The Recall Desk
SevereFDA (Devices)·Z-1798-2021·Announced 2021-06-16

Jelco Insulin Syringe Graduation Markings Recalled for Skew Defect

Smiths Medical recalls 1,432,200 Jelco insulin syringes with skewed graduation markings that could lead to incorrect dosing. Specific lot numbers are affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This FDA Class I recall requires a minimum severity score of 4. Although no illnesses or injuries have been reported, the defect—skewed graduation markings that could lead to incorrect insulin dosing—poses a significant risk of harm to diabetic patients dependent on accurate dose measurement.

Plain-English summary

Smiths Medical ASD Inc. is recalling 1,432,200 units of Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes due to a manufacturing defect. The recall affects specific lot numbers of two models: 1.0 mL 28G x 1/2" (REF 4428-1) and 1.0 mL 29G x 1/2" (REF 4429-1).

The graduation markings on the syringe barrel are skewed approximately 20 degrees upward in affected units. These markings are critical for accurate insulin dosing; the skew may cause users to misread the intended dose and administer an incorrect amount of insulin.

The affected syringes were distributed worldwide, including throughout the United States, United Kingdom, and Spain. Specific affected lot numbers are identified in the FDA recall notice (Z-1798-2021).

Patients and healthcare providers should immediately discontinue use of recalled syringes. Anyone currently using a recalled syringe should consult their healthcare provider about alternative insulin delivery methods.

The recalled product

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
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Insulin Syringe
Hazard
Affected units
1,432,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 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

Distributed nationwide across the United States.

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