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

Pkg, Insert, Dorsey Grasper Forceps recalled by Stryker Endoscopy

Stryker Endoscopy is recalling Pkg, Insert, Dorsey Grasper Forceps, 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 codes746661 842498 940096 940141 943492 943738 944195 944819 1040538 1042104 1042442 1042910 1042911 1045074 1045848 1141786 1142613 1144393 1240140 1241903 1242135 1242925 1244593 1245032 1245544 1246160 1341518 1342003 1342747 1343305 1343422 1343727 1346658 1440420 1440479 1440957 1441379 1442622 1442788 1443586

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-0740-2015
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, 45CM, INSERT, DORSEY GRASPER FORCEPS, P/N 0250080736 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, Dorsey Grasper Forceps recalled?

Yes. Stryker Endoscopy recalled Pkg, Insert, Dorsey Grasper Forceps on 17 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0740-2015.

Why was it recalled?

Which lots are affected?

746661 842498 940096 940141 943492 943738 944195 944819 1040538 1042104 1042442 1042910 1042911 1045074 1045848 1141786 1142613 1144393 1240140 1241903 1242135 1242925 1244593 1245032 1245544 1246160 1341518 1342003 1342747 1343305 1343422 1343727 1346658 1440420 1440479 1440957 1441379 1442622 1442788 1443586

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.

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