Reported Oct 23, 2024 · Ongoing
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
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?
- basixTOUCH Inflation Device
- REF
IN8130/JPCIN8152/CIN8302/CIN8352/CIN8802/CIN8130/CIN8130/C
- Lot codes and dates
- REF/UDI-DI/Lot(Expiration)IN8130/JPC/00884450621073/H2929530(4/29/2027). IN8152/C/00884450621301/H2925219(4/22/2027), H2929412(4/29/2027), H2938005(5/12/2027), H2938006(5/12/2027), H2943498(5/19/2027), H2943499(5/19/2027), H2972593(5/26/2027), H2972594(5/26/2027), H2978092(6/3/2027). IN8302/C/00884450621325/H2925221(4/22/2027). IN8352/C/00884450621349/H2934719(5/5/2027). IN8802/C/00884450621417/H2925222(4/22/2027), H2934720(5/12/2027), H2943517(5/19/2027), H2972598(5/26/2027). IN8130/C/00884450621059/H2925215(4/22/2027), H2929410(4/29/2027), H2934714(5/5/2027), H2937998(5/12/2027), H2938000(5/12/2027), H2943487(5/19/2027). IN8130/C/00884450621059/H2972590(5/26/2027), H2978089(6/3/2027), H2978090(6/3/2027), H2978091(6/3/2027), H2989571(6/17/2027)
- Amount recalled
- 16,439
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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