Coaxial Interventional Needle — Class II medical device recall Z-2163-2021
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-2163-2021 |
|---|---|
| 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 | 0319, 0417, 0418, 0518, 0520, 0717, 0718, 0719, 0817, 0917, 0918, 1020, 1417, 1520, 1618, 1620, 2016, 21/10, 21/12, 21/15, 21/20, 2116, 2117A, 2117B, 2119, 23/05, 23/05N, 23/07, 23/07N, 23/10, 23/15, 2317, 2417, 2420, 2516, 2720, 2916, 3318, 3319, 3320 and 25 more |
Product
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07N, Length 70 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/10, Length 100 mm, Diameter 23G (0,6mm); Article no. KIR 23/15, Length 150 mm, Diameter 23 G (0.6 mm); Article no. KIR 21/10, Length 100 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/12, Length 120 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/15, Length 150 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/20, Length 200 mm, Diameter 21 G (0.8 mm); Article no. KIR 17/15, Length 150 mm, Diameter 17 G (1.40mm) Article no. KIR 17/15:45, Length 150 mm, Diameter 17 G (1.40mm) *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-2163-2021. 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.