45cm Laparoscopic Instruments Sterilization tray recallZ-2612-2011 · Stryker Endoscopy · initiated Jun 8, 2011
Terminated All recalls posted in June 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Endoscopy or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected]. Questions can be answered by calling 1-800-624-4422 or by e-mail at [email protected].
Recall details
- Recall number
- Z-2612-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 8, 2011
- Posted by the FDA
- Jun 22, 2011
- Recalling firm
- Stryker Endoscopy
- Quantity
- 603
- Product code
- KCT
- FDA submissions
- K960738
- Distribution
- Worldwide Distribution--USA (nationwide) and countries of Brazil, Canada, Chili, Germany , Korea, Mexico, Philippines, Poland, Portugal, Singapore, Sweden, Switzerland, and Taiwan.
Product description
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.
Code information (models, lots, serial numbers)
Model number 250-015-704. All serial/lot numbers.
Other devices under the same FDA submission
1 device cleared under K960738 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- N/A 9734692Medtronic Navigation, Inc. · Sterilization wrap containers, trays, cassettes & other accessories1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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