FDA Medical Device Recalls (openFDA)
Teleflex Medical: Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. 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-1323-2014
- Recalling firm
- Teleflex Medical
- Product
- Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. 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
- 2014-04-02
- Terminated
- 2016-01-28
- Reason
- Complaints of leakage of insufflation gas through the device.
- Root cause
- Nonconforming Material/Component
- Action
- Letters were issued on March 11, 2014 to customers informing them of the recall. The letter asked the consignee to immediately discontinue use and quarantine any products on hand. The letter included a Recall Acknowledgement Form which is to be returned. A letter was also issued to distributors on March 11, 2014, requesting them to conduct a sub-recall.
- Quantity
- 55,521 total
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.
- Lot, serial or model codes
- Lots Catalog No. 405910 - 01G1200242, 01G1200242, 01G1200341, 01J1200100, 01J1200100, 01J1200378, 01J1200461, 01K1200266, 01K1200171, 01K1200266, 01L1200182, 01A1300139, 01A1300139, 01B1300050, 01D1300318, 01E1300139, 01E1300217, 01E1300432; Catalog No. 405912 01J1200462, 01K1200129, 01K1200377, 01K1200596, 01K1200611, 01K1200611, 01L1200369, 01L1200369, 01L1200369, 01A1300106, 01A1300106, 01A1300106, 01E1300218, 01E1300311, 01F1300135, 01F1300079; Catalog No. 40591213- 01J1200416, 01K1200612, 01L1200160, 01A1300418, 01A1300427, 01E1300056, 01E1300052, 01E1300055
- 510(k) numbers
- ["K082156"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3005747797
- Firm city
- Durham
- 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