Z-1798-2021Class I

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

Name: Z-1798-2021 JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b)...
Creator: Smiths Medical ASD Inc.
Published: 2021-05-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-05-17 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of 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 on 2021-05-17. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1798-2021
Classification: Class I
Status: Terminated
Initiated: 2021-05-17
Posted: 2021-06-10
Terminated: 2023-10-11
Recalling firm: Abbott Medical
Product: 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 code: MEG Syringe, Antistick
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall on May 17, 2021 by email. The firm is seeking the removal of the product down to the consumer level. For assistance ease contact Novasyte using the Email: [email protected] The firm later realized they failed to include lot #40140906 for model #4429-1 and issued a second letter which was dated 5/27/2021 to customers involved in the first notification where this lot was excluded in the letter, as well as to new consignees who received the affected lot.
Quantity in commerce: 1,432,200 units
Distribution: Worldwide distribution - US Nationwide and the countries of UK, Spain.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1798-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1798-2021	Class I	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-10

Product code MEG

K063755Class IIPortex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. / cleared 2007-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)