Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 4, 2019
AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the
An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial d…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ad-Tech Medical Instrument Corporation recalled AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (De… - a moderate-severity action.
AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (De… was recalled by Ad-Tech Medical Instrument Corporation in September 4, 2019. Reason: An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an…. Check the official notice for the remedy. Verify recall #Z-2396-2019 with the FDA Devices before acting.
The recall
Ad-Tech Medical Instrument Corporation issued this moderate-severity FDA Devices recall-An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an….
- Moderate
- severity level
- 18 units
- affected scope
- Class II
- classification
- September 4, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2396-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2396-2019) was formally reported on September 4, 2019, with the manufacturer initiating the action on April 16, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Ad-Tech Medical Instrument Corporation is listed as the recalling firm, operating out of Oak Creek, WI. Federal records list the affected scope as 18.
The documented reason for this recall is: An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation… Distribution data in the federal record shows the product reached: Worldwide - Nationwide distribution in the state of Illinois and countries of Russia and United Kingdom. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
18
Related Recalls
6
3 from same agency
Product description
AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Reason for recall
An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes (SD08R-SP05X-000) were in fact 6 contact depth electrodes (SD06R-SP05X-000) . There was no impact to the patient due to this incident.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2396-2019 |
| Date reported | September 4, 2019 |
| Date initiated | April 16, 2019 |
| Recalling firm | Ad-Tech Medical Instrument Corporation |
| Firm location | Oak Creek, WI |
| Affected scope | 18 |
| Distribution | Worldwide - Nationwide distribution in the state of Illinois and countries of Russia and United Kingdom |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2396-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.. Recalled by Ad-Tech Medical Instrument Corporation. Units affected: 18.
Why was this product recalled? ▼
An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes (SD08R-SP05X-000) were in fact 6 contact depth electrodes (SD06R-SP05X-000) . There was no impact to the patient due to this incident.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2019. Severity: Moderate. Recall number: Z-2396-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide - Nationwide distribution in the state of Illinois and countries of Russia and United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2396-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 4, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.