CIVCO Needle Guide — Class II medical device recall Z-2946-2018
Terminated recall by Civco Medical Instruments Co. Inc., reported 2018-09-05. The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive t
| Recall number | Z-2946-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Civco Medical Instruments Co. Inc., Kalona, IA, United States |
| Recall initiated | 2018-07-30 |
| Classified | 2018-08-29 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2020-09-16 |
| Countries outside the US | AT, BE, CH, DE, DK, ES, FR, GB, PL |
| Quantity | 107 units |
| UPC / GTIN / UDI-DI | 00841436107327 |
| Lot numbers | A018067, A021026, A021226, A022447, A023876, A025137, A02560, A025606, A026609, A026610, A028159, A028645, A029293, A029383, A032036, A033139, A033153, A035009, A035010, A035568, A037150, A037231, A037585, A039417, A040376, A040839, A041444, A041723 |
| Model numbers | 676-144 |
Product
CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
Reason for recall
The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
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-2946-2018. 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.