Medical procedure kits with defective plastic syringes recalled due to quality issues
Medline Industries is recalling Centurion procedure kits due to plastic syringes with defects including leaks and breakage. These defects may compromise patient safety during medical procedures.
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 recall of medical procedure kits with documented defects (leaks, breakage) in plastic syringes. The broad distribution and use in invasive procedures create genuine risk of patient harm, but no illnesses or injuries are reported in the source. This classification reflects the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling Centurion procedure kits due to plastic syringes affected by an FDA Safety Alert issued March 19, 2024. The syringes have been identified with leaks, breakage, and other quality defects that may pose risks to patient health.
The recall affects 39 different types of medical procedure kits distributed worldwide, including kits used for arterial line placement, biopsies, lumbar punctures, chest tube insertion, circumcision, delivery procedures, and various other invasive clinical procedures. Affected lot numbers span from 2018 through 2024.
These defects may compromise the integrity and sterility of procedure kits during clinical use. Healthcare providers should review the complete list of affected lot numbers provided in the FDA recall notice.
The recalled product
- Product
- Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) ARTHROGRAPH TRAY, Pack Number MNS12670A; 5) BIOPSY…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure 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)
- ART245C
- Lot Number 2023101990
- ART1170
- Lot Number 2022121990
- Lot Number 2023012790
- Lot Number 2023021590
- PT220
- Lot Number 2021061490
- Lot Number 2022011090
- MNS12670A
- Lot Number 2021060190
- Lot Number 2023022190
- Lot Number 2023101890
- SUT20455
- Lot Number 2023012390
- BT1060
- Lot Number 2020062490
- BT1015
- DYNDH1137C
- Lot Number 2021091490
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 8 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 8 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 leakage
See all →- HighMedline Procedure Kits With Defective Syringes Recalled Nationwide
FDA (Devices) · 2025-04-02
- HighMedline Procedure Kits Recalled for Defective Syringes Posing Patient Risk
FDA (Devices) · 2025-04-02
- HighMedline Surgical Procedure Kits Recalled for Syringe Leakage and Breakage
FDA (Devices) · 2025-04-02
- HighMedical Convenience Kits Recalled for Syringe Leaks and Breakage
FDA (Devices) · 2024-09-18
- HighMedline Medical Convenience Kits Recalled for Syringe Defects
FDA (Devices) · 2024-09-18
Similar recalls
- HighCenturion Procedure Packs with Plastic Syringes Recalled for Leaks and Breakage
FDA (Devices) · 2024-09-04
- HighCenturion Procedure Packs with Defective Syringes Recalled Worldwide
FDA (Devices) · 2024-09-04
- HighMedical procedure packs containing defective syringes recalled by Medline
FDA (Devices) · 2024-09-04
- HighCenturion Procedure Kits with Defective Syringes Recalled Worldwide
FDA (Devices) · 2024-08-14
- HighMedline procedure kits with defective plastic syringes recalled due to leak and breakage risk
FDA (Devices) · 2025-04-02
- SevereMedline Procedure Kits Recalled Due to Defective Syringes and Quality Issues
FDA (Devices) · 2024-08-14