Stryker Instruments Div. of Stryker Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Stryker Instruments Div. of Stryker Corporation
Lot Codes / Batch Numbers
UDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24
Products Sold
UDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24
Stryker Instruments Div. of Stryker Corporation is recalling Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canist due to Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estima. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026