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

Pkg Insert, Debakey Forceps recalled by Stryker Endoscopy

Stryker Endoscopy is recalling Pkg Insert, Debakey 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 codes740174 746372 847633 848129 940133 940349 940374 1042921 1044418 1045036 1046691 1141654 1141925 1142630 1143140 1144223 1145066 1145938 1242452 1243548 1243795 1244657 1245116 1245601 1246159 1341990 1342387 1342748 1343007 1343306 1343424 1343729 1344276 1346100 1346243 1346419 1346659 1440421 1440480 1441378 1441632 1441833 1442623 1443218

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-0743-2015
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, 45CM, DEBAKEY FORCEPS, P/N 0250080748 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?

Which lots are affected?

740174 746372 847633 848129 940133 940349 940374 1042921 1044418 1045036 1046691 1141654 1141925 1142630 1143140 1144223 1145066 1145938 1242452 1243548 1243795 1244657 1245116 1245601 1246159 1341990 1342387 1342748 1343007 1343306 1343424 1343729 1344276 1346100 1346243 1346419 1346659 1440421 1440480 1441378 1441632 1441833 1442623 1443218

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 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.

Reported	Class	Recall	Company	Reason	Where
24 Dec 2014	CLASS II	Pkg, Bipolar Forceps, Fenestrated recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Endo Metzenbaum Scissors, Curved recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Alligator Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Insert, Fenestrated Grasper recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Bipolar Forceps, Micro Tip recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Allis Double Row Teeth recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Mixter Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Right Angle Dissector, Long Jaw recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Bullet Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Trocar, Pyramidal Tip, Short recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Aspiration Needle recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Hook Scissors recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Grasper Forceps, Narrow Jaw recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Myoma Drill Length recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Palpation Probe Graduated recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Needle Holder, Striaght recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Mixter Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Peek Monopolar Handle recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Shaft, Needle Holder Curved Left recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Insert, Metzenbaum Curved Scissors, Long Jaw recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Bipolar Forceps, Micro Tip recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert Biopsy Forceps, Spoon W/pin recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Fixable Cone For Hasson recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Mixter Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Schertl Grasper, Fenestrated recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Atraumatic Forceps, Double Action recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Bipolar Forceps, Fenestrated recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Biopsy Punch recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Grasper Forceps, Tissue recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Blunt With Spoon, Grasper recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Metzenbaum, Curved, Long Scissors recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Blunt Forceps, Blunt, Serrated, Spoon recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Hook Scissors recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Micro Grasper recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Bipolar Forceps, Paddle recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Trocar, Pyramidal Tip recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Atraumatic Forceps, Double Action recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Atraumatic Grasper Forceps, Single Action recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Atraumatic Grasper, Double Action recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Endo Grasper recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Cannula Auto Valve, Stopcock, Short recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Maryland Dissecting Forceps, Curved Left recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Grasper Forceps, Serrated recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Palpation Probe Graduated recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Retention Grasper recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Schertel Forceps, Fenestrated recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Park Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Right Angle Dissector, Long Jaw recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Park Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Metzenbaum Scissors, Curved, Long recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Peek Monopolar Handle recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Paddle Babcock recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Grasper Forceps, Delicate, Fenestrated recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Dissecting & Grasper Forceps, Serrated recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Allis Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Babcock Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Dorsey Grasper recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Park Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Bipolar Forceps, Fenestrated recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Biopsy Forceps, Spoon W/pin recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Kelly Forceps, Curved Left recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Myoma Drill Length recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Biopsy Punch recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Insert, Fundus Grasper Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Biopsy Forceps, Punch recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Bipolar Forceps, Paddle recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg. Insert, Babcock Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Mini Metzenbaum Scissors, Curved recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Grasper Forceps, Narrow Jaw recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Needle Nose Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Retention Grasper recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Metzenbaum Scissors, Curved Long recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insulated Shaft, For Bipolar Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert,perforator recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Dissecting Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Atraumatic Grasper, Double Action recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Endo Grasper recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Atraumatic Forceps, Single Action recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Needle Holder, Curved Right recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Needle Nose Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Rotating Handle, W/ratchet, Insulated Shaft recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Straight Needleholder recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Maryland Forceps, Curved, Left recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Rotating Handle, Ratchet, Insulated/shaft recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Blunt Grasper recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Maryland, Forceps Curved recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Straight Needleholder recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Rotating Handle, Insulated Shaft/ Handle Length recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Pkg, Hook Scissors recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Hasson Cannula Automatic Valve, Stop Cock recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Atraumatic Grasper Forceps, Double Action recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Rotating Handle, W/ratchet, Insulated Shaft recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Ring Handle recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Trocar, Pyramidal Tip recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Fundus Grasper, 29cpkg Insert, Alligator Grasper recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Needle Nose Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Cannula, Automatic Valve Stop Cock, W/o Trocar recalled	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Insert, Kelly Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg Insert, Bowel Grasper Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014	CLASS II	Pkg, Aspiration Needle recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide

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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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