CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report

Terumo Needle, Product recalled by Terumo Medical

Terumo Medical is recalling Terumo Needle, Product, distributed in 12 states. The recall was initiated on 8 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers 180714C, 180723C

Quantity recalled810,000

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-2004-2019
FDA event ID: 82212
Recalling firm: Terumo Medical, Elkton, MD
Classification: Class II
Status: Terminated
Recall initiated: 8 Feb 2019
FDA classified: 22 Jul 2019
Reported: 31 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Syringes & Needles

Timeline

8 Feb 2019	Recall initiated by company
22 Jul 2019	Classified by FDA	+164 days
31 Jul 2019	Published in enforcement report	+9 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 a loss of package integrity that may compromise the sterility of the product.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Terumo Needle, 18G x 1", Product Code NN1825R

Where it was distributed

The products were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX.

Florida Indiana Kansas Kentucky Massachusetts Missouri New Hampshire Nevada Pennsylvania South Carolina Tennessee Texas

Questions about this recall

Is Terumo Needle, Product recalled?

Yes. Terumo Medical recalled Terumo Needle, Product on 8 Feb 2019. The recall is Class II and its status is Terminated. Recall number Z-2004-2019.

Why was it recalled?

There is a potential for a loss of package integrity that may compromise the sterility of the product.

Which lots are affected?

Lot Numbers 180714C, 180723C

Where was it sold?

The products were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Terumo Medical

All 39

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Glidesheath Slender A-kit 6f .021gw recalled by Terumo Medical	Terumo Medical	Packaging Defects	Nationwide
31 Jul 2019Device	CLASS II	Terumo Sur-vet Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Sur-vet Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Sur-vet Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states

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