Apellis Pharmaceuticals, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2653-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 22, 2023

Date Posted: October 11, 2023

Recall Number: Z-2653-2023

Event ID: 92926

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

Status: Ongoing

Product Quantity: 61,943 units

Code Information:

UDI-DI: 00860008043672 Kit Lots: 223186 230036 230056 230236 230316 230326 230336 230406 231926 231946 231956 231986

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated