Infinity¿ sampling device — Class II medical device recall Z-2396-2012
Terminated recall by US Endoscopy Group Inc, reported 2012-09-26, distributed in CA, FL, GA, IA, IL, MA, ME, MN…. US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the cathe
| Recall number | Z-2396-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | US Endoscopy Group Inc, Mentor, OH, United States |
| Recall initiated | 2011-12-22 |
| Classified | 2012-09-17 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2013-03-22 |
| Distributed | CA, FL, GA, IA, IL, MA, ME, MN, MO, NC, NH, OH, OK, PA, TN, TX, VA, WA, WV |
| Countries outside the US | AU, CA, DE, FI, GB, IL, IN, IT, NL, NZ |
| Quantity | 393 devices |
| Lot numbers | 49680, 50793, 50794, 50795, 52577, 53023 |
Product
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
Reason for recall
US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
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-2396-2012. 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.