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

Delivery/C-Section, Sterile-Kits containing the Devon Light Glove recalled

Covidien is recalling Delivery/C-Section, 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 recalled8,630 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-2107-2015
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

Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY 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

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 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

13 other products · FDA event 71113

This product is part of a recall event; the main page for the event is ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove recalled.

Reported	Class	Recall	Company	Reason	Where
29 Jul 2015	CLASS II	ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove recalled	Covidien	Sterility	Nationwide
29 Jul 2015	CLASS II	Single Basin Kits, Sterile-.Kits containing the Devon Light Glove recalled	Covidien	Sterility	Nationwide
29 Jul 2015	CLASS II	Devon Light Gloves, Sterile-Single Units A disposable recalled	Covidien	Sterility	Nationwide
29 Jul 2015	CLASS II	Non Sterile Subassembly recalled by Covidien	Covidien	Sterility	Nationwide
29 Jul 2015	CLASS II	Double Basin Kit ,Sterile-Kits containing the Devon Light Glove recalled	Covidien	Sterility	Nationwide
29 Jul 2015	CLASS II	Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove recalled	Covidien	Sterility	Nationwide
29 Jul 2015	CLASS II	Augmentation Kit , Sterile-.Kits containing the Devon Light Glove recalled	Covidien	Sterility	Nationwide
29 Jul 2015	CLASS II	Major Kit, Sterile-.Kits containing the Devon Light Glove recalled	Covidien	Sterility	Nationwide
29 Jul 2015	CLASS II	Hysto Pack, Non-sterile recalled by Covidien	Covidien	Sterility	Nationwide
29 Jul 2015	CLASS II	Mini-Kits, Sterile-Kits containing the Devon Light Glove recalled	Covidien	Sterility	Nationwide
29 Jul 2015	CLASS II	Surgical Kit Sterile-Kits containing the Devon Light Glove recalled	Covidien	Sterility	Nationwide
29 Jul 2015	CLASS II	Ns-3600-B Lite Glove -Bulk, Non-sterile recalled by Covidien	Covidien	Sterility	Nationwide
29 Jul 2015	CLASS II	Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove recalled	Covidien	Sterility	Nationwide

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All 447

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29 Jul 2026Device	CLASS II	P28 Phanton Intramedullary Nail System recalled by Paragon 28	Paragon 28	Sterility	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
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8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
3 Jun 2026Device	CLASS II	Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled	O&M Halyard	Other	Nationwide