Medline Convenience Kits Recalled Due to Potential Packaging Seal Failures
Medline Industries is recalling certain sterile convenience kits due to potential weak or open seals on breather pouches used for packaging. Compromised seals could affect 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: FDA Class II recall with no reported illnesses or injuries. The hazard is a theoretical risk to product sterility from compromised packaging seals on sterile medical device kits. Per the rubric, risk-of-harm products without reported injuries score as High (3).
Plain-English summary
Medline Industries, LP is recalling select Medline Convenience kits, specifically model PRECIP TRAY (MNS12590), due to potential open or weak seals on the breather pouches used for packaging these sterile products.
The affected kits were distributed worldwide, including in the United States, Canada, Mexico, Panama, and the U.S. Virgin Islands. A total of 45 units have been identified with the defect, identified by lot number 24IBH166.
The compromised seals on the breather pouches could allow the sterile packaging to be compromised, potentially affecting the sterility of the contained medical devices. This poses a risk to patients who receive procedures using these kits.
If you have received or used these kits, contact Medline Industries or your healthcare facility for guidance on whether your inventory is affected.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS12590
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kits
- Hazard
- packaging-seal-failure
- contamination-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 (4)
- 1) MNS12590
- UDI-DI: 10653160342052(each)
- 40653160342053(case)
- Lot Number: 24IBH166
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