Z-2004-2019Class II

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

Name: Z-2004-2019 Terumo Needle, 18G x 1", Product Code NN1825R
Creator: Terumo Medical Corporation
Published: 2019-02-08
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2019-02-08 / Terminated / root cause: packaging

FDA source

Terumo Medical Corporation began a recall of Terumo Needle, 18G x 1", Product Code NN1825R on 2019-02-08. FDA classified it as Class II and gives the reason as "There is a potential for a loss of package integrity that may compromise the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2004-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-08
Posted: 2019-07-22
Terminated: 2020-05-08
Recalling firm: Terumo Medical Corp.
Product: Terumo Needle, 18G x 1", Product Code NN1825R
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: There is a potential for a loss of package integrity that may compromise the sterility of the product.
Root cause tag: packaging
FDA root cause: Packaging
Action: Urgent Voluntary Medical Device Recall notification letters dated 2/8/19 were sent to customers.
Quantity in commerce: 810,000
Distribution: The products were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX.
Product codes and lots: Lot Numbers 180714C, 180723C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2004-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1998-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-1999-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2000-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2001-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2002-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2003-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2004-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2005-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2006-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22

Product code FMI

K121607Class IITerumo(r) NeedleTerumo (Philippines) Corporation / cleared 2012-11-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)