Ad-Tech Medical Recalls Subdural Electrodes Due to Incorrect MR Safety Labeling
Ad-Tech Medical Instrument Corporation is recalling subdural electrodes because supplemental information incorrectly stated they were approved for use in MRI environments.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a labeling error that could lead to unsafe use in an MRI environment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ad-Tech Medical Instrument Corporation is recalling Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, and Wyler Subdural Electrodes. The recall involves 187,666 devices distributed nationwide and worldwide. The specific issue is that supplemental information provided with the devices incorrectly indicated that the subdural electrodes, depth electrodes, and anchor bolts were approved for use in the MR environment, when they are not approved for such use.
The recall covers all catalog numbers and lot numbers distributed through May 30, 2019. The devices were distributed to all 50 US states, DC, Puerto Rico, and numerous international locations including Canada, the United Kingdom, and Australia.
Healthcare facilities and consumers should stop using these devices in MRI environments. Users should contact Ad-Tech Medical Instrument Corporation for further instructions on how to handle the affected devices.
The recalled product
- Product
- Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Hazard
- Affected units
- 187,666
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All catalog numbers and lot numbers distributed through May 30
- 2019
Distribution
Part of a larger recall action
This product is one of 3 recalled by Ad-Tech Medical Instrument Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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