PlainRecordsFDA · Medical device recall
AD-TECH Spencer Probe Depth Electrode… and 2 more products
- Date
- Oct. 30, 2024
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Completed
- Filed by
- Ad-Tech Medical Instrument Corporation
- 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.
- Distribution pattern
- US Nationwide distribution in the states of CA, OH.
3 products in this recall
AD-TECH Spencer Probe Depth Electrode…
- Product
- AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
- Quantity
- 2 units
- Codes and lots
- UDI/DI 00841823107510, Lot Number 170052 858859860
- Recall started
- Sept. 19, 2024
- Device type
- Electrode, Depth
- Root cause (FDA)
- Employee error
- What the company told customers
- 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 number
- Z-0219-2025
AD-TECH Spencer Probe Depth Electrode…
- Product
- AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
- Quantity
- 4 units
- Codes and lots
- UDI/DI 00841823107589, Lot Number 169260 858859860, 169258 858859860
- Recall started
- Sept. 19, 2024
- Device type
- Electrode, Depth
- Root cause (FDA)
- Employee error
- What the company told customers
- 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 number
- Z-0220-2025
AD-TECH Spencer Probe Depth Electrode…
- Product
- AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
- Quantity
- 14 units
- Codes and lots
- UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881
- Recall started
- Sept. 19, 2024
- Device type
- Electrode, Depth
- Root cause (FDA)
- Employee error
- What the company told customers
- 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 number
- Z-0221-2025
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0219-2025, Z-0220-2025, Z-0221-2025. The agency record governs; check it and the company before acting.