RecallRadar

FDA Device recall Z-0187-2027

Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance…

On 2026-10-21 the FDA classified a Class II recall of Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance… by Merit Medical Systems, citing the implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0187-2027
ClassificationClass II
Statusongoing
Initiated2026-08-27
Published2026-10-21
Last updated2026-10-27 05:30 UTC
CompanyMerit Medical Systems
DistributionAZ, CA, FL, IN, LA, NV, RI

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

Reason

The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.

Identifiers

code_infoMDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.

Other recalls by Merit Medical Systems

All Merit Medical Systems recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0187-2027%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.