Teleflex Recalls Weck Vista Optical Bladeless Laparoscopic Access Ports
Teleflex Medical is recalling 55,521 Weck Vista Optical Bladeless Laparoscopic Access 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 where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Teleflex Medical is recalling 55,521 units of the 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port. The recall affects product code 405933 and lot numbers 01L1200353 and 01F1300080. These devices are used to provide access, illumination, and observation of body cavities during laparoscopic surgeries.
The recall was initiated after complaints were received regarding the leakage of insufflation gas through the device. This leakage can cause difficulty or delay in the completion of laparoscopic surgical procedures.
The affected products 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 and consumers should stop using the affected devices and contact Teleflex Medical for further instructions.
The recalled product
- 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.
- 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 (3)
- Product Code: 405933
- Lot Numbers: 01L1200353
- and 01F1300080.
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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