Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 3, 2014
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.
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Civco Medical Instruments Inc recalled CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf rese… - a moderate-severity action.
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf rese… was recalled by Civco Medical Instruments Inc in September 3, 2014. Reason: A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility…. Check the official notice for the remedy. Verify recall #Z-2558-2014 with the FDA Devices before acting.
The recall
Civco Medical Instruments Inc issued this moderate-severity FDA Devices recall-A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility….
- Moderate
- severity level
- Class II
- classification
- September 3, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2558-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2558-2014) was formally reported on September 3, 2014, with the manufacturer initiating the action on August 1, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Civco Medical Instruments Inc is listed as the recalling firm, operating out of Kalona, IA. Federal records list the affected scope as 52 kits.
The documented reason for this recall is: A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
52 kits
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2558-2014 |
| Date reported | September 3, 2014 |
| Date initiated | August 1, 2014 |
| Recalling firm | Civco Medical Instruments Inc |
| Firm location | Kalona, IA |
| Affected scope | 52 kits |
| Distribution | Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2558-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Civco Medical Instruments Inc. Units affected: 52 kits.
Why was this product recalled? ▼
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 3, 2014. Severity: Moderate. Recall number: Z-2558-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2558-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 3, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.