CLASS II Device recall · Reported 2 Oct 2013 · FDA Enforcement Report

Precision Laparoscopic Instruments recalled by Endoplus

Endoplus is recalling Endoplus; Precision Laparoscopic Instruments, distributed in Florida, Texas, Virginia. The recall was initiated on 15 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem: 345VA; Lot Number: F3

Quantity recalled9 units

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-2265-2013
FDA event ID: 66063
Recalling firm: Endoplus, Mundelein, IL
Classification: Class II
Status: Terminated
Recall initiated: 15 Jul 2013
FDA classified: 21 Sep 2013
Reported: 2 Oct 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

15 Jul 2013	Recall initiated by company
21 Sep 2013	Classified by FDA	+68 days
2 Oct 2013	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.

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

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.

Where it was distributed

Distributed in the states of FL, TX, and VA.

Florida Texas Virginia

Questions about this recall

Is Precision Laparoscopic Instruments recalled?

Yes. Endoplus recalled Precision Laparoscopic Instruments on 15 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-2265-2013.

Why was it recalled?

Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.

Which lots are affected?

Item: 345VA; Lot Number: F3

Where was it sold?

Distributed in the states of FL, TX, and VA.

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 Endoplus

All 2

Reported	Class	Recall	Company	Reason	Where
2 Oct 2013Device	CLASS II	Precision Laparoscopic Instruments recalled by Endoplus	Endoplus	Sterility	FL, TX, VA

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