Z-0187-2027

Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with...

Name: Z-0187-2027 Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with...
Creator: Merit Medical Systems, Inc.
Published: 2026-08-27
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2026-08-27 / Open, Classified

FDA source

Recall record

Recall number: Z-0187-2027
Status: Open, Classified
Initiated: 2026-08-27
Posted: 2026-10-15
Recalling firm: Merit Medical Systems, Inc.
Product: 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
Product code: NEU Marker, Radiographic, Implantable
Reason for recall: The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
FDA root cause: Process control
Action: On August 27, 2026, Merit Medical issued a Urgent Medical Device Recall Notice to affected consignees via FedEx. Merit ask consignees to take the following actions: 1. Immediately determine if any of the devices identified in the attached Customer ResponseForm (CRF) are within your facility. 2. Immediately discontinue the use of the affected lots of the SCOUT MD Delivery System. 3. Ensure that applicable personnel within your organization are made aware of this recall. 4. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. 5. Please fill out, scan and email the completed CRF to Customer Service at [email protected] within 7 business days. All affected products shipped to you must be accounted for on the CRF. 6. Immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF.
Distribution: US: AZ, CA, FL, IN, LA, NV, RI OUS: None
Product codes and lots: MDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911

Product code NEU

K252892Class IISCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc. / cleared 2025-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-10-21. View this recall on fda.gov (opens on fda.gov)