Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported November 5, 2014
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasio
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Coloplast Manufacturing US, LLC recalled Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Orig… - a low-severity action.
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Orig… was recalled by Coloplast Manufacturing US, LLC in November 5, 2014. Reason: Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing whic…. Check the official notice for the remedy. Verify recall #Z-0138-2015 with the FDA Devices before acting.
The recall
Coloplast Manufacturing US, LLC issued this low-severity FDA Devices recall-Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing whic….
- Low
- severity level
- 6 units
- affected scope
- Class III
- classification
- November 5, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0138-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0138-2015) was formally reported on November 5, 2014, with the manufacturer initiating the action on September 8, 2014. It is classified under Low severity (Class III), 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 6.
The documented reason for this recall is: Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled. Distribution data in the federal record shows the product reached: US Distribution to MO and RI.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6
Related Recalls
6
3 from same agency
Product description
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.
Reason for recall
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0138-2015 |
| Date reported | November 5, 2014 |
| Date initiated | September 8, 2014 |
| Recalling firm | Coloplast Manufacturing US, LLC |
| Firm location | Minneapolis, MN |
| Affected scope | 6 |
| Distribution | US Distribution to MO and RI. |
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-0138-2015) 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? ▼
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.. Recalled by Coloplast Manufacturing US, LLC. Units affected: 6.
Why was this product recalled? ▼
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2014. Severity: Low. Recall number: Z-0138-2015.
Where was the recalled product distributed? ▼
Distribution: US Distribution to MO and RI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0138-2015) 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 5, 2014. 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.