CLASS II ONGOING Device recall · Reported 23 Oct 2024 · FDA Enforcement Report
StabiliT Touch Syringe recalled by Merit Medical Systems
Merit Medical Systems is recalling StabiliT Touch Syringe, distributed nationwide in the US. The recall was initiated on 19 Aug 2024 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-0073-2025
- FDA event ID
- 95343
- Recalling firm
- Merit Medical Systems, South Jordan, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Aug 2024
- FDA classified
- 11 Oct 2024
- Reported
- 23 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Syringes & Needles
Timeline
| 19 Aug 2024 | Recall initiated by company | |
| 11 Oct 2024 | Classified by FDA | +53 days |
| 23 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
StabiliT TOUCH Syringe, REF: IN8VCF/B
Where it was distributed
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Is StabiliT Touch Syringe recalled?
Yes. Merit Medical Systems recalled StabiliT Touch Syringe on 19 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-0073-2025.
Why was it 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.
Which lots are affected?
REF/UDI-DI/Lot(Expiration): IN8VCF/B/00884450662144/H2918440(5/31/2027), H2938015(7/26/2027).
Where was it sold?
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.
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 21 Sep 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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