Medtronic Xomed, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1224-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2

Product Classification:

Class II

Date Initiated: May 3, 2022

Date Posted: June 8, 2022

Recall Number: Z-1224-2022

Event ID: 90163

Reason for Recall:

Software anomaly was identified.

Status: Ongoing

Product Quantity: 29 units

Code Information:

Model Number: NIM4CPB1; UDI/DI: 00763000002985, lot numbers: P1910256, P1910260, P1910402, P1910404, P2008073, P2008130, P2008131 and 00763000395902, lot numbers: P2026275, P2026290, P2026329, P2026330, P2026357, P2026388, P2026389, P2026680, P2026681, P2026718, P2026719, P2026793, P2026956, P2026957, P2026958, P2026959, P2026981, P2026994, P2026995, P2127005, P2127006, P2127013

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.

Voluntary or Mandated:

Voluntary: Firm initiated