FDA Medical Device Recalls (openFDA)
Avanos Medical, Inc.: 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; d. 20mL Oral Syringe Orange NonSterile, Product Code BC-S20EO; e. 35mL Oral Syringe Orange NonSterile, Product Code BC-S35EO; f. 3mL Oral Syringe Orange NonSterile, Product Code BC-S3EO; g. 60mL Oral Syringe Orange NonSterile, Product Code BC-S60EO; h. 6mL Oral Syringe Orange NonSterile, Product Code BC-S6EO
- Recall number
- Z-2037-2024
- Recalling firm
- Avanos Medical, Inc.
- 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; d. 20mL Oral Syringe Orange NonSterile, Product Code BC-S20EO; e. 35mL Oral Syringe Orange NonSterile, Product Code BC-S35EO; f. 3mL Oral Syringe Orange NonSterile, Product Code BC-S3EO; g. 60mL Oral Syringe Orange NonSterile, Product Code BC-S60EO; h. 6mL Oral Syringe Orange NonSterile, Product Code BC-S6EO
- Status
- Open, Classified
- Initiated
- 2024-03-04
- Posted
- 2024-06-07
- Terminated
- not on file
- Reason
- The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
- Root cause
- Under Investigation by firm
- Action
- Avanos notified consignees via email or overnight FedEx on or about 03/04/2024. Consignees were instructed to locate affected product in their inventories by comparing the case packaging as demonstrated in the letters, and destroying it. An acknowledgment form was provided in order for them to record their inventory, and confirm destruction, to be returned to fieldactioncare@avanos.com. Replacement with unaffected Avanos NeoMed* Pharmacy Syringes Nonsterile (Non ENFit) will be provided to end users who report affected inventory. Distributors are asked to identify their affected customers and provide notification to them, as well as report theirs and their customers inventory to Avanos via the acknowledgment form.
- Quantity
- 14,102 cases (6,340,900 units)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.
- Lot, serial or model codes
- a. UDIDI 00350770002873, all lot numbers, SAP Numbers 120000488, 120001138; b. UDIDI 00350770002910, all lot numbers, SAP Numbers 120000492, 120001142; c. UDIDI 00350770002880, all lot numbers, SAP Numbers 120000489, 120001139; d. UDIDI 00350770002927, all lot numbers, SAP Numbers 120000493, 120001143; e. UDIDI 00350770002934, all lot numbers, SAP Numbers 120000494, 120001144; f. UDIDI 00350770002897, all lot numbers, SAP Numbers 120000490, 120001140; g. UDIDI 00350770002941, all lot numbers, SAP Numbers 120000495, 120001145; h. UDIDI 00350770002903, all lot numbers, SAP Numbers 120000491, 120001141
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYX
- Firm FEI
- 3011270181
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06