Surgical Dissector Recalled for Brown Discoloration on Hinge Area
Technomed Europe is recalling NEUROSIGN Disposable Stimulating Dissectors due to brown discoloration or substance on the hinge area. The recall affects 71 units distributed across seven US states.
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 medical device recall with no reported illnesses or injuries. The hazard—brown discoloration or substance on the hinge—represents a potential risk to device functionality without documented adverse events, fitting the criterion for a risk-of-harm product without reported injury.
Plain-English summary
Technomed Europe is recalling NEUROSIGN Disposable Stimulating Dissectors, REF 5888-00, due to the presence of brown discoloration or substance on the hinge area of the device. The recall affects 71 units that were distributed to healthcare facilities in Florida, California, Texas, Illinois, New York, Pennsylvania, and Massachusetts.
The FDA classified this as a Class II recall. Affected units are identified by lot numbers 061158 and 061380.
Healthcare facilities and practitioners who have received this product should contact Technomed Europe for information regarding the recall, including options for return or replacement of affected units.
The recalled product
- Product
- NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
- Manufacturer
- Technomed Europe
- Affected units
- 71
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 08718375869659
- Lot Numbers: 061158
- 061380
Distribution
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