Semi-automatic Biopsy-Needle — Class II medical device recall Z-2164-2021
Ongoing recall by INNOVATIVE TOMOGRAPHY PRODUCT GMBH, reported 2021-08-04, distributed nationwide. Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
| Recall number | Z-2164-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | INNOVATIVE TOMOGRAPHY PRODUCT GMBH, Bochum, N/A, Germany |
| Recall initiated | 2021-04-21 |
| Classified | 2021-07-29 |
| Reported by FDA | 2021-08-04 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, sterility |
| Lot numbers | 1119, 1219, 14/10, 14/15, 14/20, 16/10, 16/15, 16/20, 18/10, 18/15, 18/20, 3019, 4017, 4719, 4918 |
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 for recall
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
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-2164-2021. 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.