Teleflex Medical Recalls 12mm Weck Vista Cannula Due to Gas Leakage
Teleflex Medical is recalling 12mm Weck Vista Cannulas because they may leak insufflation gas, potentially delaying laparoscopic 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 the hazard is procedural delay or difficulty rather than direct physical injury or death.
Plain-English summary
Teleflex Medical is recalling 55,521 units of the 12mm Weck Vista Cannula-only. The product code is 405910R, and the affected lot numbers are 01J1200009, 01J1200234, 01J1200380, 01K1200142, 01M1200251, 01A1300140, 01A1300376, 01A1300419, 01A1300370, 01A1300179, 01A1300419, and 01A1300373. These devices are used to provide access, illumination, and observation or manipulation of body cavities, hollow organs, and canals during endoscopic procedures.
The recall was initiated after complaints were received regarding leakage of insufflation gas through the device. This leakage can cause difficulty or delay in the completion of laparoscopic surgical procedures. The agency has classified this as a Class II recall.
The affected units were distributed worldwide, including the United States (nationwide, including Puerto Rico), Australia, Brazil, China, Canada, Malaysia, Korea, Ireland, Singapore, and Vietnam. Users should stop using the affected devices and contact Teleflex Medical for further instructions.
The recalled product
- 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.
- 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 (12)
- Product Code: 405910R
- Lot Numbers: 01J1200009
- 01J1200234
- 01J1200380
- 01K1200142
- 01M1200251
- 01A1300140
- 01A1300376
- 01A1300419
- 01A1300370
- 01A1300179
- 01A1300373.
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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