Reported Oct 23, 2024 · Ongoing
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- MONARCH Inflation Device
- REF
IN2430/BIN2530/BIN2130/B
- Lot codes and dates
- REF/UDI-DI/Lot(Expiration)IN2430/B/00884450298053/H2918428(4/22/2027). IN2530/B/00884450298060/H2918429(4/22/2027), H2925194(4/22/2027), H2929405(4/29/2027), H2934699(5/5/2027), H2937986(5/12/2027), H2943479(5/26/2027), H2978085(6/3/2027), H2982496(6/10/2027). IN2130/B/00884450298022/H2918427(4/22/2027), H2925193(4/22/2027), H2929404(4/29/2027), H2934698(5/5/2027), H2937984(5/12/2027), H2943477(6/3/2027), H2972585(5/26/2027), H2982494(6/10/2027)
- Amount recalled
- 12,910
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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