CLASS II Device recall · Reported 18 Jun 2014 · FDA Enforcement Report

Cooper Surgical Tampa Catheter Intended for Hysterosonography recalled

CooperSurgical is recalling Cooper Surgical Tampa Catheter Intended for Hysterosonography, distributed nationwide in the US. The recall was initiated on 13 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 141525

Quantity recalled1180 units

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-1782-2014
FDA event ID: 68317
Recalling firm: CooperSurgical, Trumbull, CT
Classification: Class II
Status: Terminated
Recall initiated: 13 May 2014
FDA classified: 11 Jun 2014
Reported: 18 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

13 May 2014	Recall initiated by company
11 Jun 2014	Classified by FDA	+29 days
18 Jun 2014	Published in enforcement report	+7 days

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

Reason for recall

Sterility of the device may be compromised due to unsealed pouch

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

Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005

Where it was distributed

Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.

Nationwide Alabama California Colorado Connecticut Florida Massachusetts Missouri North Carolina New Jersey New York Ohio Pennsylvania Virginia Vermont

Questions about this recall

Why was it recalled?

Sterility of the device may be compromised due to unsealed pouch

Which lots are affected?

Lot 141525

Where was it sold?

Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.

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.

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