CLASS II Device recall · Reported 10 Nov 2021 · FDA Enforcement Report
Aspiration Syringe Kit recalled by Microvention
Microvention is recalling Aspiration Syringe Kit, distributed nationwide in the US. The recall was initiated on 20 Oct 2021 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-0202-2022
- FDA event ID
- 88892
- Recalling firm
- Microvention, Aliso Viejo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Oct 2021
- FDA classified
- 4 Nov 2021
- Reported
- 10 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 20 Oct 2021 | Recall initiated by company | |
| 4 Nov 2021 | Classified by FDA | +15 days |
| 10 Nov 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
Product as listed by the FDA
Aspiration Syringe Kit, REF: MVSK60
Where it was distributed
US Nationwide distribution in the states of AL, NY, NV.
Questions about this recall
Why was it recalled?
Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
Which lots are affected?
Lot: H2146461; UDI: (01)00816777025906(11)210727(17)240430(10)H2146461
Where was it sold?
US Nationwide distribution in the states of AL, NY, NV.
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.
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