Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 16, 2016
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Covidien LLC recalled Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: … - a moderate-severity action.
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: … was recalled by Covidien LLC in November 16, 2016. Reason: Added Instructions for Use: After application, inspect the Light Glove for barrier integrity. Check the official notice for the remedy. Verify recall #Z-0365-2017 with the FDA Devices before acting.
The recall
Covidien LLC issued this moderate-severity FDA Devices recall-Added Instructions for Use: After application, inspect the Light Glove for barrier integrity.
- Moderate
- severity level
- 119K units
- affected scope
- Class II
- classification
- November 16, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0365-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0365-2017) was formally reported on November 16, 2016, with the manufacturer initiating the action on September 29, 2016. 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 118,800, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Added Instructions for Use: After application, inspect the Light Glove for barrier integrity Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway P…. 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.
Medical Devices recalls over time
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.
Affected scope
118,800
Related Recalls
6
3 from same agency
Product description
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Reason for recall
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0365-2017 |
| Date reported | November 16, 2016 |
| Date initiated | September 29, 2016 |
| Recalling firm | Covidien LLC |
| Firm location | North Haven, CT |
| Affected scope | 118,800 |
| Distribution | Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Rus… |
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.
- Check the recall number (Z-0365-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles. Recalled by Covidien LLC. Units affected: 118,800.
Why was this product recalled? ▼
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 16, 2016. Severity: Moderate. Recall number: Z-0365-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United Arab Emirates United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0365-2017) 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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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 November 16, 2016. 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.