Spencer Probe Depth Electrode recallZ-0221-2025 · Ad-Tech Medical Instrument Corporation · initiated Sep 19, 2024
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ad-Tech Medical Instrument Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-0221-2025
- Status
- Completed
- Initiated by the company
- Sep 19, 2024
- Posted by the FDA
- Oct 24, 2024
- Recalling firm
- Ad-Tech Medical Instrument Corporation
- Quantity
- 14 units
- Product code
- GZL
- FDA submissions
- K163355
- Distribution
- US Nationwide distribution in the states of CA, OH.
Product description
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Code information (models, lots, serial numbers)
UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Spencer Probe Depth Electrode SD08R-AP58X-000Ad-Tech Medical Instrument Corporation · ELECTRODE, DEPTH1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 95414).
- Z-0219-2025 · CompletedAD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
- Z-0220-2025 · CompletedAD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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