FDA recall, , Moderate risk
Merit Medical Systems Scout MD Delivery System
The Scout MD Delivery System may have difficulty deploying, which could prevent the reflector from functioning.
Summary by Recall Canary from the FDA notice
What happened
Merit Medical Systems, Inc. recalled the Scout MD Delivery System, REF MDS05A-01, MDS05C-01, MDS10C-01, because the implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use. The FDA added the recall to its Enforcement Report on October 15, 2026, and the company began the recall on August 27, 2026. The product was distributed in Arizona, California, Florida, Indiana, Louisiana, Nevada and Rhode Island.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the Scout MD Surgical Guidance System, Rx Only, Sterile-EO
- UDI-DI
- 00884450392850
- 00884450392874
- 00884450392911
- Lot code
- H3515477
- H3507786
- H3507794
Recall details
- Company began the recall
- Sold in
US: Arizona, California, Florida, Indiana, Louisiana, Nevada, Rhode Island OUS: None
- Company
- Merit Medical Systems, Inc.
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99901
- Recall number
- Z-0187-2027
All recalls from Merit Medical Systems, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
