The Recall Desk
HighFDA (Devices)·Z-0506-2023·Announced 2022-12-21

General Surgery Procedure Kit Recalled for Sterility Concerns

Stradis Medical is recalling surgical procedure kits with potentially incomplete outer bag seals that may compromise sterility. The recall affects 35 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 an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is theoretical—potential sterility compromise from incomplete outer bag seals—creating a risk-of-harm for surgical patients, but without documented injury.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling the HENRY SCHEIN PROCEDURE KIT, Item No. 570-1508, a general surgery tray used in medical and surgical procedures. The recall involves 35 units.

The recalled kits may have incomplete seals on the outer bag, which could result in a breach of sterility. Surgical instruments that are not properly sterilized pose a risk to patient safety.

These kits were distributed nationwide in the United States and Canada. The affected lot number is 22252490204.

Healthcare facilities that received these kits should not use them. Facilities should contact Stradis Medical with questions about the recall.

The recalled product

Product
HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical / Procedure Kits
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) H65857015081
  • UDI/DI (kit)M75257015080
  • Serial/Lot Numbers: 22252490204

Distribution

Distributed nationwide across the United States.

Related recalls

Same category