Z-2089-2019Class II

Acuject Variable Injection Needle

Name: Z-2089-2019 Acuject Variable Injection Needle
Creator: Wilson-Cook Medical Inc.
Published: 2019-06-14
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2019-06-14 / Terminated / root cause: manufacturing process

FDA source

Wilson-Cook Medical Inc. began a recall of Acuject Variable Injection Needle on 2019-06-14. FDA classified it as Class II and gives the reason as "Potential for occluded injection needles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2089-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-14
Posted: 2019-07-27
Terminated: 2021-04-02
Recalling firm: Wilson-Cook Medical Inc.
Product: Acuject Variable Injection Needle
Product code: FBK Endoscopic Injection Needle, Gastroenterology-Urology
Reason for recall: Potential for occluded injection needles.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Wilson-Cook Medical notified their customer on about 06/14/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. The letter instructed customers to examine inventory for affected devices, quarantine any affected devices, notify customers if the product has been further distributed, and return affected devices to Cook China as soon as possible. The customer was also instructed to complete the provided Recall Return Response form and send it to Cook China.
Quantity in commerce: 24
Distribution: Distributed to China
Product codes and lots: Lot Code W413079; Catalog Number VIN-25; Expiration Date 10/24/2021; UDI Number (01)00827002225268(17)211024(10)W4136079

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2089-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2089-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-27

Product code FBK

K941305Class IIWilson-Cook Variable Length Gi Injection NeedleWilson-Cook Medical, Inc. / cleared 1994-06-02

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)