NEOMED nonsterile pharmacy syringes recalled for missing expiration dates on labels
Avanos Medical recalls NEOMED nonsterile pharmacy syringes because expiration dates were not printed on outer shipping labels, resulting in expired products being distributed.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 error where expiration dates were not printed on shipping labels. No illnesses or injuries have been reported, and the hazard remains theoretical absent evidence of actual harm from use of expired products.
Plain-English summary
Avanos Medical, Inc. is recalling NEOMED* Pharmacy Syringes (Nonsterile, Non ENFit) in multiple sizes: 0.5mL, 1mL, 2mL, 3mL, 6mL, 12mL, 20mL, 35mL, and 60mL. The recall involves approximately 27,664 cases, representing 12,155,300 individual units.
The recall was initiated because expiration dates were not printed on the outer shipping labels. This resulted in expired syringes being distributed to customers.
The affected products have been distributed worldwide, including throughout the United States and to customers in Australia, New Zealand, Canada, Switzerland, the Netherlands, and Singapore.
The recalled product
- Product
- NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d.…
- Manufacturer
- Avanos Medical, Inc.
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 (20)
- a. UDIDI 00350770002958
- all lot numbers
- SAP Numbers 120000508
- 120001160
- b. UDIDI 00350770002996
- SAP Numbers 120000512
- 120001164
- c. UDIDI 00350770002965
- SAP Numbers 120000509
- 120001161
- d. UDIDI 00350770003009
- SAP Numbers 120000513
- 120001165
- e. UDIDI 00350770003016
- SAP Numbers 120000514
- 120001166
- f. UDIDI 00350770002972
- SAP Numbers 120000510
- 120001162
- g. UDIDI 00350770003023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Avanos Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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