Home / Recalls / Medtronic Xomed, Inc. / Z-1520-2022

Z-1520-2022 Class I Ongoing

Recalled by Medtronic Xomed, Inc. — Jacksonville, FL

FDA device recall Z-1520-2022 was initiated by Medtronic Xomed, Inc. on April 29, 2022 and is designated Class I. Reason for recall: The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. The recall status is ongoing. Affected quantity: 1,133,612 units.

Recall Details

Product Type: Devices
Report Date: September 7, 2022
Initiation Date: April 29, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,133,612 units

Product Description

NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306

Reason for Recall

The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

Distribution Pattern

Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kosovo, Kuwait, Libya, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, North Macedonia, Northern Mariana Islands, Norway, Oman, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam

Code Information

a) REF 8229308; UDI 00643169789548, 00763000745837, 00763000882402; ALL LOTS. b) REF 8229307; UDI 00643169789531, 00763000745820, 00763000882396; ALL LOTS. c) REF 8229306; UDI, 00643169789524, 00763000745813, 00763000882389; ALL LOTS.

Other recalls by Medtronic Xomed, Inc.

Z-2461-2025 Class II — IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. Th (July 17, 2025)
Z-1623-2025 Class II — NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; (March 10, 2025)
Z-3130-2024 Class II — Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 (July 5, 2024)
Z-2409-2024 Class I — NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vi (June 24, 2024)
Z-0696-2024 Class II — NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 822970 (November 7, 2023)
Z-1224-2022 Class II — NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 (May 3, 2022)
Z-1223-2022 Class II — NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 (May 3, 2022)
Z-1519-2022 Class I — NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 (April 29, 2022)
Z-1521-2022 Class I — NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) (April 29, 2022)
Z-0743-2022 Class II — NIM TRIVANTAGE EMG Endotracheal Tube (December 22, 2021)