HSG Trays/HS 5F Catheter Combo — Class II medical device recall Z-1481-2015
Terminated recall by Catheter Research, Inc, reported 2015-04-29, distributed in CA, FL, IL, MA, MN, OH, VA, WI. HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the sh
| Recall number | Z-1481-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Catheter Research, Inc, Indianapolis, IN, United States |
| Recall initiated | 2015-04-07 |
| Classified | 2015-04-21 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2015-07-17 |
| Distributed | CA, FL, IL, MA, MN, OH, VA, WI |
| Quantity | 880 units |
| Reason classes | labeling |
| Lot numbers | J436, J436A, J436B, J436C, J436D, J437A, J437B, J437C, J437D |
Product
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
Reason for recall
HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.
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-1481-2015. 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.