FDA Device recall Z-2035-2024
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA…
- FDA Device
- Class III
- ongoing
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class III recall of NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA… by Avanos Medical, citing the expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2035-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-03-04 |
| Published | 2024-06-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Avanos Medical |
| Distribution | US |
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.
Identifiers
| code_info | a. UDIDI 00350770002798, all lot numbers; b. UDIDI 00350770002835, all lot numbers; c. UDIDI 00350770002804, all lot…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; |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2035-2024%22
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