FDA Medical Device Recalls (openFDA)
Technomed Europe: NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
- Recall number
- Z-3131-2024
- Recalling firm
- Technomed Europe
- Product
- NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
- Status
- Open, Classified
- Initiated
- 2024-07-25
- Posted
- 2024-09-12
- Terminated
- not on file
- Reason
- Product has have presence of brown discoloration or substance on the hinge area of the device
- Root cause
- Process control
- Action
- Technomed Europe issued a FIELD SAFETY NOTICE to its consignees on 07/25/2024 via email. The notice explained the issue, potential risk, and requested the cessation of distribution and quarantine of the affected product pending return of the affected product. Distributors were directed to notify those to whom the product was distributed by forwarding a copy of the notice.
- Quantity
- 71 units
- Distribution
- US: FL, CA, TX, IL, NY, PA, MA
- Lot, serial or model codes
- UDI/DI 08718375869659, Lot Numbers: 061158, 061380
- 510(k) numbers
- ["K110422"]
- PMA numbers
- not on file
- Product code
- ETN
- Firm FEI
- 3001450493
- Firm city
- Maastricht-Airport
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28