The Recall Desk
HighFDA (Devices)·Z-2118-2015·Announced 2015-07-29

FDA Recalls Non-Sterile Subassemblies Due to Sterility Compromise

FDA is recalling specific non-sterile subassemblies from Covidien LLC because they contain splits or holes that compromise sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling specific non-sterile subassemblies manufactured by Covidien LLC. The recall involves catalog numbers SA1008, SA1578, SA2000, SA2001, SA2002, SA2004, SA2005, SA2006, SA2007, SA2008, SA2032B, SA2038A, SA2042, SA2049, SA2058B, SA2074, SA2075, SA2109, SA2119, SA2120, SA2121, SA2122, SA2164A, SA2172A, SA2172B, SA2173C, SA2174B, SA2185, SA2198D, SA2199, SA2219, SA3011, SA3013, SA3018, SA3040, SA3045, SA3060, SA3062A, SA3068, SA3069, SA3071, SA3076, SA3076A, SA3077, SA3078, SA3080, SA4003, SA4003A, SA4013, SA4014, SA4015, SA5006, SA5015, SA5017, and SA2140. The affected units are identified by lot numbers beginning with 508xxxx or lower.

The recall was initiated because the Devon Light Gloves contained in these subassemblies have splits or holes that compromise sterility. This defect poses a risk of contamination. The affected products were distributed worldwide, including the United States (nationwide), the Virgin Islands, 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 the UAE.

Healthcare facilities and distributors should stop using the affected subassemblies and contact the recalling firm for instructions on return or replacement. Consumers should not use these products if they have them in their possession.

The recalled product

Product
Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY SA
Manufacturer
Covidien LLC
Category
Medical Device — Surgical Gloves
Hazard
Affected units
385,486

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot number begins 508xxxx or lower

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 14 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Related recalls

Same manufacturer · Covidien LLC

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Same hazard · sterility compromise

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