The Recall Desk
HighFDA (Devices)·Z-0490-2023·Announced 2022-12-21

Surgical Procedure Tray Recall Due to Incomplete Packaging Seal

Stradis Healthcare is recalling oral surgery trays with potentially incompletely sealed packaging that may compromise sterility. No illnesses reported.

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 with a theoretical hazard—sterility breach in surgical equipment—but no reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury score at most 3.

Plain-English summary

Stradis Healthcare is recalling oral surgery procedure trays due to a manufacturing defect that may result in an incompletely sealed outer bag. This incomplete seal could compromise the sterility of the surgical kit. No illnesses or injuries have been reported to date.

Healthcare facilities and practitioners who have received these kits should discontinue use. The affected product is the STRADIS HEALTHCARE Surg Pk (Item No. 40714IES), with affected lot numbers 22229490633, distributed nationwide in the United States and Canada. A total of 18 units are subject to this recall.

For more information or instructions on returning affected kits, contact Stradis Healthcare. The FDA classified this as a Class II recall.

The recalled product

Product
STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Procedure Kits
Hazard
  • sterility-breach
  • infection-risk

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 (4)

  • UDI/DI (case) M75240714IES1
  • UDI/DI (kit)M75240714IES0
  • Serial/Lot Numbers: 22229490633
  • 22229490633

Distribution

Distributed nationwide across the United States.

Related recalls

Same category