BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty… — Class II medical device recall Z-1743-2014
Terminated recall by BioDerm, Inc., reported 2014-06-18, distributed nationwide. On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 E
| Recall number | Z-1743-2014 |
|---|---|
| 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 Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (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 skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.
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-1743-2014. 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.