Medline Laceration Tray Procedure Kits Recalled for Syringe Defects
Medline procedure kits containing plastic syringes affected by an FDA safety alert are being recalled. The syringes may leak or break, posing a potential risk to patient health.
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: FDA Class II medical device recall for plastic syringes with quality defects (leaks, breakage) that may pose patient health risks. No reported illnesses or injuries, making this a theoretical risk-of-harm scenario.
Plain-English summary
Medline Industries is recalling Laceration Tray procedure kits (Pack Number DYNJ17328B, Lot 21LBA554A). The kits contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The recall involves 108 units distributed worldwide, including throughout the United States and Canada.
The plastic syringes in these kits have been identified with quality issues including leaks, breakage, and other defects. These defects may pose a risk to patient health.
The recalled product
- Product
- Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kit
- Affected units
- 108
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)
- 1) Pack Number DYNJ17328B: UDI/DI 10080196232895 (each) 40080196232896 (case)
- Lot Number 21LBA554A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 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 19 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 due to leak and breakage risk
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 CV Neonatal Procedure Kits Recalled Due to Syringe Quality Issues
FDA (Devices) · 2025-04-02
Similar recalls
- HighMedline Circumcision Tray Kits Recalled for Defective Syringes
FDA (Devices) · 2024-09-04
- HighMedline procedure kits with defective plastic syringes recalled due to leak and breakage risk
FDA (Devices) · 2025-04-02
- HighMedline Procedural Kits with Defective Syringes Recalled Worldwide
FDA (Devices) · 2024-09-04
- HighMedline Procedural Kits Recalled for Syringe Quality Defects
FDA (Devices) · 2024-09-04
- HighMedline C-Section Procedure Kits Recalled for Defective Syringes
FDA (Devices) · 2025-03-26
- HighMedline surgical procedure kits recalled due to defective plastic syringes
FDA (Devices) · 2024-09-04