CLASS III Device recall · Reported 5 Nov 2014 · FDA Enforcement Report
Biatain Super Non-Adhesive recalled by Coloplast Manufacturing US
Coloplast Manufacturing US is recalling Biatain Super Non-Adhesive, distributed in Missouri, Rhode Island. The recall was initiated on 8 Sep 2014 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0138-2015
- FDA event ID
- 69279
- Recalling firm
- Coloplast Manufacturing US, Minneapolis, MN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Sep 2014
- FDA classified
- 24 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 8 Sep 2014 | Recall initiated by company | |
| 24 Oct 2014 | Classified by FDA | +46 days |
| 5 Nov 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to MO and RI.
Questions about this recall
Is Biatain Super Non-Adhesive recalled?
Yes. Coloplast Manufacturing US recalled Biatain Super Non-Adhesive on 8 Sep 2014. The recall is Class III and its status is Terminated. Recall number Z-0138-2015.
Why was it recalled?
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Which lots are affected?
4201931
Where was it sold?
US Distribution to MO and RI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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