Reported Apr 27, 2022 · Terminated

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

Huntleigh Healthcare Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Huntleigh Healthcare Ltd. · 35 Portmanmoor Road · Cardiff · N/A

Is this the product you have?

  • HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
Lot codes and dates
  • Lot Number(10) 7842006001
  • UDI(01) 05051968036537 (10) 784006001 (individual)
  • UDI(01) 05051968036544 (10) 784006001 (box)
Amount recalled
150 devices

Where it was sold

Why it was recalled

Faceplate may become detached from the probe body.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 12, 2024 · Data as of Sep 19, 6:59 PM UTC

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