Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8

FDA Recall Z-0960-2022 · Posted None

Recalling FirmHuntleigh Healthcare Ltd.
Recall StatusTerminated
Product CodeITX
Date Initiated2022-02-11
Date Terminated2024-06-12
Product Quantity150 devices

Reason for Recall

Faceplate may become detached from the probe body.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of OK, CA, GA, MI, VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201425Disposable Intraoperative Probe (DIOP8)Huntleigh Healthcare Limited · 2021-02-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑