Stryker Corporation: Medical Device Recall in 2023 - (Recall #: Z-1185-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.

Product Classification:

Class II

Date Initiated: January 25, 2023

Date Posted: March 8, 2023

Recall Number: Z-1185-2023

Event ID: 91578

Reason for Recall:

Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.

Status: Ongoing

Product Quantity: 541 units

Code Information:

UDI-DI: 10859506006101 Lot Numbers: M2112001, M2112003, M2202001, M2203001, M2204001, M2205001, M2206002

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated