Severity
Moderate
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 SA2006 NON STERILE SUBASSEMBLY SA2007 NON STERILE SUBASSEMBLY SA2008 SA-7457-R NS SUBASSEMBLY SA2032B NSSA SA2038A NSSA SA2042 SA2042 SUBASSEMBLY NS SA2049 SA2049 NON STERILE SUBASSEMBLY SA2058B NSSA SA2074 SA2074
Reported: July 29, 2015 Initiated: April 16, 2015 #Z-2118-2015 385486 units
Covidien LLC issued this FDA Devices recall on July 29, 2015. Classified as Moderate severity (Class II). Approximately 385486 units are affected. The recall was issued because: Devon Light Gloves contain splits or holes compromising the sterility. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-2118-2015) was formally reported on July 29, 2015, with the manufacturer initiating the action on April 16, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Covidien LLC is listed as the recalling firm, operating out of North Haven, CT. Federal records indicate 385486 units are affected, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Devon Light Gloves contain splits or holes compromising the sterility Distribution data in the federal record shows the product reached: 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, Nethe…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
385486
Related Recalls
6
6 from same agency
Recall Progress (industry avg ~60%) 60.0%
Product Description
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 SA2006 NON STERILE SUBASSEMBLY SA2007 NON STERILE SUBASSEMBLY SA2008 SA-7457-R NS SUBASSEMBLY SA2032B NSSA SA2038A NSSA SA2042 SA2042 SUBASSEMBLY NS SA2049 SA2049 NON STERILE SUBASSEMBLY SA2058B NSSA SA2074 SA2074 NON STERILE SUBASSEMBLY SA2075 SA2075 NON STERILE SUBASSEMBLY SA2109 SA2109 NON STERILE SUBASSY SA2119 SA2119 NON STERILE SUBASSY SA2120 SA2120 NON STERILE SUBASSY SA2121 NON STERILE SUBASSY SA2122 SA2122 NON STERILE SUBASSY SA2164A NSSA SA2172A NSSA SA2172B NSSA SA2173C NSSA SA2174B NSSA SA2185 SRM800 NSSA SA2198D NSSA SA2199 SA2199 NON STERILE SUBASSY SA2219 NSSA SA3011 SA3011 NON STERILE SUBASSY SA3013 SA3013 NON STERILE SUBASSY SA3018 SA3018 NON STERILE SUBASSY SA3040 SA3040 NON STERILE SUBASSY SA3045 NSSA SA3060 SA3060 NON STERILE SUBASSY SA3062A NSSA SUBASSEMBLY SA3068 SA3068 NON STERILE SUBASSY SA3069 SA3069 NON STERILE SUBASSY SA3071 SA3071 NON STERILE SUBASSY SA3076 NSSA SA3076A NSSA SA3077 NSSA BUTTON SA3078 NSSA ROCKER SA3080 NSSA SA4003 NON STERILE SUBASSEMBLY SA4003A NON STERILE SUBASSEMBLY SA4013 NSSA SA4014 NSSA SA4015 NSSA SA5006 NSSA SA5015 NSSA SA5017 NON STERILE SUBASSEMBLY SA2140 SA2140 NON STERILE SUBASSY
Reason for Recall
Devon Light Gloves contain splits or holes compromising the sterility
Details
- Recalling Firm
- Covidien LLC
- Units Affected
- 385486
- Distribution
- 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.
- Location
- North Haven, CT
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2118-2015 |
| Date reported | July 29, 2015 |
| Date initiated | April 16, 2015 |
| Recalling firm | Covidien LLC |
| Units affected | 385486 |
| Distribution | 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, Irel… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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 SA2006 NON STERILE SUBASSEMBLY SA2007 NON STERILE SUBASSEMBLY SA2008 SA-7457-R NS SUBASSEMBLY SA2032B NSSA SA2038A NSSA SA2042 SA2042 SUBASSEMBLY NS SA2049 SA2049 NON STERILE SUBASSEMBLY SA2058B NSSA SA2074 SA2074 NON STERILE SUBASSEMBLY SA2075 SA2075 NON STERILE SUBASSEMBLY SA2109 SA2109 NON STERILE SUBASSY SA2119 SA2119 NON STERILE SUBASSY SA2120 SA2120 NON STERILE SUBASSY SA2121 NON STERILE SUBASSY SA2122 SA2122 NON STERILE SUBASSY SA2164A NSSA SA2172A NSSA SA2172B NSSA SA2173C NSSA SA2174B NSSA SA2185 SRM800 NSSA SA2198D NSSA SA2199 SA2199 NON STERILE SUBASSY SA2219 NSSA SA3011 SA3011 NON STERILE SUBASSY SA3013 SA3013 NON STERILE SUBASSY SA3018 SA3018 NON STERILE SUBASSY SA3040 SA3040 NON STERILE SUBASSY SA3045 NSSA SA3060 SA3060 NON STERILE SUBASSY SA3062A NSSA SUBASSEMBLY SA3068 SA3068 NON STERILE SUBASSY SA3069 SA3069 NON STERILE SUBASSY SA3071 SA3071 NON STERILE SUBASSY SA3076 NSSA SA3076A NSSA SA3077 NSSA BUTTON SA3078 NSSA ROCKER SA3080 NSSA SA4003 NON STERILE SUBASSEMBLY SA4003A NON STERILE SUBASSEMBLY SA4013 NSSA SA4014 NSSA SA4015 NSSA SA5006 NSSA SA5015 NSSA SA5017 NON STERILE SUBASSEMBLY SA2140 SA2140 NON STERILE SUBASSY. Recalled by Covidien LLC. Units affected: 385486.
Why was this product recalled? ▼
Devon Light Gloves contain splits or holes compromising the sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2015. Severity: Moderate. Recall number: Z-2118-2015.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2118-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).