CIVCO Surgi-Tip Transducer Cover Sterile — Class II medical device recall Z-1400-2015
Terminated recall by Civco Medical Instruments Inc, reported 2015-04-15, distributed in CA, IL, MA, MI, MO, WI. Leaks were detected in the recalled lot which may compromise the sterility of the product.
| Recall number | Z-1400-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Civco Medical Instruments Inc, Kalona, IA, United States |
| Recall initiated | 2015-02-26 |
| Classified | 2015-04-08 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2017-02-28 |
| Distributed | CA, IL, MA, MI, MO, WI |
| Quantity | 120 pouches |
| Reason classes | sterility, packaging |
| Lot numbers | 2018.01, M591280, M612600 |
| Model numbers | 610-833 |
Product
CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.
Reason for recall
Leaks were detected in the recalled lot which may compromise the sterility of the product.
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-1400-2015. 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.