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Medical device recall · FDA · Published September 1, 2017

Aaren Scientific Inc. recalls AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on

Aaren Scientific recalls AERO IOL Injection System with incorrect storage temperature label. This may affect product sterility if stored improperly. Contact for details.

🇺🇸 FDA recall #Z-0071-2018Medical deviceAaren Scientific ›
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Contact the company & request your remedy

Recalling firmAaren Scientific Inc.1040 S Vintage Ave Ste A, N/A · Ontario, CA 91761-3631
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Aaren Scientific is recalling AERO IOL Injection System products due to an incorrect storage temperature label on the packaging. This could lead to potential sterility issues if the product is stored at the wrong temperature. Read more at govinfonow.com/recall/73081-aaren-scientific-aero-iol-injection-system-recall-incorrect-storage-temperature.

Source Summary by GovInfoNow · govinfonow.com/recall/73081-aaren-scientific-aero-iol-injection-system-recall-incorrect-storage-temperature · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0071-2018

Cite this page

“Aaren Scientific AERO IOL Injection System Recall: Incorrect Storage Temperature Label.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73081-aaren-scientific-aero-iol-injection-system-recall-incorrect-storage-temperature. Based on FDA recall #Z-0071-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0071-2018%22&limit=1).

Why it’s dangerous

The label incorrectly states the recommended storage temperature, which could lead to improper storage conditions. If the product is stored at the wrong temperature, it might not remain sterile, potentially causing infections or other complications during medical procedures.

Who’s affected

Users of the AERO IOL Injection System, particularly those who store the product at temperatures other than the correct one. The risk is low as the hazard is related to labeling rather than direct harm.

How to tell if you have this one

Check for the product name 'AERO IOL Injection System' with part number 003500-0025-282. The lot numbers include 160204 through 170120 with expiration dates up to 12/31/2018.

  • Brand
    Aaren Scientific
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Storage Conditions

    Ensure the product is stored at the correct temperature as per the actual manufacturer guidelines, not the label.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to an incorrect storage temperature label on the packaging, which could lead to improper storage and potential sterility issues.

What should I do if I have this product?

Check if you have the AERO IOL Injection System with part number 003500-0025-282 and lot numbers from 160204 to 170120. Ensure it is stored at the correct temperature.

Is there a fix for this issue?

The official notice does not mention a specific fix or remedy for this recall.

Take action

Contact Aaren Scientific

We’ve drafted a message you can send Aaren Scientific to request your refund or repair — edit it as you like.

Subject: Recall Z-0071-2018 — Aaren Scientific Aaren Scientific

Hello,

I own a Aaren Scientific that is covered by recall Z-0071-2018 from Aaren Scientific.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0071-2018 (September 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0071-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA