TRITON recallZ-1402-2022 · Stryker Instruments Div. of Stryker Corporation · initiated Jan 22, 2020
Class II Terminated
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 Instruments Div. of 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
Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.
FDA root cause category: Process control
What the company is doing
Customers were notified via email dated 1/22/20. We request the following actions from you: 1. Please confirm receipt of this communication by emailing myself and/or your Gauss representative. 2. Please identify any of these miscolored Canister Scanning Labels in your possession: " Find the the miscolored labels by locating any package of insert + scanning label with a date of manufacture prior to to 2019-12-24. See an example below: 3. Once identified, please: " Quarantine this product and indicate this has been completed by written email response to this communication Your Gauss representative will be in contact with you this week to help resolve this issue. Replacement product will be provided immediately. Thank you for your attention to this matter. Please feel free to reach out directly to me if you have any questions.
Recall details
- Recall number
- Z-1402-2022
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 22, 2020
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 16,700 units
- Product code
- PBZ
- FDA submissions
- K142801
- Distribution
- US Nationwide
Product description
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.
Code information (models, lots, serial numbers)
UDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- TRITON FG-12010Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss2 recalls0 reports
- Triton Canister System FG-12009Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss2 recalls0 reports
Product lines
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 18, 2026. Text above is shown as published by the FDA.
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