FDA Medical Device Recalls (openFDA)
Huntleigh Healthcare Ltd.: HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
- Recall number
- Z-0960-2022
- Recalling firm
- Huntleigh Healthcare Ltd.
- Product
- HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
- Status
- Terminated
- Initiated
- 2022-02-11
- Posted
- not on file
- Terminated
- 2024-06-12
- Reason
- Faceplate may become detached from the probe body.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 150 devices
- Distribution
- US Nationwide distribution in the states of OK, CA, GA, MI, VA.
- Lot, serial or model codes
- Lot Number: (10) 7842006001 UDI: (01) 05051968036537 (10) 784006001 (individual) UDI: (01) 05051968036544 (10) 784006001 (box)
- 510(k) numbers
- K201425
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 1000589001
- Firm city
- Cardiff
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28