CIVCO Needle Guide Bracket — Class II medical device recall Z-0562-2019
Terminated recall by CIVCO Medical Instruments Co., Inc., reported 2018-12-19. The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembl
| Recall number | Z-0562-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CIVCO Medical Instruments Co., Inc., Coralville, IA, United States |
| Recall initiated | 2018-11-02 |
| Classified | 2018-12-07 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2020-11-20 |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CY, DE, DK, EE, ES, FR, GB, HK, HR, IL, IN, IT, JP, LB, LT, LV, NL, NZ, PH, PL, PT, QA, RO, SA, SG, TR, TT, TW, UA, ZA |
| Quantity | 738 boxes |
| Reason classes | sterility |
| Model numbers | M001457100, P03122-08, P06013-10 |
Product
CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
Reason for recall
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
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-0562-2019. 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.