Physio-Control, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1102-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

LIFEPAK 35 ECG cable REF 11111-000041

Product Classification:

Class II

Date Initiated: January 21, 2025

Date Posted: February 12, 2025

Recall Number: Z-1102-2025

Event ID: 96048

Reason for Recall:

Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions

Status: Ongoing

Product Quantity: 245 units

Code Information:

Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224

Distribution Pattern:

U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI, MO, NE, NV, NY, OH, OR, SC, TN, TX, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated