HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF… recallZ-0960-2022 · Huntleigh Healthcare Ltd. · initiated Feb 11, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Huntleigh Healthcare Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Faceplate may become detached from the probe body.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm notified their consignees by email beginning on 02/11/2022. The notice explained the issue and requested disposal of the probes on site. Distributors were directed to notify their customers. The firm will replace the affected probes.
Recall details
- Recall number
- Z-0960-2022
- Status
- Terminated
- Initiated by the company
- Feb 11, 2022
- Recalling firm
- Huntleigh Healthcare Ltd.
- Quantity
- 150 devices
- Product code
- ITX
- FDA submissions
- K201425
- Distribution
- US Nationwide distribution in the states of OK, CA, GA, MI, VA.
Product description
HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
Code information (models, lots, serial numbers)
Lot Number: (10) 7842006001 UDI: (01) 05051968036537 (10) 784006001 (individual) UDI: (01) 05051968036544 (10) 784006001 (box)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DOPPLEX DIPP10Huntleigh Healthcare Limited · Transducer, Ultrasonic, Diagnostic1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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