Recall archive / FDA device enforcement
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSt... — FDA record Z-2035-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 4, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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. 20mL Oral Syringe Amber NonSterile, Product Code BA-S20EO; e. 35mL Oral Syringe Amber NonSterile, Product Code BA-S35EO; f. 3mL Oral Syringe Amber NonSterile, Product Code BA-S3EO; g. 60mL Oral Syringe Amber NonSterile, Product Code BA-S60EO; h. 6mL Oral Syringe Amber NonSterile, Product Code BA-S6EO;
- Reason
- The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
- Classification
- Class III
- Recalling firm
- Avanos Medical, Inc.
- Quantity
- 37,476 cases (16,704,600 units)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2035-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a. UDIDI 00350770002798, all lot numbers; b. UDIDI 00350770002835, all lot numbers; c. UDIDI 00350770002804, all lot numbers; d. UDIDI 00350770002842, all lot numbers; e. UDIDI 00350770002859, all lot numbers; f. UDIDI 00350770002811, all lot numbers; g. UDIDI 00350770002866, all lot numbers; h. UDIDI 00350770002828, all lot numbers; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 19, 2024
- Recall initiation date
- Mar 4, 2024
- Center classification date
- Jun 7, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.