HUNTLEIGH Disposable Intraoperative Probe recalled for detachable faceplate
Huntleigh Healthcare Ltd. is recalling 150 HUNTLEIGH Disposable Intraoperative Probes (8MHz) because the faceplate may become detached from the probe body during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with a potential structural defect. While the hazard involves risk of malfunction during intraoperative use and no injuries have been reported, the device is used in surgical procedures where malfunction could impact patient care, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Huntleigh Healthcare Ltd. is recalling 150 HUNTLEIGH Disposable Intraoperative Probes (8MHz) distributed to healthcare facilities in Oklahoma, California, Georgia, Michigan, and Virginia. The faceplate may become detached from the probe body during use.
The recalled devices are identified by lot numbers 7842006001 (boxes containing 10 probes) and 784006001 (individual probes), with corresponding UDI codes 05051968036537 and 05051968036544.
This is a Class II recall issued by the U.S. Food and Drug Administration under recall number Z-0960-2022.
The recalled product
- Product
- HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
- Manufacturer
- Huntleigh Healthcare Ltd.
- Hazard
- Affected units
- 150
Distribution
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