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

Pkg Insert, Cobra Grasper recalled by Stryker Endoscopy

Stryker Endoscopy is recalling Pkg Insert, Cobra 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 codes842586 844134 846790 1045475 1143118 1143135
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-0765-2015
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

Timeline

17 Nov 2014Recall initiated by company
17 Dec 2014Classified by FDA+30 days
24 Dec 2014Published 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, 3MM INSERT, COBRA GRASPER, 20CM, P/N 0250282007 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

Why was it recalled?

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

Which lots are affected?

842586 844134 846790 1045475 1143118 1143135

Where was it sold?

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.

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 69838

This product is part of a recall event; the main page for the event is Pkg, Bipolar Forceps, Fenestrated recalled by Stryker Endoscopy.

ReportedClassRecallCompanyReasonWhere
CLASS IIPkg, Bipolar Forceps, Fenestrated recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Endo Metzenbaum Scissors, Curved recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Alligator Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Insert, Fenestrated Grasper recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Bipolar Forceps, Micro Tip recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Allis Double Row Teeth recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Mixter Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Right Angle Dissector, Long Jaw recalledStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Bullet Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Trocar, Pyramidal Tip, Short recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Aspiration Needle recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Hook Scissors recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Grasper Forceps, Narrow Jaw recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Myoma Drill Length recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Palpation Probe Graduated recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Needle Holder, Striaght recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Mixter Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Peek Monopolar Handle recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Shaft, Needle Holder Curved Left recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Insert, Metzenbaum Curved Scissors, Long Jaw recalledStryker EndoscopySterilityNationwide
CLASS IIPkg, Bipolar Forceps, Micro Tip recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert Biopsy Forceps, Spoon W/pin recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Fixable Cone For Hasson recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Mixter Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Schertl Grasper, Fenestrated recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Atraumatic Forceps, Double Action recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Bipolar Forceps, Fenestrated recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Biopsy Punch recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Grasper Forceps, Tissue recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Blunt With Spoon, Grasper recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Metzenbaum, Curved, Long Scissors recalledStryker EndoscopySterilityNationwide
CLASS IIPkg, Blunt Forceps, Blunt, Serrated, Spoon recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Hook Scissors recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Micro Grasper recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Bipolar Forceps, Paddle recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Trocar, Pyramidal Tip recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Atraumatic Forceps, Double Action recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Atraumatic Grasper Forceps, Single Action recalledStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Atraumatic Grasper, Double Action recalledStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Endo Grasper recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Cannula Auto Valve, Stopcock, Short recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Maryland Dissecting Forceps, Curved Left recalledStryker EndoscopySterilityNationwide
CLASS IIPkg, Grasper Forceps, Serrated recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Palpation Probe Graduated recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Retention Grasper recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Schertel Forceps, Fenestrated recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Park Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Right Angle Dissector, Long Jaw recalledStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Park Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Metzenbaum Scissors, Curved, Long recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Peek Monopolar Handle recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Paddle Babcock recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Grasper Forceps, Delicate, Fenestrated recalledStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Dissecting & Grasper Forceps, Serrated recalledStryker EndoscopySterilityNationwide
CLASS IIPkg, Allis Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Babcock Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Dorsey Grasper recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Park Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Bipolar Forceps, Fenestrated recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Biopsy Forceps, Spoon W/pin recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Kelly Forceps, Curved Left recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Myoma Drill Length recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Biopsy Punch recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Insert, Fundus Grasper Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Biopsy Forceps, Punch recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Bipolar Forceps, Paddle recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg. Insert, Babcock Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Mini Metzenbaum Scissors, Curved recalledStryker EndoscopySterilityNationwide
CLASS IIPkg, Grasper Forceps, Narrow Jaw recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Needle Nose Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Retention Grasper recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Metzenbaum Scissors, Curved Long recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insulated Shaft, For Bipolar Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert,perforator recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Dissecting Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Atraumatic Grasper, Double Action recalledStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Endo Grasper recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Atraumatic Forceps, Single Action recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Debakey Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Needle Holder, Curved Right recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Needle Nose Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Rotating Handle, W/ratchet, Insulated Shaft recalledStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Straight Needleholder recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Maryland Forceps, Curved, Left recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Rotating Handle, Ratchet, Insulated/shaft recalledStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Blunt Grasper recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Maryland, Forceps Curved recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Straight Needleholder recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Rotating Handle, Insulated Shaft/ Handle Length recalledStryker EndoscopySterilityNationwide
CLASS IIPkg, Pkg, Hook Scissors recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Hasson Cannula Automatic Valve, Stop Cock recalledStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Atraumatic Grasper Forceps, Double Action recalledStryker EndoscopySterilityNationwide
CLASS IIPkg, Rotating Handle, W/ratchet, Insulated Shaft recalledStryker EndoscopySterilityNationwide
CLASS IIPkg, Ring Handle recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Trocar, Pyramidal Tip recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Fundus Grasper, 29cpkg Insert, Alligator Grasper recalledStryker EndoscopySterilityNationwide
CLASS IIPkg, Needle Nose Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg, Cannula, Automatic Valve Stop Cock, W/o Trocar recalledStryker EndoscopySterilityNationwide
CLASS IIPkg, Insert, Kelly Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
CLASS IIPkg Insert, Bowel Grasper Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide

More recalls from Stryker Endoscopy

All 238
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIPneumoSure XL High Flow Insufflator recalled by Stryker EndoscopyStryker EndoscopyOtherNationwide
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DeviceCLASS IIPkg, Pennington Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
DeviceCLASS IIPkg Peek Handle recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide
DeviceCLASS IIPkg Insert, Johann Forceps recalled by Stryker EndoscopyStryker EndoscopySterilityNationwide

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