CLASS II Device recall · Reported 3 Sep 2014 · FDA Enforcement Report

CollectEVAC, Sterile device with tubing and adaptor recalled

Civco Medical Instruments is recalling CollectEVAC, Sterile device with tubing and adaptor for use with Acmi and Storz/Wolf, distributed in 16 states. The recall was initiated on 1 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers: M431760, M431710, M426580, M430200, M423010

Quantity recalled52 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2558-2014
FDA event ID: 68951
Recalling firm: Civco Medical Instruments, Kalona, IA
Classification: Class II
Status: Terminated
Recall initiated: 1 Aug 2014
FDA classified: 28 Aug 2014
Reported: 3 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Other Medical Devices

Timeline

1 Aug 2014	Recall initiated by company
28 Aug 2014	Classified by FDA	+27 days
3 Sep 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.

Arizona Illinois Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina New Jersey New York South Dakota Tennessee Virginia Wisconsin

Questions about this recall

Why was it recalled?

A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.

Which lots are affected?

Lot numbers: M431760, M431710, M426580, M430200, M423010

Where was it sold?

Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Civco Medical Instruments

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8 Apr 2026Device	CLASS II	eTRAX Needle System Starter Kit (for Aurora Trackers) recalled	Civco Medical Instruments	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle Sensor -(for Aurora Trackers) recalled	Civco Medical Instruments	Processing Deviation	OH, PA, WA

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