationwide• Zimmer Surgical Inc

Alcon Research LLC: Brand Name: Alcon Laboratories, Inc. Product Name: Custom...

Ophthalmic procedure packs may have incomplete seals affecting sterility.

FDANov 24, 2025Nationwide• Alcon Research LLC

Roche Diagnostics Operations, Inc.: The Elecsys Anti-TSHR immunoassay is a three-step competi...

Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.

FDANov 21, 2025Nationwide• Roche Diagnostics Operations, Inc.

Medtronic Neuromodulation: Restore Clinician Programmer Application (CP App), Model ...

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.

FDANov 20, 2025Nationwide• Medtronic Neuromodulation

Steris Corporation: AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 705...

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

FDANov 19, 2025Nationwide• Steris Corporation

Vortex Surgical Inc.: Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Ca...

Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

FDANov 19, 2025Nationwide• Vortex Surgical Inc.

Steris Corporation: AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 70...

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

FDANov 19, 2025Nationwide• Steris Corporation

AVID Medical, Inc.: Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST01...

Potential for incomplete seal on header bag.

FDANov 14, 2025GA, IL, MD +1 more• AVID Medical, Inc.

AVID Medical, Inc.: Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.

Potential for incomplete seal on header bag.

FDANov 14, 2025GA, IL, MD +1 more• AVID Medical, Inc.

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