Non-sterile orthopedic procedural trays recalled for potential sterile packaging breach
Medline Industries recalls non-sterile orthopedic procedural trays that may contain sterile blades capable of puncturing the protective foil packaging, compromising sterile barriers.
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 classification. No illnesses or injuries have been reported. The hazard is theoretical—a potential for packaging breach—rather than an actual incident. Per rubric criteria, risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
Medline Industries, LP is recalling non-sterile orthopedic procedural trays labeled 'ORTHO TRAUMA' (Item Number DYNJ908295) due to a potential packaging integrity issue.
The trays contain sterile blades that may puncture the outer foil protective layer, creating a breach in the packaging. This breach could compromise the sterile barrier intended to protect the equipment and materials within the kit.
The recall affects 216 units distributed nationwide in Arkansas, Maryland, Washington, and Wisconsin. The affected lots are 22IBN449 and 22JBQ931.
If you have received these trays, do not use them. Contact Medline Industries for instructions on returning or replacing the affected products.
The recalled product
- Product
- Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- packaging-breach
- sterile-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 (5)
- Item Number: DYNJ908295
- UDI/GTIN Case: 40195327029570
- UDI/GTIN Each: 10195327029579
- Lot Numbers: 22IBN449
- 22JBQ931
Distribution
Distributed nationwide across the United States.
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