Severity
Moderate
FDA Devices recall · Reported April 12, 2017
Product sterility is compromised due to breach of sterile barrier
Covidien LLC recalled Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists… - a moderate-severity action.
Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists… was recalled by Covidien LLC in April 12, 2017. Reason: Product sterility is compromised due to breach of sterile barrier. Check the official notice for the remedy. Verify recall #Z-1739-2017 with the FDA Devices before acting.
The recall
Covidien LLC issued this moderate-severity FDA Devices recall-Product sterility is compromised due to breach of sterile barrier.
Sourced from official FDA Devices enforcement records. Verify recall #Z-1739-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1739-2017) was formally reported on April 12, 2017, with the manufacturer initiating the action on March 3, 2017. 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 7168000, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: Product sterility is compromised due to breach of sterile barrier Distribution data in the federal record shows the product reached: Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland…. 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
7168000
Related Recalls
6
3 from same agency
Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection
Product sterility is compromised due to breach of sterile barrier
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1739-2017 |
| Date reported | April 12, 2017 |
| Date initiated | March 3, 2017 |
| Recalling firm | Covidien LLC |
| Firm location | North Haven, CT |
| Affected scope | 7168000 |
| Distribution | Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland, Israel, Italy, Ken… |
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 April 12, 2017. 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.