FDA-Device2026-04-08Class IIPACKAGING DEFECT
Medline Sterile Radiology Procedure Kits recalled for compromised packaging
OTHERNationwide distribution
Stop using Medline radiology kits lot 25GBB924
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.
Hazard
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
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 Industries, LP recalls
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- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline medical convenience kits with Namic Manifold recalled for particulate contamination
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