FDA Device recall Z-0657-2020
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
- FDA Device
- Class II
- ongoing
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 by Medtronic Navigation, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0657-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-10-30 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Navigation |
| Distribution | 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 |
Product
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Reason
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.
Identifiers
| code_info | Lot Numbers: 66503918A 066513519A 066529218A 066535518A 66503919 066513519C 66531018 066512319A 066513519E 066531018A 066512319C 66529218 66535518 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0657-2020%22
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