FDA-Device2026-04-08Class IIPACKAGING DEFECT
Medline Sterile Radiology Procedure Kits recalled for compromised packaging
What this means
Medline Industries identified a potential breach in the sterile pouch packaging of one lot of Sterile Radiology Procedure Kits (Model DYNDH1491B). This breach may allow the kit to lose its sterile condition. No injuries have been reported.
- Do not use kits from lot number 25GBB924.
- Contact your supplier or Medline Industries for replacement kits or further instructions.
- If you have already used a kit from this lot, consult your healthcare provider if you have concerns.
The agency's original wording
Hazard
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of MN.
Affected count
420 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Sterile Radiology Procedure Kits, Model Number DYNDH1491B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1693-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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