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

Pkg, Pkg, Hook Scissors recalled by Stryker Endoscopy

Stryker Endoscopy is recalling Pkg, Pkg, Hook Scissors, 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 codes41490 44630 140583 142467 142469 143688 144270 246031 440310 443401 443405 443406 443407 542490 542498 542499 641965 641966 641968 645668 741519 741520 741521 741523 744992 744994 744995 747000 747001 747002 841991 842244 842246 842248 842259 842263 842267 842271 842876 941705 942762 942846 943012 943044 943107 943247 943417 943747 944089 944704 944838 944885 945128 945554 945555 945557 945558 945559 945562 945564 945565 945568 945569 1042239 1042474 1044885 1046102 1046734 1046735 1140692 1141608 1142179 1143096 1143097 1144503 1145104 1145105 1146377 1146378 1147161 1147162 1241404 1242145 1242261 1243810 1244133 1244439 1245093 1245235 1245831 1246051 1246185 1340227 1340932 1340933 1341825 1342200 1342201 1342202 1343515 1343516 1345798 1440785 1441076 1442552

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-0639-2015
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, PKG, HOOK SCISSORS, P/N 0250080260. 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?

41490 44630 140583 142467 142469 143688 144270 246031 440310 443401 443405 443406 443407 542490 542498 542499 641965 641966 641968 645668 741519 741520 741521 741523 744992 744994 744995 747000 747001 747002 841991 842244 842246 842248 842259 842263 842267 842271 842876 941705 942762 942846 943012 943044 943107 943247 943417 943747 944089 944704 944838 944885 945128 945554 945555 945557 945558 945559 945562 945564 945565 945568 945569 1042239 1042474 1044885 1046102 1046734 1046735 1140692 1141608 1142179 1143096 1143097 1144503 1145104 1145105 1146377 1146378 1147161 1147162 1241404 1242145 1242261 1243810 1244133 1244439 1245093 1245235 1245831 1246051 1246185 1340227 1340932 1340933 1341825 1342200 1342201 1342202 1343515 1343516 1345798 1440785 1441076 1442552

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 Insert, Debakey Forceps 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, 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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All 238

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4 May 2016Device	CLASS II	PneumoSure XL High Flow Insufflator recalled by Stryker Endoscopy	Stryker Endoscopy	Other	Nationwide
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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