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

Pkg Insert, Endo Metzenbaum Scissors, Curved recalled

Stryker Endoscopy is recalling Pkg Insert, Endo Metzenbaum Scissors, Curved, 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 codes247425 345126 443972 542154 643084 744694 745080 745631 746499 747596 845622 940158 941057 942853 0943888E 0943889E 0945145E 0945724E 1040112E 1040803E 1041624E 1042486E 1042718E 1042721E 1043803E 1046698E 1142619E 1143800E 1145679E 1146359E 114635E 1146663E 1242122E 1242714E 1242919E 1243536E 1243952E 1244528E 1244582E 1244993E 1245516E 1246169E 1246647E 1340192 1340541 1343411 1343710 1344029 1344298 1345423 1345645 1346655 1440435 1440679 1441180 1441180E 1441815 1442256 1442808 1443226 1443650

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-0703-2015
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, ENDO METZENBAUM SCISSORS, CURVED 45CM, P/N 0250080575 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, Endo Metzenbaum Scissors, Curved recalled?

Yes. Stryker Endoscopy recalled Pkg Insert, Endo Metzenbaum Scissors, Curved on 17 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0703-2015.

Why was it recalled?

Which lots are affected?

247425 345126 443972 542154 643084 744694 745080 745631 746499 747596 845622 940158 941057 942853 0943888E 0943889E 0945145E 0945724E 1040112E 1040803E 1041624E 1042486E 1042718E 1042721E 1043803E 1046698E 1142619E 1143800E 1145679E 1146359E 114635E 1146663E 1242122E 1242714E 1242919E 1243536E 1243952E 1244528E 1244582E 1244993E 1245516E 1246169E 1246647E 1340192 1340541 1343411 1343710 1344029 1344298 1345423 1345645 1346655 1440435 1440679 1441180 1441180E 1441815 1442256 1442808 1443226 1443650

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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