HUNTLEIGH Disposable Intraoperative Probe (Huntleigh Healthcare) – Faceplate Detachment (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
Brand
Huntleigh Healthcare Ltd.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Number: (10) 7842006001 UDI: (01) 05051968036537 (10) 784006001 (individual) UDI: (01) 05051968036544 (10) 784006001 (box)
Huntleigh Healthcare Ltd. is recalling HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposab due to Faceplate may become detached from the probe body.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Faceplate may become detached from the probe body.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026