CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
Scout MD recalled by Merit Medical Systems
Merit Medical Systems is recalling Scout MD, distributed in 7 states. The recall was initiated on 27 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0187-2027
- FDA event ID
- 99901
- Recalling firm
- Merit Medical Systems, South Jordan, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Aug 2026
- FDA classified
- 15 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 27 Aug 2026 | Recall initiated by company | |
| 15 Oct 2026 | Classified by FDA | +49 days |
| 21 Oct 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
Product as listed by the FDA
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
Where it was distributed
US: AZ, CA, FL, IN, LA, NV, RI OUS: None
Questions about this recall
Why was it recalled?
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
Which lots are affected?
MDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911
Where was it sold?
US: AZ, CA, FL, IN, LA, NV, RI OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Medline surgical convenience kits labeled as: EAR recalled | Medline Industries | Packaging Defects | Nationwide |
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