BioDerm Safe n' Dry 21006 — Class II medical device recall Z-1744-2014
Terminated recall by BioDerm, Inc., reported 2014-06-18, distributed nationwide. On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in th
| Recall number | Z-1744-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioDerm, Inc., Largo, FL, United States |
| Recall initiated | 2011-05-31 |
| Classified | 2014-06-10 |
| Reported by FDA | 2014-06-18 |
| Terminated | 2014-06-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, NL |
| Quantity | 26,040 units |
| Reason classes | microbial contamination |
| Model numbers | 21006, 21026, 21036, 21046, 23036, 23046 |
Product
BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
Reason for recall
On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. Potential bacterial contamination of Smith and Nephew skin wipes by one of their contract manufacturers.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1744-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.