Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports
Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports due to reported gas leakage that may delay surgical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (surgical delay) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.
Plain-English summary
Teleflex Medical is recalling 55,521 units of the Weck Vista Universal Laparoscopic Port, available in 5mm, 10mm, and 12mm sizes. The affected product code is 405910C, and the recall includes specific lot numbers: 01G1200243, 01J1200226, 01L1200368, 01A1300177, 01D1300107, 01E1300140, and 01E1300435.
The recall was initiated after complaints were received regarding the leakage of insufflation gas through the device. This defect can cause difficulty or delay in the completion of laparoscopic surgical procedures. The FDA has classified this as a Class II recall.
The affected devices were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in Australia, Brazil, China, Canada, Malaysia, Korea, Ireland, Singapore, and Vietnam. Healthcare facilities should stop using the affected lots and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Teleflex Medical
- Affected units
- 55,521
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Product Code: 405910C
- Lot Numbers: 01G1200243
- 01J1200226
- 01L1200368
- 01A1300177
- 01D1300107
- 01E1300140
- 01E1300435.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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