The Recall Desk
HighFDA (Devices)·Z-0558-2023·Announced 2022-12-21

Surgical Procedure Trays Recalled Due to Potentially Compromised Sterility

Stradis Healthcare is recalling 75 units of surgical procedure trays because their outer bags may be incompletely sealed, potentially compromising 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 an FDA Class II recall involving a manufacturing defect that may compromise the sterility of surgical procedure trays. The potential for contamination or infection from non-sterile surgical instruments represents a material risk of harm.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling STRADIS HEALTHCARE SURGE-O-VAC .125" GREEN surgical procedure trays (Item No. SS077225). This recall involves 75 units with Lot Number 22255490439, distributed nationwide in the United States and Canada.

Medical and surgical procedure trays underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed. An incompletely sealed outer bag may result in a breach in the sterility of the kit, which is essential for safe use in surgical and medical procedures.

The recalled product

Product
STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Instruments
Hazard
  • sterility-breach
  • incomplete-seal

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) M752SS0772251
  • UDI/DI (kit)M752SS0772251
  • Serial/Lot Numbers: 22255490439

Distribution

Distributed nationwide across the United States.

Related recalls

Same category