CLASS II Device recall · Reported 2 Apr 2014 · FDA Enforcement Report
Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm recalled
Teleflex Medical is recalling Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, distributed nationwide in the US. The recall was initiated on 11 Mar 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1280-2014
- FDA event ID
- 67710
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2014
- FDA classified
- 25 Mar 2014
- Reported
- 2 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 11 Mar 2014 | Recall initiated by company | |
| 25 Mar 2014 | Classified by FDA | +14 days |
| 2 Apr 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
Questions about this recall
Why was it recalled?
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Which lots are affected?
Product Code: 40591213, Lot Numbers: 01J1200416, 01K1200612, 01L1200160, 01A1300418, 01A1300427, 01E1300056, 01E1300052, 01E1300055
Where was it sold?
Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 67710This product is part of a recall event; the main page for the event is Weck¿ Vista" Optical Bladeless Laparoscopic Access Port recalled.
More recalls from Teleflex Medical
All 235| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS II | Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile recalled | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |