Reported Jul 15, 2020 · Terminated

COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176

CooperSurgical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350

Is this the product you have?

  • COOPERSURGICAL Os FinderTM Cervical Dilator
  • Taper2.0 mm to 4.0
  • mm OD Length21.5
  • cm Box of 50 Part Number1176
Lot codes and dates
  • Lot 284288 - Expiration date02/24/2023
Amount recalled
2,250 units (45 boxes of 50)

Where it was sold

  • Nationwide

Why it was recalled

Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and the display box indicating the correct Os FinderTM Cervical Dilators, Part Number 1176. The product in the individual product package is the correct Os Finder Cervical Dilator

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 11, 2021 · Data as of Sep 19, 5:31 PM UTC

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