NEOMED Oral Syringes Recalled Over Missing Expiration Dates on Labels
Avanos Medical is recalling NEOMED oral syringes because expiration dates were not printed on outer shipping labels, allowing expired units to reach customers.
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: Class III recall due to a labeling defect where expiration dates were not printed on outer shipping labels, resulting in the distribution of expired nonsterile syringes.
Plain-English summary
Avanos Medical, Inc. is recalling NEOMED Pharmacy Syringes—nonsterile, non-ENFit oral syringes available in sizes ranging from 0.5mL to 60mL. Approximately 6.3 million units across 14,102 cases are included in this recall.
The expiration date was not printed on the outer shipping labels for these products. This labeling omission allowed expired syringes to be distributed to customers without clear indication of their expiration status on the shipping containers.
The affected products were distributed worldwide, including throughout the United States and to Australia, New Zealand, Canada, Switzerland, the Netherlands, and Singapore. Affected customers should consult the recall notification for specific product codes, UDI-DI numbers, and lot information.
For questions regarding the recall or to confirm whether specific products are affected, customers should contact Avanos Medical, Inc.
The recalled product
- Product
- NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, Product Code BC-S12EO; c. 1mL Oral Syringe Orange NonSterile, Product Code BC-S1EO;
- Manufacturer
- Avanos Medical, Inc.
- Category
- Medical Device — Oral Syringes
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 00350770002873
- all lot numbers
- SAP Numbers 120000488
- 120001138
- b. UDIDI 00350770002910
- SAP Numbers 120000492
- 120001142
- c. UDIDI 00350770002880
- SAP Numbers 120000489
- 120001139
- d. UDIDI 00350770002927
- SAP Numbers 120000493
- 120001143
- e. UDIDI 00350770002934
- SAP Numbers 120000494
- 120001144
- f. UDIDI 00350770002897
- SAP Numbers 120000490
- 120001140
- g. UDIDI 00350770002941
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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