Medline Convenience Kits Recalled for Syringe Leaks and Breakage
Medline is recalling convenience kits containing plastic syringes following an FDA safety alert. Identified leaks, breakage, and quality issues in these kits may pose a risk to patient health. The affected kits are distributed worldwide.
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 medical device recall with identified product defects (leaks and breakage) in safety-critical syringes. No illnesses or injuries reported, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medline Industries is recalling medical convenience kits containing plastic syringes. The recall affects ten different kit types, identified by specific pack numbers and lot numbers, distributed worldwide.
An FDA Safety Alert was issued on March 19, 2024, regarding these kits. Quality defects have been identified, including leaks, breakage, and other issues that may pose a risk to patient health.
The defects could affect the safe use of the syringes contained in these convenience kits. Anyone using these kits should verify whether they have any of the recalled lot numbers.
Those with affected kits should stop using them and consult the FDA recall notice for guidance on proper handling and next steps.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132701; 3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ; 4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ; 5) KIT ANGIO CSTM-SETON, P
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- breakage
- quality-defect
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)
- 129736
- Lot Number 20DKA054
- 132701
- Lot Number 24ADB481
- Lot Number 24ADA120
- Lot Number 23GDC081
- Lot Number 23DDC268
- Lot Number 23CDC677
- Lot Number 22LDA569
- Lot Number 22IDC180
- Lot Number 22IDA238
- Lot Number 22DDB501
- Lot Number 22DDA530
- Lot Number 22ADB638
- Lot Number 21KDB209
- Lot Number 21KDA233
- Lot Number 21JDA611
- Lot Number 21FDC090
- Lot Number 21EDB524
- Lot Number 21CDB488
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27