SteriGear Urinary Drain Bag with Fig Leaf Cover — Class II medical device recall Z-1848-2014
Terminated recall by SteriGear, LLC, reported 2014-07-02, distributed nationwide. SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating
| Recall number | Z-1848-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SteriGear, LLC, Provo, UT, United States |
| Recall initiated | 2011-01-11 |
| Classified | 2014-06-23 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2015-01-02 |
| Distributed | Nationwide (US) |
| Quantity | 110,560 |
| UPC / GTIN / UDI-DI | 00851616002007 |
| Model numbers | 10270 |
Product
SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter
Reason for recall
SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.
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-1848-2014. 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.