Biopsy Needle FPU Kit — Class II medical device recall Z-0659-2020
Ongoing recall by Medtronic Navigation, Inc., reported 2019-12-18, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exis
| Recall number | Z-0659-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2019-10-30 |
| Classified | 2019-12-06 |
| Reported by FDA | 2019-12-18 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BR, CA, CH, CN, CO, CR, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, HR, HU, ID, IE, IL, IN, IS, IT, JO, JP, KE, KR, LB, LU, LV, MX, MY, NL, NZ, PH, PK, PL, PT, QA, RO, RS, SA, SE, SI, SK, TH, TR, ZA |
| Quantity | 1 disposable |
| UPC / GTIN / UDI-DI | 00763000063108 |
| Lot numbers | 0009754921, 0009921273, 0009921274, 0009921276, 0009940846, 0009952564 |
Product
Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
Reason for recall
The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.
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-0659-2020. 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.