CLASS II ONGOING Device recall · Reported 20 Aug 2025 · FDA Enforcement Report
Custom Tubing Kit recalled by Merit Medical Systems
Merit Medical Systems is recalling Custom Tubing Kit, distributed nationwide in the US. The recall was initiated on 5 Jun 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-2294-2025
- FDA event ID
- 97151
- Recalling firm
- Merit Medical Systems, South Jordan, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Jun 2025
- FDA classified
- 12 Aug 2025
- Reported
- 20 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Jun 2025 | Recall initiated by company | |
| 12 Aug 2025 | Classified by FDA | +68 days |
| 20 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
Product as listed by the FDA
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Where it was distributed
US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA.
Nationwide AlabamaArkansasArizonaCaliforniaConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMaineMichiganMinnesotaMontanaNorth CarolinaNorth Dakota
Questions about this recall
Why was it recalled?
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
Which lots are affected?
REF/UDI-DI/Lot(Expiration): K04-00417/00884450046630/I3114667(12/10/2027), I3147550(1/28/2028); K04-00963/00884450046760/H3117053(12/14/2027), H3138590(1/20/2028), H3154108(2/10/2028), H3154786(2/10/2028), H3162244(2/19/2028), H3166789(3/2/2028), H3173526(3/23/2028); K04-01029/00884450148938/H3117059(12/17/2027), H3154112(2/10/2028), H3159017(2/19/2028), H3166777(3/9/2028), H3181994(4/1/2028);
Where was it sold?
US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA.
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
3 other products · FDA event 97151This product is part of a recall event; the main page for the event is Custom Manifold Kit recalled by Merit Medical Systems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Custom Manifold Kit recalled by Merit Medical Systems | Merit Medical Systems | Other | Nationwide | |
| CLASS II | High Pressure Tubing recalled by Merit Medical Systems | Merit Medical Systems | Other | Nationwide | |
| CLASS II | Custom Waste Management Kit recalled by Merit Medical Systems | Merit Medical Systems | Other | Nationwide |
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