FDA Devices recall · Reported June 12, 2013
Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.
Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date.
Coloplast Manufacturing US, LLC recalled Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52… - a moderate-severity action.
Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52… was recalled by Coloplast Manufacturing US, LLC in June 12, 2013. Reason: Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because i…. Check the official notice for the remedy. Verify recall #Z-1486-2013 with the FDA Devices before acting.
The recall
Coloplast Manufacturing US, LLC issued this moderate-severity FDA Devices recall-Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because i….
- Moderate
- severity level
- 772 units
- affected scope
- Class II
- classification
- June 12, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1486-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.
Reason for recall
Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1486-2013 |
| Date reported | June 12, 2013 |
| Date initiated | May 13, 2013 |
| Recalling firm | Coloplast Manufacturing US, LLC |
| Firm location | Minneapolis, MN |
| Affected scope | 772 units |
| Distribution | US Distribution to: KY, MI, OH, PR, TX, and VA. |
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-1486-2013) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026