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 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;

Quantity recalled37,476 cases (16,704,600 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-2035-2024
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 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;

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 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;

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

This 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
19 Jun 2024	CLASS III	Neomed* Pharmacy Syringes - Nonsterile (Non ENFit) recalled	Avanos Medical	Other	Nationwide
19 Jun 2024	CLASS III	Neomed* Pharmacy Syringes - Nonsterile (Non ENFit) recalled	Avanos Medical	Other	Nationwide

More recalls from Avanos Medical

All 57

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Device	CLASS II	MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit PUSH OTW recalled	Avanos Medical	Sterility	Nationwide
17 Jun 2026Device	CLASS II	MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit recalled	Avanos Medical	Sterility	Nationwide
17 Jun 2026Device	CLASS II	MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit PULL recalled	Avanos Medical	Sterility	Nationwide
17 Jun 2026Device	CLASS II	MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit recalled	Avanos Medical	Sterility	Nationwide
17 Jun 2026Device	CLASS II	Corflo Safety PEG Kit with ENFit Connector recalled by Avanos Medical	Avanos Medical	Sterility	Nationwide

Other Syringes & Needles recalls

All 1,060

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS I	BD Needle Kit for Powered Driver recalled by Bard Access Systems	Bard Access Systems	Other	32 states
19 Aug 2026Device	CLASS II	Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled	Galt Medical	Other	Nationwide
15 Jul 2026Device	CLASS II	Geneva Brachytherapy Applicator recalled by Elekta	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
8 Jul 2026Device	CLASS II	Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled	BD Switzerland Sarl	Other	IL