CLASS II Device recall · Reported 27 Jul 2022 · FDA Enforcement Report
Triton Canister System (finished part numbers FG recalled
Stryker Instruments Div. of Stryker is recalling Triton Canister System (finished part numbers FG 12009, for canisters, and FG 12019 for, distributed nationwide in the US. The recall was initiated on 22 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1402-2022
- FDA event ID
- 90464
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jan 2020
- FDA classified
- 19 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 22 Jan 2020 | Recall initiated by company | |
| 19 Jul 2022 | Classified by FDA | +909 days |
| 27 Jul 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI GTIN: 10859506006101, 10859506006125 All Canister Scanning Labels with a date of manufacture prior to to 2019-12-24
Where was it sold?
US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Centricity Enterprise Archive V2, V3, and V4 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Et Control recalled by Datex-Ohmeda | Datex-Ohmeda | Device Malfunction | Nationwide |