Rusch — Class II medical device recall Z-2661-2014
Terminated recall by Teleflex Medical, reported 2014-09-24, distributed nationwide. Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Ru
| Recall number | Z-2661-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2014-09-04 |
| Classified | 2014-09-18 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2017-02-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BH, CA, CH, DE, DK, ES, FI, GB, HR, HU, IE, IT, NL, NO, PT, RO, RU, SA, SK, TR |
| Reason classes | labeling |
| Lot numbers | 13261, 13291, 13301, 13311, 13351, 13371, 13391, 13411, 13441, 13451, 13461, 13481, 13491, 13501, 13511, 14027, 14041, 14091, 14101, 14131, 14281 |
Product
Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
Reason for recall
Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.
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-2661-2014. 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.