Medline Sterile Procedure Kits Recalled Due to Weak Breather Pouch Seals
Medline is recalling sterile convenience kits used for various procedures because breather pouches may have open or weak seals, which could compromise sterility during storage or transport.
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 sterile medical device packaging defect where weak seals could compromise sterility during storage or transport. Although no illnesses or injuries have been reported, weak seals on sterile procedure kits represent a risk-of-harm scenario due to potential contamination during clinical use.
Plain-English summary
Medline Industries, LP is recalling three models of sterile convenience kits (ANGIO CONSOLIDATED PACK Model DYNJHTCAD1, ANGIOGRAPHY TRAY-LF Model DYNJ05350V, and ANGIOGRAPHY PACK Model DYNJ38144C) used for various medical procedures. The kits are being recalled due to the potential for open or weak seals on breather pouches used for packaging these sterile items.
Breather pouches are part of the sterile field packaging. If seals are compromised, the sterility assurance of the kits can be lost, potentially exposing patients to contamination risk. A total of 2,118 units have been distributed worldwide, including the United States, Canada, Mexico, Panama, and the Virgin Islands.
Healthcare facilities, ambulatory surgical centers, and hospitals that have received these kits should contact Medline Industries immediately. Patients should consult with their healthcare provider if they had a procedure using one of these affected kits.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seals
- contamination-risk
- sterility-compromise
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 (12)
- 1) DYNJHTCAD1
- UDI-DI: 10888277087583(each)
- 40888277087584(case)
- Lot Number: 24JBS743
- 2) DYNJ05350V
- UDI-DI: 10193489316629(each)
- 40193489316620(case)
- Lot Number: 24JBU500
- 3) DYNJ38144C
- UDI-DI: 10193489854916(each)
- 40193489854917(case)
- Lot Number: 24KBD294
Distribution
Distributed nationwide across the United States.
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