Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Apellis Injection Kit 29g Injection Needle -single use intended to Recalled by Apellis Pharmaceuticals, Inc. Due to 19-gauge x 1" inch filter needles showed appearances...

Date: August 22, 2023
Company: Apellis Pharmaceuticals, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Apellis Pharmaceuticals, Inc. directly.

Affected Products

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

Quantity: 61,943 units

Why Was This 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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Apellis Pharmaceuticals, Inc.

Apellis Pharmaceuticals, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report