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RecallWatchMedical Device Safety
Class IIOngoingZ-3182-2026

Stryker Sustainability Solutions recalls REF:2B5LT Ethicon Endo-Surgery

Stryker Sustainability SolutionsTempe, AZ, United StatesReported Sep 23, 2026 · 6 days ago
Legal News Analyst ·

Reason for recall

Reusable access port system may crack or seperate during use.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MMREF
    250 affected lots
    1602970916029713160299051603887916038908160489681604898116051646
    +242 more1605290616053263160706031607098316074134160745301607475916092016160923791609257216104843161061801611902316119800161210931612643116126844161405811614060816140727161407361614268816160592161607071616091216161351161679141618091116188469161891361619754916210951162445691624711916247126162501851625556916267787162733551628496516303304163064431635984616360045163602391636066716364426163832441638325916384055163968871639702716427445164356231643584316436420164364771644409916444580164446111644867916448717164592821645930516459333164595641647098816488281164916421649227016492579164925801650027016500301165003551650047716508036165286271652884716531603165317761653185116552151165521671655217916552302165555831661443716614471166181551662604816637792166461151665185616652489166573391666220116682817167012401671379916713813167160811673844616746148167542581675436416759556167732571677405816774101167742341678232116800707168066231680663416806725168147241683083816841362168415651684568916854686168735431688258316883091168897121689947616911147169147771691817016918780169233071694070316944189169483211695213816952313169773121698110016981383169814011698514617001229170056611701028217010765170107771703317217035546170408091704143917045802170639701706401817080237170851151708516217108912171091461710962017112702171212361713950317139820171472321715026817150996171746001717506317175092171751561717872317185753171859201718927417189482171897601720039517200428172004591720947017209525172320021723503717235643172356581723975717251106172585261725872217258808172588201727510617289383172895911728999517294320173107641732542317325475173277211732788217341993173459671734601617353315173537011736959017369751173788601737887317378943173908911739107817391084174080751740814517420057174201851743076217431184174313641744954617456945174695871747352717473747174962221750026517511819175214621752591717541289175453481754535317551198175514841757688717608061176084381760879917614359

What the firm is doing

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.

DistributionShow details

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, 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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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