injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with… — Class II medical device recall Z-1478-2023
Ongoing recall by Labories Medical Technologies, reported 2023-05-10. The packaging may be damaged, compromising the sterile barrier.
| Recall number | Z-1478-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Labories Medical Technologies, Portsmouth, NH, United States |
| Recall initiated | 2023-02-07 |
| Classified | 2023-04-28 |
| Reported by FDA | 2023-05-10 |
| Quantity | 415,480 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00627825000017, 00627825000024 |
| Lot numbers | D197765, D198592, D198638, D199716, D19B105, D19B106, D19B109, D19C094, D19C097, D19C098, D19C742, D19C743, D19C788, D19C789, D201620, D201666, D201667, D202622, D202623, D203778, D203779, D203780, D203783, D204100, D204101, D204597, D204598, D205440, D205441, D205442, D205443, D205444, D205445, D205446, D207081, D207082, D207623, D207624, D208579, D208580 and 69 more |
| Model numbers | DIS199, DIS201 |
Product
injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
Reason for recall
The packaging may be damaged, compromising the sterile barrier.
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-1478-2023. 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.