CollectEVAC — Class II medical device recall Z-2558-2014
Terminated recall by Civco Medical Instruments Inc, reported 2014-09-03, distributed in AZ, IL, LA, MA, MD, MI, MN, MO…. A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility
| Recall number | Z-2558-2014 |
|---|---|
| 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 | 2014-08-01 |
| Classified | 2014-08-28 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2015-01-28 |
| Distributed | AZ, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, SD, TN, VA, WI |
| Countries outside the US | BR |
| Quantity | 52 kits |
| Reason classes | sterility, packaging |
| Lot numbers | M423010, M426580, M430200, M431710, M431760 |
| Model numbers | 610-954 |
Product
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery.
Reason for recall
A pinhole leak identified in the packaging of the recalled product potentially could 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-2558-2014. 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.