FDA Medical Device Recalls (openFDA)
Ad-Tech Medical Instrument Corporation: AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
- Recall number
- Z-0221-2025
- Recalling firm
- Ad-Tech Medical Instrument Corporation
- Product
- AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
- Status
- Completed
- Initiated
- 2024-09-19
- Posted
- 2024-10-24
- Terminated
- not on file
- Reason
- Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
- Root cause
- Employee error
- Action
- AD-TECH issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 09/19/2024. The notice explained the problem with the devices, risk to health, and requested the consignee contact customer support to obtain an RMA to expedite the return of the affected product. For questions: contact your Ad-Tech Clinical Specialist.
- Quantity
- 14 units
- Distribution
- US Nationwide distribution in the states of CA, OH.
- Lot, serial or model codes
- UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881
- 510(k) numbers
- ["K163355"]
- PMA numbers
- not on file
- Product code
- GZL
- Firm FEI
- 2183456
- Firm city
- Oak Creek
- Firm state
- WI
- Firm country
- not on file
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