The Recall Desk
HighFDA (Devices)·Z-0501-2023·Announced 2022-12-21

Stradis Healthcare surgical procedure trays recalled for incomplete packaging seals

Stradis Medical is recalling medical and surgical procedure trays with incomplete outer bag sealing, which may compromise sterility. The recall affects 150 units distributed nationwide 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: This is a risk-of-harm medical device recall with no reported illnesses or injuries. A potential breach in sterility of surgical procedure trays poses significant risk, meeting the rubric criterion for High severity.

Plain-English summary

Stradis Medical, LLC is recalling STRADIS HEALTHCARE PROBE COVER W/GEL PACK (Item No. 525-071) general surgery trays.

During manufacturing, certain conditions resulted in incomplete sealing of the outer bag, which may result in a breach in the sterility of the kit.

150 units were distributed nationwide in the United States and Canada. The recall includes items with Serial/Lot Number 22252491061, UDI/DI (case) M7525250711, and UDI/DI (kit) M7525250710.

The recalled product

Product
STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Procedure Tray
Hazard
  • sterility-breach
  • contamination

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) M7525250711
  • UDI/DI (kit)M7525250710
  • Serial/Lot Numbers: 22252491061

Distribution

Distributed nationwide across the United States.

Related recalls

Same category