Z-2313-2017Class II

Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open...

Name: Z-2313-2017 Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open...
Creator: Cook Inc.
Published: 2017-05-01
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2017-05-01 / Terminated / root cause: sterility

FDA source

Cook Inc. began a recall of Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct... on 2017-05-01. FDA classified it as Class II and gives the reason as "COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2313-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-01
Posted: 2017-06-08
Terminated: 2019-03-26
Recalling firm: Cook Incorporated
Product: Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.
Product code: FHQ Holder, Needle, Gastroenterologic
Reason for recall: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: The firm, Cook Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 26, 2017 to its customers. Letters were mailed to customers via courier on April 28, 2017. The letter described the product, problem, and actions to be taken. The customers were instructed to: examine your inventory immediately to identify and quarantine affected products; complete and return the required Acknowledgment and Receipt form (even if you do not have affected product) via fax (812.339.7316) or email ([email protected]); return and discard any affected products, and Immediately report any adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email at [email protected]. Should you have any medical questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Quantity in commerce: 327 Lots, 725 units
Distribution: Worldwide Distribution - US (nationwide) and countries of: Australia, Austria, Belgium, Bahrain, Canada, China, Costa Rica, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Lithuania, Latvia, Malaysia, Netherlands, Romania, Russia, Saudi Arabia, Singapore, Spain, Switzerland, United Arab Emirates, and United Kingdom.
Product codes and lots: CATALOG NUMBER: and GPN: J-ENH-033100 & G16426, J-ENH-053100 & G16427, J-ENH-053120 & G16428, J-ENH-053130 & G16429 Dates of Manufacture: January 2012 to February 2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2313-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2310-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-07
Z-2311-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-07
Z-2312-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-07
Z-2313-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-07
Z-2314-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-07
Z-2315-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-07

Product code FHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)