The Recall Desk
HighFDA (Devices)·Z-0533-2023·Announced 2022-12-21

Surgical procedure trays with incomplete outer bag seals recalled

Stradis Healthcare is recalling Henry Schein labiaplasty procedure kits due to incomplete outer bag seals that could compromise sterility. The 42-unit recall affects products 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: FDA Class II recall involving potential sterility breach due to incomplete outer bag seals on surgical procedure trays. No illnesses or injuries reported, classifying this as a theoretical-risk recall rather than one with documented harm.

Plain-English summary

Stradis Medical, LLC (doing business as Stradis Healthcare) is recalling Henry Schein labiaplasty procedure kits due to a manufacturing defect affecting outer bag seals. The recall impacts 42 units identified as item number 570-3118 with lot number 22234491292.

Medical and surgical procedure trays in the recalled kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed. An incomplete seal creates a risk of sterility breach, potentially exposing surgical instruments or the surgical field to contamination during use.

The affected kits were distributed nationwide in the United States and Canada. Facilities that received these products should stop using them immediately and check their inventory against the lot number 22234491292 and the provided UDI codes.

Healthcare providers or facilities with affected kits should contact Stradis Healthcare or their medical device supplier. Patients who may have undergone procedures with affected kits should consult with their surgeon if they have concerns.

The recalled product

Product
HENRY SCHEIN, Labiaplasty PackItem No.570-3118,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Procedure Kit
Hazard
  • incomplete-seal
  • sterility-breach
  • contamination

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) H65857031181
  • UDI/DI (kit)M75257031180
  • Serial/Lot Numbers: 22234491292

Distribution

Distributed nationwide across the United States.

Related recalls

Same category