Finished Goods Box of 50 Inserts and Scanning Labels for… recallZ-1185-2023 · Stryker Corporation · initiated Jan 25, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

Stryker issued Urgent Medical Device Correction letter to Risk Manager, OR Director, Materials Manager dated Jan 25, 2023. Letter states reason for recall, health risk and action to take: Steps: 1. Immediately check your internal inventory to locate any affected Finished Goods Inserts and Scanning labels (FG 12010 and FG 12022). Quarantine and discontinue use of all affected products. 2. A Stryker representative will contact your facility to assist updating the Triton Canister software. 3. Return the enclosed Business Reply Form (BRF) even if you don t have any affected product on hand, via email to [email protected]. 4. If the BRF indicates that recalled product is currently on hand, a shipping label will be provided to return recalled product. Upon receipt of the recalled product, Stryker will arrange replacements. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Contact: Sylvia Page | Stryker Instruments Recall Coordinator 269-501-8375 |[email protected]

Recall details

Recall number: Z-1185-2023
Status: Open, Classified
Initiated by the company: Jan 25, 2023
Posted by the FDA: Feb 27, 2023
Recalling firm: Stryker Corporation
Quantity: 541 units
Product code: PBZ
FDA submissions: K142801
Distribution: US Nationwide distribution.

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Triton Canister System FG-12009
Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss
2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 91578).

Z-1184-2023 · Open, Classified
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.
Z-1186-2023 · Open, Classified
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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