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

Lot, batch or date codesa. 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
Quantity recalled14,102 cases (6,340,900 units)

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-2037-2024
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

Timeline

4 Mar 2024Recall initiated by company
7 Jun 2024Classified by FDA+95 days
19 Jun 2024Published 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 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

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.

Nationwide

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 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

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 94518
ReportedClassRecallCompanyReasonWhere
CLASS IIINeomed* Pharmacy Syringes - Nonsterile (Non ENFit) recalledAvanos MedicalOtherNationwide
CLASS IIINeomed* Pharmacy Syringes - Nonsterile (Non ENFit) recalledAvanos MedicalOtherNationwide

More recalls from Avanos Medical

All 57

Other Syringes & Needles recalls

All 1,060