CLASS II ONGOING Device recall · Reported 17 Jul 2024 · FDA Enforcement Report
Synergetics I Pack Injection Kit recalled by MICROspecialties
MICROspecialties is recalling Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection, distributed in Missouri. The recall was initiated on 5 Jun 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-2336-2024
- FDA event ID
- 94794
- Recalling firm
- MICROspecialties, Middletown, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Jun 2024
- FDA classified
- 11 Jul 2024
- Reported
- 17 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 5 Jun 2024 | Recall initiated by company | |
| 11 Jul 2024 | Classified by FDA | +36 days |
| 17 Jul 2024 | 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
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
Where it was distributed
MO
Questions about this recall
Is Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection recalled?
Yes. MICROspecialties recalled Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection on 5 Jun 2024. The recall is Class II and its status is Ongoing. Recall number Z-2336-2024.
Why was it recalled?
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Which lots are affected?
UDI: 10841305101132 LOT: P62764970R
Where was it sold?
MO
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.
More recalls from MICROspecialties
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Synergetics I Pack Injection Kit- Tray for use recalled | MICROspecialties | Sterility | MO |
| Device | CLASS II | Synergetics I-Pack Injection Kit with Drape -For use recalled | MICROspecialties | Sterility | MO |
| Device | CLASS II | Synergetics I Pack Injection Kit Custom-Tray for use recalled | MICROspecialties | Sterility | MO |
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