Medline Sterile Surgical Convenience Kits Recalled Due to Weak Breather Pouch Seals
Medline Industries is recalling 3,205 sterile surgical convenience kits with potential weak or open seals on their breather pouches. Seal defects may allow contamination and loss of product 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 medical device recall for potential seal defects on sterile surgical kits. No illnesses or injuries have been reported. However, weak or open seals on sterile medical device packages represent a potential risk of serious infection if devices are used in surgical procedures.
Plain-English summary
Medline Industries, LP is recalling 3,205 sterile surgical convenience kits due to a potential defect in product packaging. These convenience kits include 37 different surgical pack models used in cardiac, vascular, pacemaker, and other surgical procedures. The breather pouches used to package the kits may have weak or open seals that could compromise the sterility of the devices during storage and distribution.
The affected convenience kits were distributed worldwide to healthcare facilities in the United States, Canada, Mexico, Panama, and the U.S. Virgin Islands. The recall includes specific lot numbers for each of the 37 different kit models.
Healthcare facilities and other users who have received these kits should discontinue use immediately. Contact Medline Industries for instructions regarding the return or replacement of affected kits. Weak or open seals on sterile medical device packaging may allow contamination and compromise the safety of the devices if used in surgical procedures.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seal
- 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 (20)
- 1) DYNJ59310D
- UDI-DI: 10195327402396(each)
- 40195327402397(case)
- Lot Number: 24IBB643
- 2) DYNJ32436A
- UDI-DI: 10884389686614(each)
- 40884389686615(case)
- Lot Number: 24IBG295
- 3) DYNJ35586G
- UDI-DI: 10193489663235(each)
- 40193489663236(case)
- Lot Number: 24IBG343
- 4) DYNJ55343B
- UDI-DI: 10195327478056(each)
- 40195327478057(case)
- Lot Number: 24IBG535
- 5) DYNJ55343B
- Lot Number: 24IBH248
- 6) DYNJ65027B
- UDI-DI: 10193489471991(each)
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03