Medline Medical Convenience Kits Recalled Due to Plastic Syringe Quality Issues
Medline is recalling specific medical convenience kits because they contain plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose 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: The recall is classified as FDA Class II, and the source states that quality issues 'may pose a risk to patient health' without reporting specific injuries or hospitalizations, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling specific medical convenience kits, including various GYN Laparoscopy, Robotic, and Liver Procedure kits. The recall is necessary because these kits contain plastic syringes that are affected by an FDA Safety Alert issued on March 19, 2024.
The affected syringes have identified leaks, breakage, and other quality issues. These defects may pose a risk to patient health. The recall covers worldwide distribution of the listed pack numbers and lot numbers.
Healthcare facilities and consumers should stop using the affected kits and contact Medline for further instructions or a replacement.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS760053D ; 3) TUBAL LIGATION CDS, Pack Number CDS760053G ; 4) TUBAL LIGATION CDS, Pack Number CDS760053I ; 5) TUBAL LIGATION CDS, Pack Number CDS760053J ; 6) GYN
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
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)
- CDS760049AB
- Lot Number 19ABQ398
- Lot Number 19CBC288
- Lot Number 19DBJ667
- Lot Number 19FBS065
- Lot Number 19SBD646
- CDS760053D
- Lot Number 19HBC984
- Lot Number 19IBL466
- Lot Number 19IBM566
- Lot Number 19VBH599
- CDS760053G
- Lot Number 20FBV500
- Lot Number 20GBD263
- Lot Number 20IBG285
- Lot Number 20JBL101
- Lot Number 20JBV510
- Lot Number 20LBT279
- Lot Number 21ABS479
- CDS760053I
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 81 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 81 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · device defect
See all →- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22