Severity
Moderate
FDA Devices recall · Reported July 29, 2015
Devon Light Gloves contain splits or holes compromising the sterility
Covidien LLC recalled NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711 - a moderate-severity action.
NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711 was recalled by Covidien LLC in July 29, 2015. Reason: Devon Light Gloves contain splits or holes compromising the sterility. Check the official notice for the remedy. Verify recall #Z-2117-2015 with the FDA Devices before acting.
The recall
Covidien LLC issued this moderate-severity FDA Devices recall-Devon Light Gloves contain splits or holes compromising the sterility.
Sourced from official FDA Devices enforcement records. Verify recall #Z-2117-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2117-2015) 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 list the affected scope as N/A.
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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
N/A
Related Recalls
6
3 from same agency
NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711
Devon Light Gloves contain splits or holes compromising the sterility
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2117-2015 |
| Date reported | July 29, 2015 |
| Date initiated | April 16, 2015 |
| Recalling firm | Covidien LLC |
| Firm location | North Haven, CT |
| Affected scope | N/A |
| 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.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 29, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.