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Low RiskFDA Device
Medical Devices/Home Healthcare

Avanos Medical, Inc.: NEOMED Pharmacy Syringes Recalled Due to Missing Expiration Dates

Agency Publication Date: June 7, 2024
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Summary

Avanos Medical, Inc. is recalling approximately 79,242 cases (over 35 million units) of NEOMED Pharmacy Syringes, which are non-sterile oral syringes used for measuring and administering medications. These syringes were shipped without expiration dates printed on the outer shipping labels, which resulted in expired products being delivered to customers. The recall affects three distinct product lines: Amber, Blue, and Orange non-sterile syringes in various sizes ranging from 0.5mL to 60mL.

Risk

Using expired syringes may compromise the accuracy of medication dosing or the physical integrity of the device, as materials can degrade over time. While the risk is considered low, using an expired medical device could lead to improper treatment or minor health complications.

What You Should Do

  1. Check your inventory for NEOMED Pharmacy Syringes (Non-sterile, Non-ENFit) in Amber (BA-S product codes), Blue (BB-S product codes), or Orange (BC-S product codes) colors.
  2. Verify if your product is affected by checking for the specific Product Codes and UDIDI numbers: Amber (00350770002798 to 00350770002866), Blue (00350770002958 to 00350770003023), or Orange (00350770002873 to 00350770002941).
  3. Identify the specific SAP Numbers on Blue syringes (e.g., 120000508, 120001160) and Orange syringes (e.g., 120000488, 120001138) to confirm they are part of this recall.
  4. Immediately stop using any syringes identified as part of these affected lots and quarantine them to prevent further use.
  5. Contact your healthcare provider or Avanos Medical, Inc. at 1-888-463-6332 for further instructions on returning the products and obtaining replacements.
  6. For additional questions or to report a problem, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and contact manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: NEOMED Pharmacy Syringes - Nonsterile Amber (0.5mL, 1mL, 3mL, 6mL, 12mL, 20mL, 35mL, 60mL)
Model / REF:
BA-S05EO
BA-S12EO
BA-S1EO
BA-S20EO
BA-S35EO
BA-S3EO
BA-S60EO
BA-S6EO
UPC Codes:
00350770002798
00350770002835
00350770002804
00350770002842
00350770002859
00350770002811
00350770002866
00350770002828
Lot Numbers:
all lot numbers
Product: NEOMED Pharmacy Syringes - Nonsterile Blue (0.5mL, 1mL, 3mL, 6mL, 12mL, 20mL, 35mL, 60mL)
Model / REF:
BB-S05EO
BB-S12EO
BB-S1EO
BB-S20EO
BB-S35EO
BB-S3EO
BB-S60EO
BB-S6EO
UPC Codes:
00350770002958
00350770002996
00350770002965
00350770003009
00350770003016
00350770002972
00350770003023
00350770002989
Lot Numbers:
all lot numbers
SAP 120000508
SAP 120001160
SAP 120000512
SAP 120001164
SAP 120000509
SAP 120001161
SAP 120000513
SAP 120001165
SAP 120000514
SAP 120001166
SAP 120000510
SAP 120001162
SAP 120000515
SAP 120001167
SAP 120000511
SAP 120001163
Product: NEOMED Pharmacy Syringes - Nonsterile Orange (0.5mL, 1mL, 3mL, 6mL, 12mL, 20mL, 35mL, 60mL)
Model / REF:
BC-S05EO
BC-S12EO
BC-S1EO
BC-S20EO
BC-S35EO
BC-S3EO
BC-S60EO
BC-S6EO
UPC Codes:
00350770002873
00350770002910
00350770002880
00350770002927
00350770002934
00350770002897
00350770002941
00350770002903
Lot Numbers:
all lot numbers
SAP 120000488
SAP 120001138
SAP 120000492
SAP 120001142
SAP 120000489
SAP 120001139
SAP 120000493
SAP 120001143
SAP 120000494
SAP 120001144
SAP 120000490
SAP 120001140
SAP 120000495
SAP 120001145
SAP 120000491
SAP 120001141

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94518
Status: Active
Manufacturer: Avanos Medical, Inc.
Sold By: Avanos Medical, Inc.; Pharmacy distributors; Medical supply distributors
Manufactured In: United States
Units Affected: 3 products (37,476 cases (16,704,600 units); 27,664 cases (12,155,300 units); 14,102 cases (6,340,900 units))
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.