FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: 45cm Laparoscopic Instruments Sterilization tray. Manufactured by: Stryker Endoscopy, 5900 Optical Court,San Jose, CA 95138 Designed to hold laparoscopic surgical manual instruments which are intended for cutting, holding, grasping and manipulating tissue, organs, organ area, surgical auxiliaries such as suturing material. The 45cm Lap tray can hold up to 11 instruments in the top tier and a combination of instruments in the bottom tier provided that the total weight of the loaded tray does not exceed 6.53 kg.
- Recall number
- Z-2612-2011
- Recalling firm
- Stryker Endoscopy
- Product
- 45cm Laparoscopic Instruments Sterilization tray. Manufactured by: Stryker Endoscopy, 5900 Optical Court,San Jose, CA 95138 Designed to hold laparoscopic surgical manual instruments which are intended for cutting, holding, grasping and manipulating tissue, organs, organ area, surgical auxiliaries such as suturing material. The 45cm Lap tray can hold up to 11 instruments in the top tier and a combination of instruments in the bottom tier provided that the total weight of the loaded tray does not exceed 6.53 kg.
- Status
- Terminated
- Initiated
- 2011-06-08
- Posted
- 2011-06-22
- Terminated
- 2011-10-25
- Reason
- During testing and review, Stryker Endoscopy discovered that the sterilization parameters for the 132 degree C gravity steam sterilization cycle in the IFU may not consistently sterilize all instruments in the 45cm Laparoscopic Instruments Tray.
- Root cause
- Nonconforming Material/Component
- Action
- Stryker Endoscopy sent a "URGENT: DEVICE CORRECTION" letter dated June 8, 2011 to affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to discard all old Instructions for Use sheets for their 45cm Laparoscopic Tray and download the new IFU from the URL link:http://stryker.com/45cm tray. Additionally, customers were instructed to complete and return an attached "acknowledgement of receipt" form and fax to 408-754-8378 or scan and e-mail to trays@stryker.com. Questions can be answered by calling 1-800-624-4422 or by e-mail at trays@stryker.com.
- Quantity
- 603
- Distribution
- Worldwide Distribution--USA (nationwide) and countries of Brazil, Canada, Chili, Germany , Korea, Mexico, Philippines, Poland, Portugal, Singapore, Sweden, Switzerland, and Taiwan.
- Lot, serial or model codes
- Model number 250-015-704. All serial/lot numbers.
- 510(k) numbers
- ["K960738"]
- PMA numbers
- not on file
- Product code
- KCT
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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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