Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation — Class II medical device recall Z-2241-2026
Ongoing recall by Medtronic Neuromodulation, reported 2026-06-03, distributed nationwide. A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
| Recall number | Z-2241-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2026-05-13 |
| Classified | 2026-05-28 |
| Reported by FDA | 2026-06-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, ES, FR, GB, IT, JP, LV, NL, PL, SE |
| Quantity | 31 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00643169090866, 00643169936584, 00763000963040, 00763000968427, 00763000968434, 00763000968441 |
| Lot numbers | 0231367316, 0231367317, 0231493884, 0231493885, 0231494066, 0231928923, 0231929188, 0231929189, 0231929192, 0231980220, 0231980221, 0231980222, VA3347Y, VA33481, VA33M8V, VA33M92, VA33T31, VA33T33, VA35B5D, VA35B5E, VA35TTU, VA35TTV, VA35WSP, VA35WSU, VA368FZ, VA368G3, VA36V7T, VA36V8Q |
| Model numbers | 64002 |
Product
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
Reason for recall
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2241-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.