Lower riskMedical device recall · FDA · Published January 22, 2020
Stryker Triton Canister Scanning Labels Recall: Blood Loss Estimation Risk
Stryker recalls Triton Canister Scanning Labels made before Dec 2019 due to potential underestimation of blood loss during surgery. Affected labels have specific part numbers and manufacturing dates.
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.
Take action
Contact the company
📍Recalling firmStryker Instruments Div. of Stryker Corporation4100 E Milham Ave · Portage, MI 49002-9704
“Stryker Triton Canister Scanning Labels Recall: Blood Loss Estimation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65960-stryker-triton-canister-scanning-labels-recall-blood-loss-estimation-risk. Based on FDA recall #Z-1402-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1402-2022%22&limit=1).
The FDA announced on Jan. 22, 2020, that Stryker Instruments recalled Triton Canister System Scanning Labels due to color variance that may cause lower-than-expected blood loss estimates. The recall affects labels manufactured before Dec. 24, 2019.
How to tell if you have it
Triton Canister System Scanning Label (finished part numbers FG 12009 for 3L canisters and FG 12019 for 2L canisters; component part number 11032)
UPC 10859506006101
UPC 10859506006125
Date of manufacture prior to 2019-12-24
The hazard
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 labels may result in lower than expected results.
Context
GovInfoNow's records show Stryker Instruments Div. of Stryker Corporation has 11 other recalls on record since 2017-10-16. Other recent recalls include the 2022-06-15 Stryker SurgiCount+ Software Version 2.0.17 recall for duplicate sponge counting error risk, the 2020-10-16 Stryker Zyphr Disposable Cranial Perforator recall for crack risk during surgery, and the 2020-03-26 Stryker Neptune E-SEP 165mm Blade Electrode recall due to expired product. Other recent recalls of similar products include the 2026-05-25 Medtronic Pediatric Cannula Recall for loose blood material risk, the 2026-04-10 Stryker BARD Dynamic Tip Steerable Recall for incomplete sterile seals risk, and the 2026-04-10 Stryker BW Webster Duo-Decapolar Catheter Recall for incomplete sterile seals.
How to tell if you have this one
Check for scanning labels with part numbers FG 12009 (3L canisters) or FG 12019 (2L canisters) made before December 24, 2019. The labels have a UDI-DI GTIN: 10859506006101 or 10859506006125.
Brand
Stryker
Product
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Label Date
Look for scanning labels with a date of manufacture prior to December 24, 2019.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1402-2022 (January 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1402-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.