Microcatheter and Infusion Systems Recalled Due to Sterility Concerns
Merit Medical Systems is recalling specific lots of microcatheter and infusion system devices because their sterility cannot be guaranteed. The devices were distributed worldwide including multiple US states and international locations.
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 sterile-critical medical devices where sterility cannot be guaranteed. No illnesses or injuries have been reported, but the risk of serious infection from non-sterile invasive devices represents a high-risk situation where harm has not yet been documented.
Plain-English summary
Merit Medical Systems, Inc. is recalling Fountain microcatheter and infusion system devices (model references IS4-135-30 and IS4-90-10) because the sterility of these devices cannot be guaranteed. These are prescription-only medical devices used in clinical procedures.
The recall affects devices distributed worldwide. In the United States, distribution included the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Utah, and Wisconsin. Internationally, devices were distributed to Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, the Netherlands, and Switzerland. Affected lots are H2765720 (IS4-135-30) and H2765603 (IS4-90-10).
Healthcare facilities and medical professionals should contact Merit Medical Systems regarding return or replacement instructions. Patients who have received these devices should speak with their healthcare provider about the recall and any necessary follow-up care.
The recalled product
- Product
- Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 3
Distribution
Part of a larger recall action
This product is one of 3 recalled by Merit Medical Systems, Inc. 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 3 products in this recall →Related recalls
Same manufacturer · Merit Medical Systems, Inc.
See all →- ModerateMerit Medical Systems Recalls Scout MD Delivery Systems Due to Deployment Issues
FDA (Devices) · 2026-10-21
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- HighSplashwire hydrophilic guide wire pouches have unsealed portions
FDA (Devices) · 2026-06-24
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighMerit Medical Procedure Kits Recalled for Compromised Sterile Barrier
FDA (Devices) · 2016-11-30
- HighFDA Recalls Aspira Peritoneal Drainage Catheter Insertion Tray for Valve Failure
FDA (Devices) · 2023-06-21
- HighMerit Medical Recalls Pressure Monitoring Kits Due to Sterile Barrier Compromise
FDA (Devices) · 2016-11-30
- HighIntelliSystem Inflation Device from Merit Medical Recalled for Sterile Barrier Defect
FDA (Devices) · 2024-10-23
- HighAspira Pleural Drainage Catheter Insertion Tray recalled due to valve failure
FDA (Devices) · 2023-06-21
- HighAspira Peritoneal Drainage Catheter Insertion Tray Valve Malfunction Recall
FDA (Devices) · 2023-06-21