CLASS II ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report
Product/Part: YelloPort Elite Pencil Point Trocar/ET1207503 recalled
Surgical Innovations is recalling Product/Part: YelloPort Elite Pencil Point Trocar/ET1207503, distributed in Massachusetts. The recall was initiated on 20 Jan 2022 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-1852-2022
- FDA event ID
- 90801
- Recalling firm
- Surgical Innovations, Leeds, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Jan 2022
- FDA classified
- 29 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 20 Jan 2022 | Recall initiated by company | |
| 29 Sep 2022 | Classified by FDA | +252 days |
| 5 Oct 2022 | 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
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
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
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
Where it was distributed
US: MA
Questions about this recall
Why was it recalled?
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
Which lots are affected?
Part/UDI-DI/Lot: ET1207503/05051986012438/735479, EA10NH/05051986012100/734029
Where was it sold?
US: MA
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 90801This product is part of a recall event; the main page for the event is Product/Part: YelloPort Plus Cannula + Luer/YC0507001 recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Product/Part: YelloPort Plus Cannula + Luer/YC0507001 recalled | Surgical Innovations | Sterility | MA |
More recalls from Surgical Innovations
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | YelloPort Elite recalled by Surgical Innovations | Surgical Innovations | Sterility | MA |
| Device | CLASS II | YelloPort Elite recalled by Surgical Innovations | Surgical Innovations | Sterility | MA |
| Device | CLASS II | Product/Part: YelloPort Plus Cannula + Luer/YC0507001 recalled | Surgical Innovations | Sterility | MA |
| Device | CLASS II | YelloPort Elite Universal Seal recalled by Surgical Innovations | Surgical Innovations | Sterility | Nationwide |
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| 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 |