Mizuho Doppler Probe Recalled Due to Sterile Barrier Penetration
Vascular Technology, Inc. is recalling 147 Mizuho Doppler Probes because the sterile barrier was penetrated, potentially rendering the devices unsterile.
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: The recall involves a medical device where the sterile barrier was compromised, creating a risk of infection or harm. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Vascular Technology, Inc. is recalling 147 units of the 07-150-10 Mizuho Doppler Probe, Slim, BX 4, Ref 138660. The recall was initiated after a report that the product penetrated the sterile barrier, which could render the product unsterile.
The affected devices are intended for the intraoperative and transcutaneous evaluation of blood flow. The recall covers units distributed worldwide, including the United States (specifically California), Australia, the United Kingdom, and Taiwan. The specific lot number for the recalled units is 11802-37667.
Healthcare providers and facilities should stop using the affected devices and contact Vascular Technology, Inc. for instructions on return or replacement.
The recalled product
- Product
- 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
- Manufacturer
- Vascular Technology, Inc.
- Affected units
- 147
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 (1)
- LOT NUMBER 11802-37667
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Vascular Technology, Inc. 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 4 products in this recall →Related recalls
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