The Recall Desk
HighFDA (Devices)·Z-1109-2023·Announced 2023-02-22

Surgical convenience kits recalled for compromised sterility packaging

MEDLINE PAIN TRAY surgical convenience kits (120 units, Lot #22EBA798) are recalled nationwide because a perforated outer bag compromises the sterile barrier. Only the contents inside the kit's inner wrapping remain sterile.

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 FDA Class II recall addresses a compromised sterile barrier in surgical kits. No illnesses or injuries have been reported; the hazard represents a risk-of-harm scenario in a medical device context where packaging integrity is critical for safe use.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling 120 units of MEDLINE PAIN TRAY surgical convenience kits (Lot #22EBA798, GTIN 10193489720594) that were distributed nationwide.

The kits are recalled because a perforated outer bag fails to maintain the intended sterile barrier. Although the contents inside the kit's inner wrapping remain sterile, the compromised packaging cannot provide a fully sterile surgical environment.

Healthcare facilities and individuals who received these kits should review their inventory against this recall notice. Compromised packaging in surgical applications can pose a risk of bacterial contamination or infection if the outer barrier is breached.

The recalled product

Product
Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • sterility-compromise
  • contamination-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 (2)

  • GTIN 10193489720594
  • Lot # 22EBA798

Distribution

Distributed nationwide across the United States.