Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O… — Class III medical device recall Z-0797-2020
Terminated recall by Teleflex Medical, reported 2020-01-22, distributed in FL, GA, IL, MA, ME, MO, NC, NJ…. The device label incorrectly states that the device is sterile. This product is an externally applied male con
| Recall number | Z-0797-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Morrisville, NC, United States |
| Recall initiated | 2019-02-27 |
| Classified | 2020-01-10 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2023-09-06 |
| Distributed | FL, GA, IL, MA, ME, MO, NC, NJ, OH, TX, WA |
| Countries outside the US | CA |
| Quantity | 13,104 devices |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 24026704549843 |
| Lot numbers | 74A1800577, 74A1801939, 74B1800363, 74B1801604, 74B1802746, 74C1801178, 74C1801294, 74C1802132, 74G1800047, 74G1800891, 74G1801166, 74G1802121, 74H1700894, 74J1700864, 74J1702489, 74K1702257, 74L1700074, 74L1701701, 74M1700121, 74M1701150, 74M1701769 |
| Model numbers | A1500M |
Product
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Reason for recall
The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.
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-0797-2020. 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.