Merit Medical Recalls 1 mL Medallion Syringes Due to Plunger Tip Defect
Merit Medical Systems is voluntarily recalling 1 mL Medallion Syringes because of a defect in the syringe plunger tip.
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: The recall involves a medical device with a functional defect (plunger tip) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. is conducting a voluntary field action for 1 mL Medallion Syringes. The recall is due to a defect with the syringe plunger tip.
The affected products include 23,032 units distributed nationwide and to foreign consignees. Specific catalog numbers and lot numbers are listed in the official recall documentation.
Consumers should stop using the affected syringes and contact Merit Medical Systems for further instructions.
The recalled product
- Product
- 1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 23,032
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 (18)
- Lot Numbers: B617173
- H1082598
- H1082648
- H1082649
- H1082809
- H1085511
- H1085645
- H1092907
- H1085649
- H1097018
- H1085658
- H1085659
- H1085735
- H1089234
- H1089419
- H1090184
- H1101188
- H1101443.
Distribution
Distributed nationwide across the United States.
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