Medline Convenience Kits with Defective Plastic Syringes Recalled
Medline is recalling convenience kits containing plastic syringes with quality issues including leaks and breakage that may affect patient safety. The kits have been distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involving defective syringes with leaks and breakage that may pose a risk of harm to patients. No illnesses or injuries have been reported in the source material. Per the rubric, risk-of-harm products where injury has not yet been reported are scored at 3 (High).
Plain-English summary
Medline Industries, LP is recalling Admit Kit Pillow Box convenience kits (Pack Number DYKA1389, Lot Number 21IMA285) containing plastic syringes affected by an FDA Safety Alert issued on March 19, 2024.
The recalled kits contain syringes with identified quality issues including leaks and breakage. These defects may pose a risk to patient health and proper medication administration.
The convenience kits have been distributed worldwide. Consumers and healthcare facilities should stop using these kits and contact Medline Industries for further instructions regarding the recall.
The recalled product
- Product
- Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (2)
- DYKA1389
- Lot Number 21IMA285
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 · syringe defect
See all →- HighMedline Procedure Kits Recalled Due to Defective Plastic Syringe Quality Issues
FDA (Devices) · 2025-04-02
- HighMedline Procedure Kits With Defective Plastic Syringes Recalled
FDA (Devices) · 2025-04-02
- HighMedline C-Section Procedure Kits Recalled for Defective Syringes
FDA (Devices) · 2025-03-26
- HighMedline surgical convenience kits recalled due to defective plastic syringes
FDA (Devices) · 2024-09-18
- HighMedline CYSTO PACK Convenience Kits Recalled for Defective Syringes
FDA (Devices) · 2024-09-18
Similar recalls
- HighMedical Convenience Kits with Defective Plastic Syringes Recalled
FDA (Devices) · 2024-09-04
- HighMedical Convenience Kits with Plastic Syringes Recalled Due to Quality Defects
FDA (Devices) · 2024-09-04
- HighMedline Medical Convenience Kits with Plastic Syringe Defects
FDA (Devices) · 2024-09-04
- HighMedline Medical Convenience Kits with Syringes Recalled for Leaks and Breakage
FDA (Devices) · 2024-09-04
- HighMedline recalls medical convenience kits with defective plastic syringes
FDA (Devices) · 2024-09-04
- HighMedical Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage
FDA (Devices) · 2024-09-04