Class II — Civco Medical Instruments Inc
| Recalling firm | CIVCO Medical Instruments Co., Inc. |
|---|---|
| Registered facility | CIVCO Medical Instruments Co., Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Leaks were detected in the recalled lot which may compromise the sterility of the product. |
| 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. |
| Quantity | 120 pouches |
| Distribution | Distributed to the states of CA, IL, MA, MI, MO, and WI. |
| Initiated | 2015-02-26 |
| Classified | 2015-04-08 |
| Terminated | 2017-02-28 |
| Recall number | Z-1400-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Civco Medical Instruments Inc (Z-1400-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70719/
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