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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Teleflex Medical: Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

Agency Publication Date: March 25, 2014
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Affected Products

Product: Weck¿ Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, 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.

Product Code: 405910, Lot Number: 01G1200242, 01G1200341, 01J1200100, 01J1200378, 01J1200461, 01K1200266, 01K1200171, 01L1200182, 01A1300139, 01B1300050, 01D1300318, 01E1300217, and 01E1300432.

Lot Numbers:
405910
Number
Product: 10mm Weck¿ Vista" Cannula-only, Teleflex Medical, 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.

Product Code: 405912, Lot Number: 01J1200462, 01K1200129, 01K1200377, 01K1200596, 01K1200611, 01L1200369, 01A1300106, 01E1300218, 01E1300311, 01F1300135, and 01F1300079.

Lot Numbers:
405912
Number
Product: 5/10 mm Weck¿, Vista" Optical Bladeless Laparoscopic Access Port, 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.

Product Code: 405933, Lot Numbers: 01L1200353, and 01F1300080.

Lot Numbers:
405933
Numbers
Product: 5/10 mm Weck¿, Vista" Universal Cannula, Teleflex Medical, 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.

Product Code: 410944, Lot Numbers: 01K1200601, 01K1200623, 01L1200355, 01L1200378, 01A1300203, 01D1300412, 01J1200241, 01K1200066, 01K1200622

Lot Numbers:
410944
Numbers
Product: Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, 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.

Product Code: 40591213, Lot Numbers: 01J1200416, 01K1200612, 01L1200160, 01A1300418, 01A1300427, 01E1300056, 01E1300052, 01E1300055

Lot Numbers:
40591213
Numbers
Product: Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, 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.

Product Code: 405910C, Lot Numbers: 01G1200243, 01J1200226, 01L1200368, 01A1300177, 01D1300107, 01E1300140, 01E1300435.

Lot Numbers:
405910C
Numbers
Product: 12mm Weck¿ Vista" Cannula-only, Teleflex Medical, 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.

Product Code: 405910R, Lot Numbers: 01J1200009, 01J1200234, 01J1200380, 01K1200142, 01M1200251, 01A1300140, 01A1300376, 01A1300419, 01A1300370, 01A1300179, 01A1300419, 01A1300373.

Lot Numbers:
405910R
Numbers
Product: 5/10/12 mm Weck¿ Vista" Optical Bladeless Laparoscopic Access Port, 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.

Product Code: 405910RC, Lot Numbers: 01J1200010, 01J1200242, 01K1200070, 01A1300141, 01B1300052, and 01D1300319.

Lot Numbers:
405910RC
Numbers
Product: 5/10/12 mm Weck¿ Vista" Universal Cannula, 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.

Product Code: 405912C, Lot Numbers: 01J1200384, 01K1200725, 01L1200352, and 01B1300009.

Lot Numbers:
405912C
Numbers
Product: 5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, 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.

Product Code: 405912R, Lot Numbers: 01H1200064, 01K1200378, 01K1200621, 01L1200370, 01M1200071, 01M1200252, 01A1300170, 01A1300201, 01A1300420, 01A1300545, and 01F1300136.

Lot Numbers:
405912R
Numbers
Product: 5/10 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.

Product Code: 405912RC, Lot Numbers: 01G1200244, 01M1200020, 01M1200068, 01A1300546, and 01A1300559.

Lot Numbers:
405912RC
Numbers
Product: 5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), 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.

Product Code: 410944L, Lot Numbers: 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, and 01A1300202.

Lot Numbers:
410944L
Numbers
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.

Product Code: 410944S, Lot Numbers: 01J1200460, 01K1200619, 01L1200515, and 01E1300137.

Lot Numbers:
410944S
Numbers
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.

Product Code: 410944S, Lot Numbers: 01J1200460, 01K1200619, 01L1200515, and 01E1300137.

Lot Numbers:
410944S
Numbers
Product: 5/10/12 Weck¿ Vista" Universal Balloon Open Access Port  Long Length (100mm), 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.

Product Code: 412944L, Lot Numbers: 01J1200231, 01K1200597, 01K1200618, 01K1200728, 01A1300178, 01D1300316, 01E1300310, and 01E1300436.

Lot Numbers:
412944L
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 67710
Status: Resolved
Manufacturer: Teleflex Medical
Manufactured In: United States
Units Affected: 15 products (55,521 ea. in total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.