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U.S. Department of Health and Human Services

Class 2 Device Recall XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM

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 Class 2 Device Recall XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MMsee related information
Date Initiated by FirmAugust 19, 2026
Date PostedSeptember 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3185-2026
Recall Event ID 99634
510(K)NumberK201511 
Product Classification Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
ProductREF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
Code Information UDI: (01)00885825020897/ Lots: 16029001 16032878 16038822 16041414 16044000 16048542 16052751 16054119 16062169 16062738 16066292 16074632 16087947 16087952 16090650 16098040 16107246 16111434 16115899 16115909 16120868 16130680 16130701 16135456 16136279 16138395 16140432 16140568 16142544 16142619 16159304 16160563 16172080 16176548 16186738 16186874 16187194 16187248 16187457 16197336 16201786 16205783 16205810 16205823 16206753 16220653 16220918 16221448 16221453
FEI Number 3009350690
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information ContactStryker Customer Service
800-624-4422
Manufacturer Reason
for Recall		Reusable access port system may crack or seperate during use.
FDA Determined
Cause 2		Device Design
ActionOn August 19, 2026, Stryker Sustainability Solutions (SSS)issued a Urgent: Medical Device recall notice to affected consignees via sales representative and US Mail. SSS ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Immediately check your internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Complete the Business Reply Form or use the QR Code on Attachment A. Response is required. a.If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility.
Quantity in Commerce2682 units
DistributionUS Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina , South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Israel and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NLM
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