Apellis Injection Kit 29g Injection Needle -single use intended to… — Class II medical device recall Z-2653-2023
Ongoing recall by Apellis Pharmaceuticals, Inc., reported 2023-10-11, distributed nationwide. 19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A c
| Recall number | Z-2653-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apellis Pharmaceuticals, Inc., Waltham, MA, United States |
| Recall initiated | 2023-08-22 |
| Classified | 2023-09-29 |
| Reported by FDA | 2023-10-11 |
| Distributed | Nationwide (US) |
| Quantity | 61,943 units |
| UPC / GTIN / UDI-DI | 00860008043672 |
| Lot numbers | 223186, 230036, 230056, 230236, 230316, 230326, 230336, 230406, 231926, 231946, 231956, 231986 |
| Model numbers | IVT-KIT-29G |
Product
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
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.