Medline LINQ Surgical Trays Recalled for Compromised Pouch Seals
Medline has recalled LINQ TRAY surgical kits with breather pouch seal openings that could compromise sterility. The recall affects 40 kits distributed nationwide; no injuries have been reported.
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 medical device recall with no reported illnesses or injuries. The hazard—compromised sterility in surgical kit pouches—represents a risk of harm in a critical medical setting, meeting the rubric criterion for Level 3 (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Medline Industries has recalled MEDLINE LINQ TRAY (REF DYNJ65880A), a convenience kit used in medical and surgical procedures. The recall was issued because some breather pouches in the sterile surgical kits show openings in the seal.
The affected product is Lot Number 22DBJ856, with a GTIN of 40195327002535. A total of 40 kits were distributed nationwide across California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas.
Seal openings in the breather pouches could potentially compromise the sterility of the surgical kit. Medline received complaints regarding this issue. No illnesses or injuries have been reported as of the recall announcement.
If you have received these surgical kits, contact Medline Industries for guidance on product handling and any necessary corrective actions. Healthcare facilities should review their inventory and follow proper sterile procedures for any affected products.
The recalled product
- Product
- MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Hazard
- seal-defect
- sterility-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 (01) 40195327002535
- Lot Number 22DBJ856
Distribution
Distributed nationwide across the United States.
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