Z-2265-2013Class II

ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard...

Name: Z-2265-2013 ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard...
Creator: Endoplus, Inc.
Published: 2013-07-15
License: https://open.fda.gov/license/

Endoplus / initiated 2013-07-15 / Terminated / root cause: manufacturing process

FDA source

Endoplus, Inc. began a recall of ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower... on 2013-07-15. FDA classified it as Class II and gives the reason as "Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures". 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-2265-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-15
Posted: 2013-09-21
Terminated: 2016-02-08
Recalling firm: Endoplus
Product: ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Letters were sent on 7/15/2013 to all customers notifying them of the recall. The letters requested that customers return the recalled devices via private courier using an enclosed account number. Replacement devices will be made available upon customer request.
Quantity in commerce: 9 units
Distribution: Distributed in the states of FL, TX, and VA.
Product codes and lots: Item: 345VA; Lot Number: F3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2265-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2264-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-21
Z-2265-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-21

Product code GCJ

K925079Class IILaparoscopic Inst. (Scissors,forceps,needleholder)Endo Technic Corp. / cleared 1994-08-24

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)