CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report
Pkg, Bipolar Forceps, Fenestrated recalled by Stryker Endoscopy
Stryker Endoscopy is recalling Pkg, Bipolar Forceps, Fenestrated, 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
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-0596-2015
- 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, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 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.
Questions about this recall
Is Pkg, Bipolar Forceps, Fenestrated recalled?
Yes. Stryker Endoscopy recalled Pkg, Bipolar Forceps, Fenestrated on 17 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0596-2015.
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?
06CON06113 0816243/0817410 0913221/0817442 0913222/0817442 1015164/1014813 1015164/1015778 1016405/1016061 1016405/1016400 1016405/1016401 1113335/1113339 1213126/1114543 1213127/1114543 1213127/1213123 1214001/1313047 1313947/1313946 0817389/0817444 0913565/0913326 0915791/0915061 0915791/1013608 0915894/0915061 0915895/0915061 1014635/1015778 1015165/1013609 1015165/1015778 1015773/1015778 1015774/1015778 1015862/1016061 1016124/1016061 1016125/1016062 1016128/1016061 1016406/1016400 1016408/1016400 1016408/1016826 1016562/1016400 1113333/1016063 1113333/1113018 1113333/1113136 1113333/1113339 1115969/1115651 1116112/1115651 1116113/1115651 1116114/1115651 1116115/1115651 1116256/1115651 1213128/1213731 1213973/1213978 1213974/1213731 1213974/1213978
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 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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