CLASS II ONGOING Device recall · Reported 11 Oct 2023 · FDA Enforcement Report
Apellis Injection Kit Injection Needle -single use intended recalled
Apellis Pharmaceuticals is recalling Apellis Injection Kit Injection Needle -single use intended to inject fluids into, or, distributed nationwide in the US. The recall was initiated on 22 Aug 2023 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-2653-2023
- FDA event ID
- 92926
- Recalling firm
- Apellis Pharmaceuticals, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Aug 2023
- FDA classified
- 29 Sep 2023
- Reported
- 11 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 22 Aug 2023 | Recall initiated by company | |
| 29 Sep 2023 | Classified by FDA | +38 days |
| 11 Oct 2023 | 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
19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis
Product as listed by the FDA
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Apellis Injection Kit Injection Needle -single use intended to inject fluids into, or recalled?
Yes. Apellis Pharmaceuticals recalled Apellis Injection Kit Injection Needle -single use intended to inject fluids into, or on 22 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-2653-2023.
Why was it recalled?
19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis
Which lots are affected?
UDI-DI: 00860008043672 Kit Lots: 223186 230036 230056 230236 230316 230326 230336 230406 231926 231946 231956 231986
Where was it sold?
US Nationwide distribution.
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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