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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 120
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.
Part of a larger recall action
This product is one of 20 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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