Recall archive / FDA device enforcement
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For us... — FDA record Z-1852-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 20, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
- Reason
- Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
- Classification
- Class II
- Recalling firm
- Surgical Innovations Ltd
- Quantity
- 19
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1852-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Part/UDI-DI/Lot: ET1207503/05051986012438/735479, EA10NH/05051986012100/734029 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: MA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 5, 2022
- Recall initiation date
- Jan 20, 2022
- Center classification date
- Sep 29, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.