The Recall Desk
ModerateFDA (Devices)·Z-2035-2024·Announced 2024-06-19

NEOMED Pharmacy Syringes recalled due to missing expiration dates

Avanos Medical is recalling NEOMED Pharmacy Syringes because expiration dates were not printed on the outer shipping labels. Approximately 37,476 cases of various syringe sizes were distributed worldwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall involving a labeling defect (missing expiration dates on shipping labels). No illnesses or injuries have been reported. The hazard is that expired syringes could be distributed, which is a quality and safety concern but without documented harm.

Plain-English summary

Avanos Medical, Inc. is recalling NEOMED Pharmacy Syringes—Nonsterile (Non ENFit) in multiple sizes: 0.5mL, 1mL, 3mL, 6mL, 12mL, 20mL, 35mL, and 60mL. The recall affects approximately 37,476 cases (16,704,600 individual units). The syringes were shipped without expiration dates printed on the outer shipping labels, allowing expired products to be distributed to customers.

Without expiration dates visible on the shipping labels, it is difficult for distributors and facilities to identify which syringes have expired. This creates a risk that expired syringes may reach and be used by healthcare facilities and patients.

The recalled syringes have been distributed worldwide, including throughout the United States, Australia, New Zealand, Canada, Switzerland, the Netherlands, and Singapore. Customers who received these syringes should verify expiration information on the product and contact Avanos Medical or their supplier for guidance on return or replacement of any expired units.

The recalled product

Product
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d
Manufacturer
Avanos Medical, Inc.
Hazard
  • expired-product
  • labeling-defect

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 (9)

  • a. UDIDI 00350770002798
  • all lot numbers
  • b. UDIDI 00350770002835
  • c. UDIDI 00350770002804
  • d. UDIDI 00350770002842
  • e. UDIDI 00350770002859
  • f. UDIDI 00350770002811
  • g. UDIDI 00350770002866
  • h. UDIDI 00350770002828

Distribution

Distributed nationwide across the United States.