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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68951

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 01, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Civco Medical Instruments Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2558-2014
Recall number
Z-2558-2014
Initiated
August 01, 2014
Classification
Class II
Status
Terminated
Quantity
52 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging of the recalled product potentially could compromise the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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