CLASS II Device recall · Reported 9 Apr 2014 · FDA Enforcement Report
Weck Vista Cannula-only recalled by Teleflex Medical
Teleflex Medical is recalling Weck Vista Cannula-only, 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-1324-2014
- FDA event ID
- 67819
- Recalling firm
- Teleflex Medical, Durham, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2014
- FDA classified
- 2 Apr 2014
- Reported
- 9 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 11 Mar 2014 | Recall initiated by company | |
| 2 Apr 2014 | Classified by FDA | +22 days |
| 9 Apr 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaints of leakage of insufflation gas through the device.
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
10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. 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 Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKansasKentuckyMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNorth Dakota
Questions about this recall
Why was it recalled?
Complaints of leakage of insufflation gas through the device.
Which lots are affected?
Lots - Catalog No. 405910C - 01G1200243, 01J1200226, 01L1200368, 01A1300177, 01D1300107, 01E1300140, 01E1300435, Catalog No. 405912C - 01J1200384, 01K1200725, 01L1200352, 01D1300319
Where was it sold?
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, 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
5 other products · FDA event 67819This product is part of a recall event; the main page for the event is Weck Vista Optical Bladeless Laparoscopic Access Port recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Weck Vista Optical Bladeless Laparoscopic Access Port recalled | Teleflex Medical | Packaging Defects | Nationwide | |
| CLASS II | Weck Vista Universal Cone Open Access recalled by Teleflex Medical | Teleflex Medical | Packaging Defects | Nationwide | |
| CLASS II | Weck Vista Universal Laparoscopic Port, Size recalled | Teleflex Medical | Packaging Defects | Nationwide | |
| CLASS II | Weck Vista Universal Cannula recalled by Teleflex Medical | Teleflex Medical | Packaging Defects | Nationwide | |
| CLASS II | 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length recalled | Teleflex Medical | Packaging Defects | Nationwide |
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 Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |