CLASS II ONGOING Device recall · Reported 8 Mar 2023 · FDA Enforcement Report
Finished Goods Box of 50 Inserts and Scanning Labels recalled by Stryker
Stryker is recalling Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian, distributed nationwide in the US. The recall was initiated on 25 Jan 2023 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-1184-2023
- FDA event ID
- 91578
- Recalling firm
- Stryker, Portage, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jan 2023
- FDA classified
- 27 Feb 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 25 Jan 2023 | Recall initiated by company | |
| 27 Feb 2023 | Classified by FDA | +33 days |
| 8 Mar 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian recalled?
Yes. Stryker recalled Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian on 25 Jan 2023. The recall is Class II and its status is Ongoing. Recall number Z-1184-2023.
Why was it 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.
Which lots are affected?
UDI-DI: 10859506006125 Lot Numbers: M2110004, M2201002, M2202001, M2203002, M2206001
Where was it sold?
US Nationwide distribution.
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 21 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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