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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90801

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 20, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Surgical Innovations Ltd

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.

Z-1852-2022
Recall number
Z-1852-2022
Initiated
January 20, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Surgical Innovations Ltd
Quantity
19

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

Code information

Part/UDI-DI/Lot: ET1207503/05051986012438/735479, EA10NH/05051986012100/734029

Distribution pattern

US: MA

device · product 2 of 2

Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.

Z-1853-2022
Recall number
Z-1853-2022
Initiated
January 20, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Surgical Innovations Ltd
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

Code information

Part/UDI-DI/Lot: YC0507001/05051986001890/735652

Distribution pattern

US: MA