Merit Medical Systems, Inc. recalls Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe…
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Read the official notice →- Date
- 2024-10-23
- Country
- United States
- Brand
- Merit Medical Systems
- Product
- Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Merit Medical Systems recalls
- 2025-04-30
USMerit Medical Systems, Inc. recalls Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2025-04-02
- US
Merit Medical Systems, Inc. recalls Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
FDA · DeviceMerit Medical Systems, Inc.International distribution to the country of Japan.Official notice → - 2024-10-23
- US
Merit Medical Systems, Inc. recalls basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2024-10-02
- US
Merit Medical Systems, Inc. recalls Custom Procedure Kit, REF: K12T-11077
7F sheath introducers labeled as 7.5F
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA,…Official notice → - 2024-08-21
- US
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response…
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
FDA · DeviceMerit Medical Systems, Inc.U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice → - 2024-07-03
- US
Merit Medical Systems, Inc. recalls Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS…
Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel…
FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice →
Other drugs & medical recalls in the United States
- 2024-10-23
- US
LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2;…
As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause…
- US
Merit Medical Systems, Inc. recalls basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Stryker Corporation recalls 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement…
May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus,…
FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of Canada, Columbia.Official notice → - US
Olympus Corporation of the Americas recalls EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light…
Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.
- US
Kinova Inc recalls KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the…
Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting electrical leakage.
FDA · DeviceKinova IncWorldwide - US Nationwide distribution in the states of California, Missouri,…Official notice → - US
DATEX--OHMEDA, INC. recalls GE Heathcare Giraffe OmniBed; neo natal incubator
GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This…