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

Pkg Peek Handle recalled by Stryker Endoscopy

Stryker Endoscopy is recalling Pkg Peek Handle, 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 codes01292013D 0247065C 0341845C 0342941C 0345124C 0345125C 4082014 0540391C 0540392CD 0542893D 0647218D 07122013E 0743480D 0744062D 0843047D 0845027D 0845859D 0846783D 0940144D 0940148D 0940821D 0941601D 0943110D 0943251D 0943541D 0944721D 0945231D 0945465D 1040630D 1040806D 1041063D 1041468D 1042102D 1043037D 1043039D 1044650D 1045037D 1045055D 1045227D 1045481D 1045638D 1045841D 1046702D 11082010A 1141562 1141562D 1141969D 1141970D 1142168D 1143113D 1143150D 1144236D 1144341D 1144655D 1145341D 1145632D 1145809D 1145939 1145939D 1146669D 1146671D 12122013 1241797D 1241938D 1243268D 1243269D 1244956 1244956D 1245522 1245798 1245799 1245799H 1245800 1245977 1340938 1341257 1341872 1343540 1343540H 1343541 1343542 1344000 1344000H 1344251 1440346 1440346H 1440347 1440347H 1440792 1442304 1442799

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-0757-2015
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 PEEK HANDLE, 45CM, P/N 0250181164 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?

01292013D 0247065C 0341845C 0342941C 0345124C 0345125C 4082014 0540391C 0540392CD 0542893D 0647218D 07122013E 0743480D 0744062D 0843047D 0845027D 0845859D 0846783D 0940144D 0940148D 0940821D 0941601D 0943110D 0943251D 0943541D 0944721D 0945231D 0945465D 1040630D 1040806D 1041063D 1041468D 1042102D 1043037D 1043039D 1044650D 1045037D 1045055D 1045227D 1045481D 1045638D 1045841D 1046702D 11082010A 1141562 1141562D 1141969D 1141970D 1142168D 1143113D 1143150D 1144236D 1144341D 1144655D 1145341D 1145632D 1145809D 1145939 1145939D 1146669D 1146671D 12122013 1241797D 1241938D 1243268D 1243269D 1244956 1244956D 1245522 1245798 1245799 1245799H 1245800 1245977 1340938 1341257 1341872 1343540 1343540H 1343541 1343542 1344000 1344000H 1344251 1440346 1440346H 1440347 1440347H 1440792 1442304 1442799

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, 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

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All 238

Reported	Class	Recall	Company	Reason	Where
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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 Insert, Johann Forceps recalled by Stryker Endoscopy	Stryker Endoscopy	Sterility	Nationwide
24 Dec 2014Device	CLASS II	Pkg, Rotating Handle, Ratchet, Insulated Shaft recalled	Stryker Endoscopy	Sterility	Nationwide

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