Severity
Moderate
FDA Devices recall · Reported August 21, 2013
Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
Atrium Medical Corporation recalled C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies. - a moderate-severity action.
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies. was recalled by Atrium Medical Corporation in August 21, 2013. Reason: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner…. Check the official notice for the remedy. Verify recall #Z-1937-2013 with the FDA Devices before acting.
The recall
Atrium Medical Corporation issued this moderate-severity FDA Devices recall-Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1937-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1937-2013) was formally reported on August 21, 2013, with the manufacturer initiating the action on July 19, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Atrium Medical Corporation is listed as the recalling firm, operating out of Hudson, NH. Federal records list the affected scope as 1501 units.
The documented reason for this recall is: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions Distribution data in the federal record shows the product reached: USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ire…. 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
1501 units
Related Recalls
6
3 from same agency
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1937-2013 |
| Date reported | August 21, 2013 |
| Date initiated | July 19, 2013 |
| Recalling firm | Atrium Medical Corporation |
| Firm location | Hudson, NH |
| Affected scope | 1501 units |
| Distribution | USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Ja… |
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 August 21, 2013. 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.