FDA Medical Device Recalls (openFDA)
Teleflex Medical: 5/10 Weck Vista" Universal Balloon Open Access Port Short Length (53mm), 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.
- Recall number
- Z-1288-2014
- Recalling firm
- Teleflex Medical
- Product
- 5/10 Weck Vista" Universal Balloon Open Access Port Short Length (53mm), 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.
- Status
- Terminated
- Initiated
- 2014-03-11
- Posted
- 2014-03-25
- Terminated
- 2017-08-15
- Reason
- Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
- Root cause
- Nonconforming Material/Component
- Action
- Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
- Quantity
- 55,521 ea. in total
- Distribution
- Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
- Lot, serial or model codes
- Product Code: 410944S, Lot Numbers: 01J1200460, 01K1200619, 01L1200515, and 01E1300137.
- 510(k) numbers
- ["K112456"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28