The Recall Desk
HighFDA (Devices)·Z-0504-2023·Announced 2022-12-21

Surgical Trays Recalled Due to Incomplete Bag Sealing

Stradis Healthcare is recalling surgical trays due to incomplete outer bag sealing that may compromise sterility of the surgical kit.

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: FDA Class II recall involving a medical device with risk-of-harm potential due to sterility breach in surgical instruments. The source text does not report illnesses or injuries, placing this at Score 3 rather than Score 4, which requires reported hospitalizations or significant injuries.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling the HENRY SCHEIN Novasure Pack general surgery trays (Item No. 570-1462) due to manufacturing conditions that may result in incomplete outer bag sealing.

The incomplete seal may allow the sterility of the surgical kit to be compromised. The recall affects 15 units distributed nationwide in the United States and Canada.

Healthcare facilities and surgical centers that have received these trays should stop using them and contact Stradis Healthcare for further instructions.

Affected units can be identified by UDI/DI (case) H65857014621, UDI/DI (kit) M75257014620, and Serial/Lot Number 22230491082.

The recalled product

Product
HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Tray
Hazard
  • sterility-breach
  • seal-defect

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) H65857014621
  • UDI/DI (kit)M75257014620
  • Serial/Lot Numbers: 22230491082

Distribution

Distributed nationwide across the United States.

Related recalls

Same category