CLASS II Device recall · Reported 8 Jun 2016 · FDA Enforcement Report

Curity Gauze Sponges, 16 ply 4" x 4" x, Sterile 10's in Soft recalled

Covidien is recalling Curity Gauze Sponges, 16 ply 4" x 4" x, Sterile 10's in Soft, distributed nationwide in the US. The recall was initiated on 3 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots beginning with 110000037462 through Lot 120002259962

Quantity recalled713600

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-1847-2016
FDA event ID: 73427
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Terminated
Recall initiated: 3 Mar 2016
FDA classified: 31 May 2016
Reported: 8 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

3 Mar 2016	Recall initiated by company
31 May 2016	Classified by FDA	+89 days
8 Jun 2016	Published in enforcement report	+8 days

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

Reason for recall

Compromised sterility due to breach of barrier

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

Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.

Where it was distributed

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Compromised sterility due to breach of barrier

Which lots are affected?

All lots beginning with 110000037462 through Lot 120002259962

Where was it sold?

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.

Other products in this recall event

12 other products · FDA event 73427

This product is part of a recall event; the main page for the event is Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" x recalled by Covidien.

Reported	Class	Recall	Company	Reason	Where
8 Jun 2016	CLASS II	Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" x recalled by Covidien	Covidien	Sterility	Nationwide
8 Jun 2016	CLASS II	Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack recalled	Covidien	Sterility	Nationwide
8 Jun 2016	CLASS II	Curity All Purpose Sponges, Non-woven, 4 Ply, Soft, 4" x 4" x recalled	Covidien	Sterility	Nationwide
8 Jun 2016	CLASS II	Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" x recalled	Covidien	Sterility	Nationwide
8 Jun 2016	CLASS II	Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" x recalled by Covidien	Covidien	Sterility	Nationwide
8 Jun 2016	CLASS II	Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" x recalled	Covidien	Sterility	Nationwide
8 Jun 2016	CLASS II	Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" x recalled	Covidien	Sterility	Nationwide
8 Jun 2016	CLASS II	Curity" X-Ray Detectable Laparotomy Sponges recalled by Covidien	Covidien	Sterility	Nationwide
8 Jun 2016	CLASS II	Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack recalled	Covidien	Sterility	Nationwide
8 Jun 2016	CLASS II	Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" recalled	Covidien	Sterility	Nationwide
8 Jun 2016	CLASS II	Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" x recalled	Covidien	Sterility	Nationwide
8 Jun 2016	CLASS II	Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack recalled	Covidien	Sterility	Nationwide

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