Stryker Endoscopy: 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.

Recall number

Z-0665-2015

Recalling firm

Stryker Endoscopy

Product

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.

Status

Terminated

Initiated

2014-11-17

Posted

2014-12-12

Terminated

2015-07-17

Reason

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

Root cause

Error in labeling

Action

Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to endorecall@stryker.com or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at endorecall@stryker.com. For questions regarding this recall call 408-754-2000.

Quantity

180,573 units total

Distribution

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

KOG

Firm FEI

2936485

Firm city

San Jose

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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