Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes
Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues. These defects 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: This is an FDA Class II recall of medical devices with identified quality defects (leaks and breakage) in plastic syringes used in medical procedures. The source reports no illnesses or injuries to date. Per the rubric, risk-of-harm medical devices with identified defects but no reported harm score as High (3).
Plain-English summary
Medline Industries, LP has recalled multiple medical convenience kits that contain plastic syringes. These kits are used in surgical procedures including angiography, neurosurgery, and ventriculoperitoneal shunt placement.
The recall was prompted by an FDA Safety Alert issued on March 19, 2024, regarding quality issues identified in the plastic syringes. The defects, including leaks, breakage, and other quality problems, may pose a risk to patient health.
The affected kits have been distributed worldwide to healthcare facilities and surgical centers. The recall encompasses numerous product pack numbers and lot numbers manufactured by Medline Industries, LP.
Healthcare providers using these kits should cease use of affected lots and verify whether their inventory includes recalled products using the provided lot and pack number information.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS78005
- 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 (20)
- 00-401327AA
- Lot Number 20AMA256
- Lot Number 20AMC142
- Lot Number 20BMB258
- Lot Number 20DMB109
- Lot Number 20GMB772
- Lot Number 20HMC035
- Lot Number 20JMA910
- Lot Number 20JMB656
- Lot Number 21CMA167
- Lot Number 21EMB860
- Lot Number 21FMC472
- Lot Number 21GMF286
- Lot Number 21HME693
- Lot Number 21IMC842
- Lot Number 21KMB315
- 00-401594R
- Lot Number 19LDA473
- Lot Number 20ADB972
- Lot Number 20CDC521
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 leak
See all →- HighMedline Procedure Kits Recalled Due to Defective Plastic Syringes
FDA (Devices) · 2025-04-02
- HighMedline Procedure Kits with Defective Plastic Syringes Recalled for Safety
FDA (Devices) · 2025-04-02
- HighMedline Surgical Procedure Kits Recalled for Defective Plastic Syringes
FDA (Devices) · 2025-04-02
- HighMedline Delivery and Labor Kits Recalled for Defective Plastic Syringes
FDA (Devices) · 2025-04-02
- HighMedline Laceration Tray Procedure Kits Recalled for Syringe Defects
FDA (Devices) · 2025-04-02