Severity
Moderate
ModerateClass IITerminated
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-1486-2013) was formally reported on June 12, 2013, with the manufacturer initiating the action on May 13, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Coloplast Manufacturing US, LLC is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 772 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Distribution to: KY, MI, OH, PR, TX, and VA.. 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
772 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Coloplast Manufacturing US, LLC. Units affected: 772 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2013. Severity: Moderate. Recall number: Z-1486-2013.
Where was the recalled product distributed? ▼
Distribution: US Distribution to: KY, MI, OH, PR, TX, and VA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1486-2013) 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 June 12, 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.