Medtronic Clip Gun Magazines are packaged in individually sealed… — Class II medical device recall Z-3212-2018
Terminated recall by Medtronic Neurosurgery, reported 2018-10-03, distributed in AL, AR, AZ, CA, CO, DC, FL, GA…. The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized
| Recall number | Z-3212-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neurosurgery, Goleta, CA, United States |
| Recall initiated | 2018-05-03 |
| Classified | 2018-09-21 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2022-08-30 |
| Distributed | AL, AR, AZ, CA, CO, DC, FL, GA, IA, ID, IL, IN, KS, LA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | AU, DE, KE, ZA |
| Quantity | 2,616 |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 20643169647200 |
| Lot numbers | 54984, 57188, 59558, 66312, 67988 |
| Model numbers | CM8902 |
Product
Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use
Reason for recall
The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if package has been previously opened or damaged , it is possible that the seal breach may go undetected by the user's naked eye.
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-3212-2018. 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.