Cardinal Health Monoject Needles: Sterility Risk in 14G 1-1/2" Needles

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Contact the company & request your remedy

Recalling firmCardinal Health 200, LLC15 Hampshire St Bldg 5, N/A · Mansfield, MA 02048-1113

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Cardinal Health is recalling 14-gauge 1-1/2-inch Monoject needles because a manufacturing defect might break the sterile seal. This could lead to infections if needles are used improperly.

Why it’s dangerous

A manufacturing defect in the cartridge component could compromise the sterility barrier. This means the needles might not be sterile, increasing infection risk during use.

Who’s affected

People who own or use these needles for medical injections are affected. Those with diabetes or other conditions requiring frequent injections are at higher risk.

How to tell if you have this one

Check for the item code 8881200011 on the needle packaging. Affected lot numbers are 904218, 904918, and 906329.

Brand
Cardinal Health
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Needle Packaging
Look for the item code 8881200011 and affected lot numbers 904218, 904918, or 906329.

✎ GovInfoNow

Questions people ask

Are these needles safe to use?

The needles may not be sterile due to a manufacturing defect, so they should not be used.

What should I do if I have these needles?

Check the lot number on the packaging. If it matches the affected numbers, stop using them immediately.

How can I get a replacement?

The recall record does not mention a replacement option.

Take action

Contact Cardinal Health

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

✉️ Open in email

Subject: Recall Z-2036-2019 — Cardinal Health Cardinal Health

Hello,

I own a Cardinal Health that is covered by recall Z-2036-2019 from Cardinal Health.

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-2036-2019 (April 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2036-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

Cardinal Health 200, LLC recalls Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011

Lower-risk recall