Coaxial Interventional Needle — Class II medical device recall Z-2162-2021
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-2162-2021 |
|---|---|
| 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 | 0217, 0220A, 0220B, 0220C, 0418, 0717, 0817, 0920, 1020, 1118, 1220, 13/04T, 13/09T, 13/14T, 14/20T, 1417, 15/04T, 15/09T, 15/14T, 16/04T, 16/09T, 16/14T, 18/10, 18/10T, 18/15, 18/15T, 18/20, 20/10, 20/15, 2118, 2119, 22/05, 22/07, 22/10, 22/15, 2419, 2420, 2720, 2818, 3416 and 14 more |
Product
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G (0.7 mm); Article no. KIM 20/15, Length 150 mm, diameter 20 G (0.9 mm); Article no. KIM 18/10, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/10T, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15, Length 150 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15T, Length 150 mm, diameter 18 G (1.25 mm); Article No. KIM 18/20, Length 200 mm, diameter 18G/1.27mm, Article no. KIM 13/04T, Length 44 mm, diameter 13 G (2.40 mm); Article no. KIM 13/09T, Length 94 mm , diameter 13 G (2.40 mm); Article no. KIM 13/14T, Length 144 mm, diameter 13 G (2.40 mm); Article no. KIM 15/04T, Length 44 mm, diameter 15 G (1.95 mm); Article no. KIM 15/09T, Length 94 mm, diameter 15 G (1.95 mm); Article no. KIM 15/14T, Length 144 mm, diameter 15 G (1.95 mm); Article no. KIM 16/04T,Length 44 mm, diameter 16 G (1.60 mm); Article no. KIM 16/09T, Length 94 mm, diameter 16 G (1.60 mm); Article no. KIM 16/14T, Length 144 mm, diameter 16 G (1.60 mm); Article no. KIM 14/20T, Length 200 mm, Diameter 14 G (2.1 mm)
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-2162-2021. 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.