Surgical Seal Packaging May Compromise Sterility in Laparoscopic Devices
Surgical Innovations Ltd recalls YelloPort Elite Universal Seals due to potential holes in packaging that may affect product sterility. Worldwide distribution affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall without reported illnesses or injuries. The theoretical hazard—potential packaging defects affecting sterility of a surgical device—qualifies as a risk-of-harm product. No injury has been reported to date, placing this at the High severity level per the rubric.
Plain-English summary
Surgical Innovations Ltd is recalling all lots of the YelloPort Elite Universal Seal, a device used in laparoscopic surgical procedures. The recall is identified by UDI/DI code 05051986001562.
The FDA has identified that the product packaging may contain small holes which could affect the sterility of the device. Sterile packaging is critical for surgical instruments used in internal procedures to prevent contamination and maintain safety.
The affected devices were distributed worldwide, including in the United States in Florida, Indiana, Washington, and Massachusetts. International distribution includes Canada, Mexico, Australia, Japan, and numerous other countries listed in the FDA recall notice.
Healthcare providers and surgical facilities should verify their device inventory against this recall. Contact Surgical Innovations Ltd or the FDA for information regarding device status and recommended actions.
The recalled product
- Product
- YelloPort Elite Universal Seal. For use in laparoscopic procedures.
- Manufacturer
- Surgical Innovations Ltd
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Lots
- UDI/DI:05051986001562
Distribution
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