27023WU Balloon Catheter — Class II medical device recall Z-1728-2013
Terminated recall by Karl Storz Endoscopy America Inc, reported 2013-07-24, distributed in AZ, FL, IL, IN, TX. Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging ma
| Recall number | Z-1728-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Karl Storz Endoscopy America Inc, Southbridge, MA, United States |
| Recall initiated | 2013-05-31 |
| Classified | 2013-07-12 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2013-07-15 |
| Distributed | AZ, FL, IL, IN, TX |
| Quantity | 40 units |
| Reason classes | sterility |
| Lot numbers | 08451, 09071, 09091, 09161, 09201, 09251, 09431, 09471, 11401, 11501, 12051, 12101, 12171, 12271, 12281, 12471 |
Product
27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.
Reason for recall
Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.
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-1728-2013. 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.