The Recall Desk
HighFDA (Devices)·Z-0550-2023·Announced 2022-12-21

Stradis Healthcare Endo Pack Surgical Trays Recalled for Incomplete Seal

Stradis Healthcare is recalling Endo Pack surgical trays (Item 682-509) because manufacturing defects may result in incompletely sealed outer bags, potentially compromising kit sterility. Products were distributed in the US and Canada.

What this means for you

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: Class II FDA medical device recall for sterile surgical trays. An incompletely sealed outer bag may compromise the kit's sterility and create contamination risk. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High (Score 3) criterion.

Plain-English summary

Stradis Healthcare is recalling Endo Pack medical procedure trays, Item No. 682-509, due to a manufacturing defect. The outer bag of affected units may be incompletely sealed, which may result in a breach of the sterility of the kit.

The recalled product was distributed nationwide in the United States and in Canada. The affected lot number is 22256490827. The product can be identified using UDI/DI case code M7526825091 and UDI/DI kit code M7526825090.

The recalled product

Product
STRADIS HEALTHCARE, Endo Pack, Item No.682-509,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical/Medical Procedure Kits
Hazard
  • seal-defect
  • sterility-loss

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 (3)

  • UDI/DI (case) M7526825091
  • UDI/DI (kit)M7526825090
  • Serial/Lot Numbers: 22256490827

Distribution

Distributed nationwide across the United States.

Related recalls

Same category