Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-1798-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1

Product Classification:

Class I

Date Initiated: May 17, 2021

Date Posted: June 16, 2021

Recall Number: Z-1798-2021

Event ID: 87945

Reason for Recall:

Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.

Status: Terminated

Product Quantity: 1,432,200 units

Code Information:

a) REF 4428-1, Lot Numbers: 4046543 and 4062235 b) REF 4429-1, Lot Numbers: 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238, 4062242, 4014096

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of UK, Spain.

Voluntary or Mandated:

Voluntary: Firm initiated