FDA Device recall Z-2164-2021
Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no
- FDA Device
- Class II
- ongoing
- Published 2021-08-04
On 2021-08-04 the FDA classified a Class II recall of Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no by Innovative Tomography Product, citing sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2164-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-21 |
| Published | 2021-08-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Innovative Tomography Product |
| Distribution | US |
Product
Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm); Article no. BIM 14/10, Length 100 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/15, Length 150 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/20, Length 200 mm, Diameter 14 G (2.1 mm) *NOT DISTRIBUTED WITHIN THE US
Reason
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Identifiers
| code_info | Affected Lot Numbers: BIM 18/10: LOT: 4918; BIM 18/15: LOT: 4017, 4918, 4719; BIM 18/20: LOT: 4017, 4918; BIM…Affected Lot Numbers: BIM 18/10: LOT: 4918; BIM 18/15: LOT: 4017, 4918, 4719; BIM 18/20: LOT: 4017, 4918; BIM 16/10: LOT: 4918, 1119, 1219; BIM 16/15: LOT: 4918, 1119; BIM 16/20: LOT: 4918, 1119; BIM 14/10: LOT: 4918, 3019; BIM 14/15: LOT: 4918; BIM 14/20: LOT: 4918 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2164-2021%22
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