Smiths Medical ASD Inc.: Medical Device Recall in 2019 - (Recall #: Z-1733-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.

Product Classification:

Class II

Date Initiated: February 11, 2019

Date Posted: June 12, 2019

Recall Number: Z-1733-2019

Event ID: 82503

Reason for Recall:

Incorrect needle length and gage.

Status: Terminated

Product Quantity: 109000 (96,000 USA)

Code Information:

Item # 402010 Lot # 3707576

Distribution Pattern:

US Nationwide Distribution - AZ, CA, FL, GA, IL, IN, MA, MN, MO, MS, NJ, NY, PA, RI, SC, TN, TX, VA, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated