CLASS III ONGOING Device recall · Reported 19 Jun 2024 · FDA Enforcement Report
Neomed* Pharmacy Syringes - Nonsterile (Non ENFit) recalled
Avanos Medical is recalling Neomed* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a, distributed nationwide in the US. The recall was initiated on 4 Mar 2024 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2036-2024
- FDA event ID
- 94518
- Recalling firm
- Avanos Medical, Alpharetta, GA
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 4 Mar 2024
- FDA classified
- 7 Jun 2024
- Reported
- 19 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 4 Mar 2024 | Recall initiated by company | |
| 7 Jun 2024 | Classified by FDA | +95 days |
| 19 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Product as listed by the FDA
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 20mL Oral Syringe Blue NonSterile, Product Code BB-S20EO; e. 35mL Oral Syringe Blue NonSterile, Product Code BB-S35EO; f. 3mL Oral Syringe Blue NonSterile, Product Code BB-S3EO; g. 60mL Oral Syringe Blue NonSterile, Product Code BB-S60EO; h. 6mL Oral Syringe Blue NonSterile, Product Code BB-S6EO;
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.
Questions about this recall
Why was it recalled?
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Which lots are affected?
a. UDIDI 00350770002958, all lot numbers, SAP Numbers 120000508, 120001160; b. UDIDI 00350770002996, all lot numbers, SAP Numbers 120000512, 120001164; c. UDIDI 00350770002965, all lot numbers, SAP Numbers 120000509, 120001161; d. UDIDI 00350770003009, all lot numbers, SAP Numbers 120000513, 120001165; e. UDIDI 00350770003016, all lot numbers, SAP Numbers 120000514, 120001166; f. UDIDI 00350770002972, all lot numbers, SAP Numbers 120000510, 120001162; g. UDIDI 00350770003023, all lot numbers, SAP Numbers120000515, 120001167; h. UDIDI 00350770002989, all lot numbers SAP Numbers 120000511, 120001163
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 94518This product is part of a recall event; the main page for the event is Neomed* Pharmacy Syringes - Nonsterile (Non ENFit) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Neomed* Pharmacy Syringes - Nonsterile (Non ENFit) recalled | Avanos Medical | Other | Nationwide | |
| CLASS III | Neomed* Pharmacy Syringes - Nonsterile (Non ENFit) recalled | Avanos Medical | Other | Nationwide |
More recalls from Avanos Medical
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|---|---|---|---|---|---|
| Device | CLASS II | MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit PUSH OTW recalled | Avanos Medical | Sterility | Nationwide |
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| Device | CLASS II | MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit recalled | Avanos Medical | Sterility | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
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| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |