YelloPort Elite - Laparoscopic Port Access SystemRecalls & reported problems across all models
Surgical Innovations Limited · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one YelloPort Elite - Laparoscopic Port Access System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 4 models of YelloPort Elite - Laparoscopic Port Access System by Surgical Innovations Limited in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Nov 1, 2021 and Mar 3, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).
2 FDA recall records name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
YelloPort Elite - Laparoscopic Port Access System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 2, 2022Class IICompleted
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
Z-1396-2022 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 20, 2022Class IIOpen, Classified
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
Z-1852-2022 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported YelloPort Elite - Laparoscopic Port Access System problems
Device problems
- Device Markings/Labelling Problem2
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
YelloPort Elite - Laparoscopic Port Access System models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- YelloPort Elite - Laparoscopic Port Access System ET1207503Laparoscope, General & Plastic Surgery1 recall1 report
- YelloPort Elite - Laparoscopic Port Access System EA512USLaparoscope, General & Plastic Surgery1 recall0 reports
- YelloPort Elite - Laparoscopic Port Access System EA10NHLaparoscope, General & Plastic Surgery1 recall0 reports
- YelloPort Elite - Laparoscopic Port Access System EA12NHLaparoscope, General & Plastic Surgery2 reports
Recent YelloPort Elite - Laparoscopic Port Access System adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2022Device Markings/Labelling Problem
DEVICE WITH INCORRECT STERILITY STATUS DISCOVERED DURING CONTAINMENT ACTIVITY AT MANUFACTURER (SURGICAL INNOVATIONS LTD) DURING INVESTIGATIONS OF CUSTOMER COMPLAINT (B)(4). DEVICES ARE MARKED AS 'STERILE' SINGLE-USE BUT ARE NON-STERILE REUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13659006 ↗MalfunctionJan 17, 2022Device Markings/Labelling Problem
AFTER RECEIPT, THE CUSTOMER FOUND THAT THE DEVICE WAS LABELLED "STERILE R", WITH A DUE DATE, AND DISPOSABLE SYMBOL ON THE LABEL DESPITE NON STERILE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13265044 ↗MalfunctionNov 1, 2021Product Quality Problem
CUSTOMER COMPLAINED THAT THE DEVICE WAS NOW LABELLED AS 'SINGLE-USE' WHEREAS PREVIOUS PURCHASES OF THE SAME DEVICE HAD NOT BEEN LABELLED AS 'SINGLE-USE'.
Patient problems: Insufficient Information
MAUDE report 12728365 ↗
Other Surgical Innovations Limited products
All Surgical Innovations Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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