CLASS II Device recall · Reported 29 Jul 2015 · FDA Enforcement Report

Augmentation Kit , Sterile-.Kits containing the Devon Light Glove recalled

Covidien is recalling Augmentation Kit , Sterile-.Kits containing the Devon Light Glove, distributed nationwide in the US. The recall was initiated on 16 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number begins 508xxxx or lower

Quantity recalled144 kits

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-2116-2015
FDA event ID: 71113
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Terminated
Recall initiated: 16 Apr 2015
FDA classified: 20 Jul 2015
Reported: 29 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Masks, Gloves & PPE

Timeline

16 Apr 2015	Recall initiated by company
20 Jul 2015	Classified by FDA	+95 days
29 Jul 2015	Published in enforcement report	+9 days

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

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

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

Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit

Where it was distributed

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

Nationwide

Questions about this recall

Is Augmentation Kit , Sterile-.Kits containing the Devon Light Glove recalled?

Yes. Covidien recalled Augmentation Kit , Sterile-.Kits containing the Devon Light Glove on 16 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-2116-2015.

Why was it recalled?

Devon Light Gloves contain splits or holes compromising the sterility

Which lots are affected?

Lot number begins 508xxxx or lower

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 21 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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