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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81037

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

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Event summary

Timeline bucket
September 04, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
CooperSurgical, 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

Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

Z-3278-2018
Recall number
Z-3278-2018
Initiated
September 04, 2018
Classification
Class II
Status
Terminated
Recalling firm
CooperSurgical, Inc.
Quantity
18,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

Code information

Lots 244660, 245964, 250426, 251395 , 244667, 244883, 244884, 245603, 245973, 246138, & 248871

Distribution pattern

Worldwide Distribution n- US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WV, and the following foreign countries of: Australia, Canada, Colombia, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, Russian Federation, Saudi Arabia, Singapore, Spain, Switzerland, Turkey, and the United Kingdom.

Field note

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