Merit Medical Systems, Inc. recalls Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe…
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.
Read the official notice →- Date
- 2026-10-07
- Country
- United States
- Brand
- Merit Medical Systems
- Product
- Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of CA, GA and the…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-06-24
USMerit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180…
Due to unsealed portions of pouches.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution in the states and territory AL, AZ,…Official notice →- 2026-05-06
- US
Merit Medical Systems, Inc. recalls Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
FDA · DeviceMerit Medical Systems, Inc.US Nationwide distribution in the state of CO.Official notice → - 2026-04-01
- US
Merit Medical Systems, Inc. recalls CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K,…
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss…
FDA · DeviceMerit Medical Systems, Inc.Worldwide distribution: US (nationwide) to states of: TX, LA, OR, NM, MI, FL,…Official notice → - 2026-01-28
- US
Merit Medical Systems, Inc. recalls Allwell Inflation Device, for angiographic use REF: IS-30-A
Inflation device handle may detach from the syringe during procedure.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ,…Official notice → - 2025-11-26
- US
Merit Medical Systems, Inc. recalls PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A,…
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
FDA · DeviceMerit Medical Systems, Inc.US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS,…Official notice → - 2025-09-17
- US
Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329…
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY,…Official notice →
Other drugs & medical recalls in the United States
- 2026-10-07
- US
Percussionaire Corporation recalls Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents,…
FDA · DevicePercussionaire CorporationWorldwide - US Nationwide distribution including in the states of CA, PA, OK,…Official notice → - US
Philips North America recalls Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software…
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction…
FDA · DevicePhilips North AmericaWorldwide distribution - Nationwide and the countries of Algeria, Argentina,…Official notice → - US
NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
- US
Heraeus Medical GmbH (Dental Division) recalls PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl…
Potential for monomer liquid leakage.
FDA · DeviceHeraeus Medical GmbH (Dental Division)Worldwide distribution - US Nationwide and the countries of Aland Islands,…Official notice → - US
Olympus Corporation of the Americas recalls Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
FDA · DeviceOlympus Corporation of the AmericasInternational distribution to the country of Japan.Official notice → - US
Cardinal Health 200, LLC recalls Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2)…
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user…
FDA · DeviceCardinal Health 200, LLCUS Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.Official notice →