Z-0221-2025Class II

AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode

Name: Z-0221-2025 AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Creator: Ad-Tech Medical Instrument Corporation
Published: 2024-09-19
License: https://open.fda.gov/license/

AD-Tech Medical Instrument Corp. / initiated 2024-09-19 / Completed / root cause: manufacturing process

FDA source

Ad-Tech Medical Instrument Corporation began a recall of AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode on 2024-09-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0221-2025
Classification: Class II
Status: Completed
Initiated: 2024-09-19
Posted: 2024-10-24
Recalling firm: AD-Tech Medical Instrument Corp.
Product: AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Product code: GZL Electrode, Depth
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 14 units
Distribution: US Nationwide distribution in the states of CA, OH.
Product codes and lots: UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0221-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0219-2025	Class II	Completed	Voluntary: Firm initiated	2024-10-30	2024-10-24
Z-0220-2025	Class II	Completed	Voluntary: Firm initiated	2024-10-30	2024-10-24
Z-0221-2025	Class II	Completed	Voluntary: Firm initiated	2024-10-30	2024-10-24

Product code GZL

K163355Class IIDepth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation / cleared 2017-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)