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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Apellis Pharmaceuticals, Inc.: Apellis Injection Kits Recalled for Filter Needle Structural Variations

Agency Publication Date: September 29, 2023
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Summary

Apellis Pharmaceuticals has recalled approximately 61,943 Apellis Injection Kits (Reference IVT-KIT-29G) because the 19-gauge filter needles included in the kits may have structural variations or non-preferred characteristics. These structural issues have been associated with rare reports of retinal vasculitis, a serious condition involving inflammation of the eye's blood vessels, although a direct causal link has not yet been confirmed. The kits were distributed nationwide across the United States. Consumers and healthcare providers should immediately check their supplies for the specific lot numbers affected by this recall.

Risk

Structural defects in the filter needles could potentially lead to retinal vasculitis during medical procedures, which may cause eye inflammation and threaten a patient's vision.

What You Should Do

  1. Identify if you have the affected product by looking for 'Apellis Injection Kit 29g Injection Needle' with Reference number IVT-KIT-29G and UDI-DI 00860008043672 on the packaging.
  2. Check the kit lot number on the exterior label to see if it matches any of the following: 223186, 230036, 230056, 230236, 230316, 230326, 230336, 230406, 231926, 231946, 231956, or 231986.
  3. If you are a healthcare provider, stop using kits from these affected lots immediately.
  4. Contact your healthcare provider or Apellis Pharmaceuticals for further instructions regarding the disposal or return of these kits and to obtain information about replacements.
  5. Patients who have recently undergone an injection using these kits and experience vision changes or eye pain should contact their healthcare provider immediately.
  6. For additional questions or to report issues, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer contact for instructions.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Apellis Injection Kit 29g Injection Needle
Model / REF:
IVT-KIT-29G
Z-2653-2023
UPC Codes:
00860008043672
Lot Numbers:
223186
230036
230056
230236
230316
230326
230336
230406
231926
231946
231956
231986

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92926
Status: Active
Manufacturer: Apellis Pharmaceuticals, Inc.
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 61,943 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.