CLASS II ONGOING Device recall · Reported 28 Jan 2026 · FDA Enforcement Report
Merit Medical , Custom Manifold Kit recalled
Merit Medical Systems is recalling Merit Medical , Custom Manifold Kit, distributed nationwide in the US. The recall was initiated on 4 Dec 2025 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-1127-2026
- FDA event ID
- 98139
- Recalling firm
- Merit Medical Systems, South Jordan, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Dec 2025
- FDA classified
- 16 Jan 2026
- Reported
- 28 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Dec 2025 | Recall initiated by company | |
| 16 Jan 2026 | Classified by FDA | +43 days |
| 28 Jan 2026 | 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 device handle may detach from the syringe during procedure.
Product as listed by the FDA
Merit Medical , Custom Manifold Kit REF: K09-13203A
Where it was distributed
Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, 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, RI, SC, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Inflation device handle may detach from the syringe during procedure.
Which lots are affected?
K09-13203A: UDI: 00884450479964 /Lot: H2671718 H2681531 H2758436 H2792533 H2796074 H3046979 H3052442 H3147779 H3246149 H3254530 H3297407
Where was it sold?
Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, 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, RI, SC, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 98139This product is part of a recall event; the main page for the event is Allwell Inflation Device, for angiographic use recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Allwell Inflation Device, for angiographic use recalled | Merit Medical Systems | Other | Nationwide | |
| CLASS II | Merit Medical Inflation Device.basixCOMPAK.30 atm/bar recalled | Merit Medical Systems | Other | Nationwide | |
| CLASS II | Merit Medical , Custom Waste Management Kit Vascular Tray recalled | Merit Medical Systems | Other | Nationwide | |
| CLASS II | Merit Medical , Custom Inflation Kit recalled | Merit Medical Systems | Other | Nationwide | |
| CLASS II | Merit Medical , Custom Procedure Kit Reference Numbers recalled | Merit Medical Systems | Other | Nationwide | |
| CLASS II | Allwell Angioplasty Pack recalled by Merit Medical Systems | Merit Medical Systems | Other | Nationwide |
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