Recall Z-3182-2026
Stryker Sustainability Solutions · initiated August 19, 2026
Product
REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
Codes / lots: UDI: (01)00885825017248/ Lots: 16029709 16029713 16029905 16038879 16038908 16048968 16048981 16051646 16052906 16053263 16070603 16070983 16074134 16074530 16074759 16092016 16092379 16092572 16104843 16106180 16119023 16119800 16121093 16126431 16126844 16140581 16140608 16140727 16140736 16142688 16160592 16160707 16160912 16161351 16167914 16180911 16188469 16189136 16197549 16210951 16244569 16247119 16247126 16250185 16255569 16267787 16273355 16284965 16303304 16306443 16359846 16360045 16360239 16360667 16364426 16383244 16383259 16384055 16396887 16397027 16427445 16435623 16435843 16436420 16436477 16444099 16444580 16444611 16448679 16448717 16459282 16459305 16459333 16459564 16470988 16488281 16491642 16492270 16492579 16492580 16500270 16500301 16500355 16500477 16508036 16528627 16528847 16531603 16531776 16531851 16552151 16552167 16552179 16552302 16555583 16614437 16614471 16618155 16626048 16637792 16646115 16651856 16652489 16657339 16662201 16682817 16701240 16713799 16713813 16716081 16738446 16746148 16754258 16754364 16759556 16773257 16774058 16774101 16774234 16782321 16800707 16806623 16806634 16806725 16814724 16830838 16841362 16841565 16845689…
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-3182-2026
- Initiated
- August 19, 2026
- Posted by FDA
- September 16, 2026
- Product code
- NLM – Laparoscope, General & Plastic Surgery, Reprocessed
- Quantity
- 7,5966 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
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| 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-3186-2026 | REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MMReusable 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 |