FDA Medical devices recall ·
AD-TECH Spencer Probe Depth Electrode recall
- Recall number
- Z-0219-2025
- Date
- (initiated September 19, 2024)
- Company / brand
- Ad-Tech Medical Instrument Corporation
400 W Oakview Pkwy, Oak Creek, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 2 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 00841823107510, Lot Number 170052 858859860
Distribution
US Nationwide distribution in the states of CA, OH.
States: California Ohio
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0219-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.