CLASS II Device recall · Reported 6 Nov 2019 · FDA Enforcement Report

DEMO No Needle Corrugated Carton 20 U/D recalled

Valeritas is recalling DEMO No Needle Corrugated Carton 20 U/D, distributed nationwide in the US. The recall was initiated on 3 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (01)10385609021039(17)XXXXXX(10)XXXXXXXX Lot Number: DM218024

Quantity recalled852 devices

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-0198-2020
FDA event ID: 83386
Recalling firm: Valeritas, Marlborough, MA
Classification: Class II
Status: Terminated
Recall initiated: 3 Jul 2019
FDA classified: 26 Oct 2019
Reported: 6 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

3 Jul 2019	Recall initiated by company
26 Oct 2019	Classified by FDA	+115 days
6 Nov 2019	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for "No Needle Demo Units" to contain a needle.

Product as listed by the FDA

DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03

Where it was distributed

Nationwide within U.S.

Nationwide

Questions about this recall

Why was it recalled?

There is a potential for "No Needle Demo Units" to contain a needle.

Which lots are affected?

UDI: (01)10385609021039(17)XXXXXX(10)XXXXXXXX Lot Number: DM218024

Where was it sold?

Nationwide within U.S.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

4 other products · FDA event 83386

This product is part of a recall event; the main page for the event is DEMO No Needle Corrugated Carton 20 U/D recalled.

Reported	Class	Recall	Company	Reason	Where
6 Nov 2019	CLASS II	DEMO No Needle Corrugated Carton 20 U/D recalled	Valeritas	Other	Nationwide
6 Nov 2019	CLASS II	DEMO No Needle Corrugated Carton 30 U/D recalled	Valeritas	Other	Nationwide
6 Nov 2019	CLASS II	DEMO No Needle Corrugated Carton 40 U/D recalled	Valeritas	Other	Nationwide
6 Nov 2019	CLASS II	DEMO No Needle Corrugated Carton 30 U/D recalled	Valeritas	Other	Nationwide

More recalls from Valeritas

All 5

Reported	Class	Recall	Company	Reason	Where
6 Nov 2019Device	CLASS II	DEMO No Needle Corrugated Carton 30 U/D recalled	Valeritas	Other	Nationwide
6 Nov 2019Device	CLASS II	DEMO No Needle Corrugated Carton 40 U/D recalled	Valeritas	Other	Nationwide
6 Nov 2019Device	CLASS II	DEMO No Needle Corrugated Carton 30 U/D recalled	Valeritas	Other	Nationwide
6 Nov 2019Device	CLASS II	DEMO No Needle Corrugated Carton 20 U/D recalled	Valeritas	Other	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