CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report

Pkg Insert, Retention Grasper recalled by Stryker Endoscopy

Stryker Endoscopy is recalling Pkg Insert, Retention Grasper, distributed nationwide in the US. The recall was initiated on 17 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes44496 140605 140606 345140 641239 846761 847639 940558 941264 941600 1040627 1040792 1041613 1042525 1043030 1045850 1047039 1141968 1144639 1145068 1146344 1241175 1242199 1242458 1243947 1246162 1340222D 1341522 1341572 1342759 1345289 1345603 141871 1440440 1440691 1441168 1442626 344116 642115

Quantity recalled180,573 units total

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-0725-2015
FDA event ID: 69838
Recalling firm: Stryker Endoscopy, San Jose, CA
Classification: Class II
Status: Terminated
Recall initiated: 17 Nov 2014
FDA classified: 17 Dec 2014
Reported: 24 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

17 Nov 2014	Recall initiated by company
17 Dec 2014	Classified by FDA	+30 days
24 Dec 2014	Published in enforcement report	+7 days

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

Reason for recall

The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods

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

PKG, 5MM INSERT, RETENTION GRASPER, 33CM, P/N 0250080697 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

Nationwide Puerto Rico

Questions about this recall

Is Pkg Insert, Retention Grasper recalled?

Yes. Stryker Endoscopy recalled Pkg Insert, Retention Grasper on 17 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0725-2015.

Why was it recalled?

Which lots are affected?

44496 140605 140606 345140 641239 846761 847639 940558 941264 941600 1040627 1040792 1041613 1042525 1043030 1045850 1047039 1141968 1144639 1145068 1146344 1241175 1242199 1242458 1243947 1246162 1340222D 1341522 1341572 1342759 1345289 1345603 141871 1440440 1440691 1441168 1442626 344116 642115

Where was it sold?

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 Stryker Endoscopy

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1 Jul 2015Device	CLASS II	Serfas 90 degree Energy Probe recalled by Stryker Endoscopy	Stryker Endoscopy	Device Malfunction	Nationwide
24 Dec 2014Device	CLASS II	Pkg, Pennington Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014Device	CLASS II	Pkg Peek Handle recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014Device	CLASS II	Pkg Insert, Johann Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide

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