Teleflex Recalls Weck Vista Optical Bladeless Laparoscopic Access Ports
Teleflex Medical is recalling 55,521 Weck Vista Optical Bladeless Laparoscopic Access Ports due to complaints of insufflation gas leakage.
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. The hazard involves a functional defect (gas leakage) in a medical device used during surgery, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Teleflex Medical is recalling 55,521 units of the 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port (Catalog No. 405910R) and the 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port (Catalog No. 405912R). These devices are used to provide access, illumination, and observation or manipulation of body cavities, hollow organs, and canals.
The recall was initiated due to complaints of leakage of insufflation gas through the device. The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.
Healthcare providers and facilities should stop using the affected devices and contact Teleflex Medical for further instructions. Specific lot numbers are listed in the official recall documentation.
The recalled product
- Product
- 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R. An endoscope and accessories is a device used to provide access, illumination, and allow observation or ma
- Manufacturer
- Teleflex Medical
- Hazard
- 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 (20)
- Lots - Catalog No. 40591OR - 01J1200009
- 01J1200234
- 01J1200380
- 01K1200142
- 01M1200251
- 01A1300140
- 01A1300376
- 01A1300419
- 01A1300370
- 01A1300179
- 01A1300373
- Catalog No. 405912R - 01H1200064
- 01K1200379
- 01K1200621
- 01L1200370
- 01M1200071
- 01M1200252
- 01A1300170
- 01A1300201
- 01A130042001A1300545
Distribution
Part of a larger recall action
This product is one of 6 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.
See all 6 products in this recall →Related recalls
Same manufacturer · Teleflex Medical
See all →- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- ModerateTeleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
Same hazard · gas leakage
See all →- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- HighIntersurgical Smoothbore Breathing System Recalled for Incorrect Exhalation Port
FDA (Devices) · 2021-01-06
- SevereTeleflex Medical Recalls Taut Intraducers Due to Gas Leakage Risk
FDA (Devices) · 2015-11-25
- CriticalMaquet FLOW-i Anesthesia System Recalled for Gas Leakage Risk
FDA (Devices) · 2015-06-17
- HighTeleflex Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage
FDA (Devices) · 2014-04-09