Medline Medical Convenience Kits Recalled Due to Plastic Syringe Defects
Medline is recalling multiple convenience kits containing plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak or break, potentially posing a risk to patient health.
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 medical devices (plastic syringes in clinical kits). No illnesses or injuries have been reported in the source text. However, the defects (leaks, breakage) in syringes used in blood draws and infusions represent potential harm in a high-risk medical device context where injury has not yet been reported, meeting the criterion for High severity.
Plain-English summary
Medline Industries is recalling multiple medical convenience kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The affected kits are used for blood culture collection, blood draws, infusions, and related clinical procedures in hospital and laboratory settings.
The plastic syringes in these kits have been identified with quality issues including leaks and breakage. These defects may pose a risk to patient health and medical device performance.
The recall affects healthcare facilities, hospitals, laboratory centers, and clinical settings worldwide that received affected lot numbers. Healthcare providers should stop using affected kits immediately and contact Medline Industries for instructions on replacement or return. Patients or providers with questions should consult the FDA website or the manufacturer for the complete list of affected products and lot numbers.
The recalled product
- Product
- Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A; 4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A; 5) LCPH LAB DRAW KIT ,
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leak
- syringe-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)
- BP115
- Lot Number 21BBG338
- Lot Number 21CBE353
- Lot Number 21CBJ050
- DYLAB1044
- Lot Number 23GBM782
- DYNDA1431A
- Lot Number 2020012890
- DYNDA1683A
- Lot Number 2019011790
- Lot Number 2019032590
- Lot Number 2019042390
- Lot Number 2019072390
- Lot Number 2019090990
- Lot Number 2019102390
- Lot Number 2019112290
- Lot Number 2020030990
- DYNDH1641A
- Lot Number 21JBE248
- Lot Number 21JBY828
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
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