Medline Sterile Convenience Kits Recalled Due to Weak Breather Pouch Seals
Medline is recalling 4,022 sterile procedure kits due to potential open or weak seals on breather pouches that could compromise sterility.
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: This is a Class II recall of medical device kits used for invasive procedures where compromised sterility could pose a risk of harm. No illnesses or injuries have been reported, and the hazard is theoretical (potential for weak seals), which per the rubric limits the score to at most 3.
Plain-English summary
Medline Industries is recalling 4,022 units of sterile convenience kits used for various medical procedures including angiography, cardiac catheterization, and interventional radiology. The affected kits include multiple models such as Angiography Drape Packs, Cardiac Cath Kits, and other procedure-specific packages.
The recall is due to a potential for open or weak seals on breather pouches used to package these sterile convenience kits. Breather pouches allow air and moisture exchange while maintaining sterility during storage. Weak or open seals could compromise the sterility of the packaged materials.
The affected kits were distributed worldwide to the United States, Canada, Mexico, Panama, and the Virgin Islands. Healthcare facilities and hospitals using these kits should identify affected units by checking the recalled model numbers and lot numbers. If affected units are identified, they should not be used. Facilities should contact Medline Industries for return or replacement instructions.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- compromised-sterility
- packaging-seal-failure
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 (20)
- 1) HCP075G
- UDI-DI: 10198459134456(each)
- 40198459134457(case)
- Lot Number: 24IBS428
- 2) DYNJ64354A
- UDI-DI: 10195327156312(each)
- 40195327156313(case)
- Lot Number: 24JBM450
- 3) 0M-CP01029D
- UDI-DI: 10888277858114(each)
- 40888277858115(case)
- Lot Number: 24JBM593
- 4) DYNJ81454B
- UDI-DI: 10198459100109(each)
- 40198459100100(case)
- Lot Number: 24JBN316
- 5) DYNJ51338C
- UDI-DI: 10193489241716(each)
- 40193489241717(case)
- Lot Number: 24JBN784
Distribution
Distributed nationwide across the United States.
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