Lower riskMedical device recall · FDA · Published February 11, 2019
Smith Medical JELCO Hypoderm: Incorrect needle length/gage recall
Smith Medical recalls JELCO Hypodermic Needle-Pro EDGE Safety Device due to incorrect needle length and gage. This may cause improper injections or injuries during use.
“Smith Medical JELCO Hypoderm: Incorrect needle length/gage recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69020-smith-medical-jelco-hypoderm-incorrect-needle-length-gage-recall. Based on FDA recall #Z-1733-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1733-2019%22&limit=1).
Smiths Medical ASD, Inc. recalled Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Devices due to incorrect needle length and gauge, the FDA said on Feb. 11, 2019. The voluntary Class II recall affects 96,000 units distributed in the U.S.
The devices have incorrect needle length and gauge, according to the FDA. The product is a disposable, single-use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe.
Context
GovInfoNow's records show Smiths Medical ASD, Inc. has had 73 other recalls on record since June 5, 2017. Other recent recalls include the Smiths Medical CADD Solis VIP Infusion Pump Recall for potential thermal damage (April 10, 2025), the Smiths Medical CADD-Solis VIP Infusion Pump Recall for false alarm risk (April 10, 2025), and the Smiths Medical CADD Solis HSPCA Pump recall for wireless connection alarms risk (April 10, 2025). Other recent recalls of similar products include the DeRoyal Myocardial Probe Recall for incorrect needle size hazard (Aug. 20, 2026), the Braun Medical Spinal Needle Kits Recall for potential quality issues with bupivacaine (May 6, 2026), and the Medline Surgical Packs Recall for calibration issues that may affect sterility (Jan. 7, 2026).
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.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 19 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution - AZ, CA, FL, GA, IL, IN, MA, MN, MO, MS, NJ, NY, PA, RI, SC, TN, TX, VA, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Georgia, Illinois, Indiana, Massachusetts, Minnesota, Mississippi, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.