Z-0960-2022Class II

HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable...

Name: Z-0960-2022 HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable...
Creator: Huntleigh Healthcare Ltd.
Published: 2022-02-11
License: https://open.fda.gov/license/

Huntleigh Healthcare Ltd. / initiated 2022-02-11 / Terminated

FDA source

Huntleigh Healthcare Ltd. began a recall of HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8 on 2022-02-11. FDA classified it as Class II and gives the reason as "Faceplate may become detached from the probe body". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0960-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-11
Posted: 2022-04-20
Terminated: 2024-06-12
Recalling firm: Huntleigh Healthcare Ltd.
Product: HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Faceplate may become detached from the probe body.
FDA 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 in commerce: 150 devices
Distribution: US Nationwide distribution in the states of OK, CA, GA, MI, VA.
Product codes and lots: Lot Number: (10) 7842006001 UDI: (01) 05051968036537 (10) 784006001 (individual) UDI: (01) 05051968036544 (10) 784006001 (box)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0960-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0960-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-27	2022-04-20

Product code ITX

K201425Class IIDisposable Intraoperative Probe (DIOP8)Huntleigh Healthcare Limited / cleared 2021-02-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)