5/10/12 Weck¿ Vista" Universal Balloon Open Access Port Standard… — Class II medical device recall Z-1289-2014
Terminated recall by Teleflex Medical, reported 2014-04-02, distributed nationwide. Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or dela
| Recall number | Z-1289-2014 |
|---|---|
| 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 | 2014-03-11 |
| Classified | 2014-03-25 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2017-08-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CN, IE, KR, MY, SG, VN |
| Quantity | 55,521 units |
| Reason classes | packaging |
| Lot numbers | 01E1300137, 01J1200460, 01K1200619, 01L1200515 |
Product
5/10/12 Weck¿ Vista" Universal Balloon Open Access Port Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Reason for recall
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
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-1289-2014. 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.