CLASS II Device recall · Reported 19 Oct 2016 · FDA Enforcement Report
5 Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport recalled
Banyan Medical is recalling 5 Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport, distributed in Indiana, Tennessee. The recall was initiated on 7 Sep 2016 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-0075-2017
- FDA event ID
- 75274
- Recalling firm
- Banyan Medical, Warwick, RI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Sep 2016
- FDA classified
- 13 Oct 2016
- Reported
- 19 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 Sep 2016 | Recall initiated by company | |
| 13 Oct 2016 | Classified by FDA | +36 days |
| 19 Oct 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential lack of assurance of sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
Where it was distributed
IN, TN
Questions about this recall
Why was it recalled?
Potential lack of assurance of sterility
Which lots are affected?
Lot Numbers:140718, 160209
Where was it sold?
IN, TN
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
1 other product · FDA event 75274| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 5 Regular Pyramidal Trocar and 2x Cannula recalled by Banyan Medical | Banyan Medical | Sterility | IN, TN |
More recalls from Banyan Medical
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 5 Regular Pyramidal Trocar and 2x Cannula recalled by Banyan Medical | Banyan Medical | Sterility | IN, TN |
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 |