CIVCO lnfiniti Needle Guide Bracket — Class II medical device recall Z-2888-2018
Terminated recall by Civco Medical Instruments Co. Inc., reported 2018-08-29, distributed nationwide. A cover failed leak testing during validation testing of new needle guides from a replacement tool.
| Recall number | Z-2888-2018 |
|---|---|
| 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 | 2018-02-23 |
| Classified | 2018-08-22 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2020-10-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CH, CN, DE, DK, ES, GB, HK, IT, JP, NL, UA |
| Quantity | 177 boxes |
| Reason classes | packaging |
| Lot numbers | M119380, M206950, M358570, M427660, M526300, M543670, M570610, M605540, M664690, M706720, M734570, M851530, M897110, M912740, M983170 |
| Model numbers | 620-116, 639-026, 698-009, 698-016 |
Product
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
Reason for recall
A cover failed leak testing during validation testing of new needle guides from a replacement tool.
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-2888-2018. 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.