The Recall Desk
HighFDA (Devices)·Z-0489-2023·Announced 2022-12-21

Surgical dental procedure kits recalled due to incomplete bag sealing

Stradis Healthcare is recalling surgical and dental procedure kits due to manufacturing defects that may result in incomplete outer bag sealing and compromised sterility.

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 where injury has not yet been reported. Incomplete outer bag seals may compromise kit sterility, creating potential for infection during surgical and dental procedures. No illnesses or injuries have been documented.

Plain-English summary

Stradis Medical, LLC, doing business as Stradis Healthcare, is recalling surgical and dental procedure kit products sold under the STRADIS HEALTHCARE brand, Item No. 40649ECS. The recall involves units with UDI/DI (case) M75240649ECS1, UDI/DI (kit) M75240649ECS0, and Serial/Lot Number 22270491425.

These kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed. An incomplete seal may result in a breach in the sterility of the kit.

The affected product was distributed nationwide in the United States and Canada.

The recalled product

Product
STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Dental Kit
Hazard
  • incomplete-seal
  • sterility-breach

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) M75240649ECS1
  • UDI/DI (kit)M75240649ECS0
  • Serial/Lot Numbers: 22270491425

Distribution

Distributed nationwide across the United States.

Related recalls

Same category