Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
Medline is recalling PAIN PACK and PAIN TRIAL PACK sterile convenience kits due to potential open or weak seals on breather pouches, which could compromise 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 an FDA Class II recall of sterile medical device kits with potential seal compromise that could affect product sterility. No illnesses or injuries have been reported, placing this at the High level per the rubric's criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling select PAIN PACK (Model DYNJ67577A, Lot 24JBX252) and PAIN TRIAL PACK (Model DYNJ67576A, Lot 24JBX286) sterile convenience kits due to a potential for open or weak seals on the breather pouches used for packaging. Compromised seals could affect the sterility of these kits.
The products were distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the Virgin Islands, with approximately 40 units involved in this recall.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- open-seal
- compromised-sterility
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 (8)
- 1) DYNJ67577A
- UDI-DI: 10193489980349(each)
- 40193489980340(case)
- Lot Number: 24JBX252
- 2) DYNJ67576A
- UDI-DI: 10193489980455(each)
- 40193489980456(case)
- Lot Number: 24JBX286
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