Agency classClass IIOur severity:High FDA (Devices)·Z-1185-2023·Announced 2023-03-08

Medivac Guardian blood loss estimation device inserts may provide inaccurate readings

Stryker's Medivac Guardian 3L scanning labels may cause inaccurate blood loss estimates, potentially delaying treatment for postpartum hemorrhage. The recall affects 541 units distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm product—inaccurate blood loss estimates could delay critical treatment recognition. No reported illnesses, injuries, or deaths are documented. Per the rubric, risk-of-harm products without reported incidents score 3 (High).

Plain-English summary

Stryker Corporation is recalling Finished Goods Boxes containing 50 inserts and scanning labels for the Medivac Guardian 3L blood loss estimation device. The affected product has Catalog Number FG 12022, and 541 units have been distributed nationwide.

The device may produce inaccurate blood loss estimates. These inaccurate readings could lead to confusion and potentially result in delayed recognition of postpartum hemorrhage (PPH), prolongation of PPH, or requirement for more aggressive treatment of PPH.

Healthcare providers using the Medivac Guardian 3L should verify whether they have devices with the affected lot numbers: M2112001, M2112003, M2202001, M2203001, M2204001, M2205001, and M2206002. Contact Stryker Corporation with questions about the recall.

The recalled product

Product: Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.
Manufacturer: Stryker Corporation
Category: Medical Device — Obstetric / Blood Loss Estimation
Hazard: inaccurate-readings
delayed-recognition
hemorrhage-risk
Affected units: 541

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

UDI-DI: 10859506006101 Lot Numbers: M2112001
M2112003
M2202001
M2203001
M2204001
M2205001
M2206002

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Stryker Corporation

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Same hazard · inaccurate readings