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

Pkg, Cannula, Automatic Valve Stop Cock, W/o Trocar recalled

Stryker Endoscopy is recalling Pkg, Cannula, Automatic Valve Stop Cock, W/o Trocar, 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 codes34084 36925 38749 38885 38955 39654 44365 44521 44924 44925 45030 45806 46020 46328 46472 47128 47157 47614 47955 48064 48403 48404 48645 48699 48768 49015 49479 49832 50044 50237 50859 51025 51179 51390 51612 51910 52116 52651 52998 53778 57318 57476 58259 59578 59722 59739 61128 62393 63206 63761 64136 65374 65921 67020 68011 68985 70523 74752 75614 75641 76643 76818 76961 78384 79424 80272 81574 83533 85051 85137 85913 86043 86264 86431 89121

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-0665-2015
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, CANNULA, 11MM, AUTOMATIC VALVE STOP COCK, W/O TROCAR, P/N 0250080174. 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

Is Pkg, Cannula, Automatic Valve Stop Cock, W/o Trocar recalled?

Yes. Stryker Endoscopy recalled Pkg, Cannula, Automatic Valve Stop Cock, W/o Trocar on 17 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0665-2015.

Why was it recalled?

Which lots are affected?

34084 36925 38749 38885 38955 39654 44365 44521 44924 44925 45030 45806 46020 46328 46472 47128 47157 47614 47955 48064 48403 48404 48645 48699 48768 49015 49479 49832 50044 50237 50859 51025 51179 51390 51612 51910 52116 52651 52998 53778 57318 57476 58259 59578 59722 59739 61128 62393 63206 63761 64136 65374 65921 67020 68011 68985 70523 74752 75614 75641 76643 76818 76961 78384 79424 80272 81574 83533 85051 85137 85913 86043 86264 86431 89121

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 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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