Smith Medical JELCO Hypoderm: Incorrect needle length/gage recall

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Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Smith Medical is recalling its JELCO Hypodermic Needle-Pro EDGE Safety Device because it has incorrect needle length and gage. This could lead to improper injections or injuries if used.

Why it’s dangerous

The device has incorrect needle length and gage, which may cause improper injections or injuries during use. This could lead to complications if the device is not used correctly.

Who’s affected

Healthcare professionals and patients using this device for injections or aspirations. Those with specific needle length or gage needs are most at risk.

How to tell if you have this one

Look for the product name 'JELCO Hypodermic Needle-Pro EDGE Safety Device' with item # 402010 and lot # 3707576.

Brand
Smith Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the item number (402010) and lot number (3707576) on the device packaging.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The recall states the device has incorrect needle length and gage, which may cause improper injections or injuries. It is not safe to use as is.

How can I tell if I have the recalled product?

Look for the product name 'JELCO Hypodermic Needle-Pro EDGE Safety Device' with item # 402010 and lot # 3707576.

What should I do if I have the recalled device?

The recall does not specify a remedy, so check with Smith Medical for further instructions.

Take action

Contact Smith Medical

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

✉️ Open in email

Subject: Recall Z-1733-2019 — Smith Medical Smith Medical

Hello,

I own a Smith Medical that is covered by recall Z-1733-2019 from Smith Medical.

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-1733-2019 (February 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1733-2019 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.

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