Recall Z-3186-2026

Stryker Sustainability Solutions · initiated August 19, 2026

Open, Classified

Product

REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM

Codes / lots: UDI: (01)00885825014193/ Lots: 16028826 16028944 16032429 16032455 16037857 16042594 16043150 16046641 16048041 16048162 16052733 16062124 16066285 16070101 16070223 16070912 16074744 16084153 16087588 16096162 16098296 16099148 16111195 16111423 16112459 16115071 16120538 16126420 16126902 16131433 16135397 16135402 16139681 16140445 16142642 16142674 16146017 16146188 16146587 16147022 16155907 16156189 16160070 16160805 16160867 16161367 16168109 16168270 16172196 16172940 16177138 16177252 16180562 16188453 16189060 16189428 16192354 16192768 16197315 16201740 16202087 16202127 16207388 16210404 16213753 16214274 16214290 16222349 16224767 16225404 16229770 16233367 16237281 16238596 16246288 16247086 16247491 16252145 16259463 16266998 16270336 16273726 16273956 16281200 16281683 16285515 16293349 16298285 16298478 16303182 16303680 16306399 16310061 16310747 16313556 16317868 16331016 16331380 16335107 16338939 16339687 16339734 16346961 16347809 16347813 16354890 16359193 16376457 16379762 16379864 16379961 16383758 16387666 16397456 16397619 16397931 16403371 16407611 16408119 16412167 16412599 16414020 16414054 16414065 16422560 16422600 16422933 16427552 16431525…

Reason for recall

Reusable access port system may crack or seperate during use.

FDA-determined cause: Device Design

Action taken

On 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.

Details

Recall number
Z-3186-2026
Initiated
August 19, 2026
Posted by FDA
September 16, 2026
Product code
NLM – Laparoscope, General & Plastic Surgery, Reprocessed
Quantity
205,704 units
Distribution
US 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…
Recalling firm
Stryker Sustainability Solutions, Tempe, AZ

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-3182-2026 REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY &…Reusable access port system may crack or seperate during use. 08/19/2026Open, Classified
Z-3183-2026 REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY &…Reusable access port system may crack or seperate during use. 08/19/2026Open, Classified
Z-3184-2026 REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MMReusable access port system may crack or seperate during use. 08/19/2026Open, Classified
Z-3185-2026 REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MMReusable access port system may crack or seperate during use. 08/19/2026Open, Classified
Z-3187-2026 REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MMReusable access port system may crack or seperate during use. 08/19/2026Open, Classified