Medline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage
Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and other quality defects that may pose a risk to patient health. 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: This is an FDA Class II recall for medical convenience kits with identified quality defects (leaks, breakage) that may pose a risk to patient health. No illnesses or injuries have been reported. The score reflects a risk-of-harm product where injury has not yet been reported, falling under the High severity category.
Plain-English summary
Medline Industries, LP is recalling multiple medical convenience kits containing plastic syringes due to quality defects identified through an FDA Safety Alert issued on March 19, 2024. The affected kits are used in various surgical and medical procedures including stereotactic, otology, laparoscopy, mediastinoscopy, rhinoplasty, and other surgical applications.
The recalled kits contain plastic syringes with identified leaks, breakage, and other quality issues that may pose a risk to patient health. Healthcare facilities should reference the FDA recall notice for the complete list of 26 affected pack numbers and their associated lot numbers to identify products in their inventory.
The worldwide distribution of these kits means healthcare providers in multiple countries may have received affected products. Healthcare facilities should consult the FDA recall information and contact Medline Industries for guidance on handling, return, or replacement of the recalled kits.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ; 4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ; 5) MEDIASTIN
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- leaking
- breakage
- quality-issue
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)
- CDS983173G
- Lot Number 21FBQ527
- Lot Number 21HBF657
- Lot Number 21IBE910
- Lot Number 21IBM809
- Lot Number 21JBJ185
- Lot Number 21KBM498
- Lot Number 22ABF773
- Lot Number 22BBH011
- Lot Number 19ABX210
- Lot Number 22OBM500
- Lot Number 22EBQ566
- Lot Number 19GBS147
- Lot Number 19IBG146
- Lot Number 19IBJ785
- Lot Number 19KBA219
- Lot Number 19KBA926
- Lot Number 20BBA113
- Lot Number 20CBP609
- Lot Number 20DBU576
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