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Class IIOngoingZ-0543-2026

Auris Health, Inc recalls MONARCH Bronchoscope. Model Number: MBR-000211-B

Auris Health, IncSanta Clara, CA, United StatesReported Nov 26, 2025 · 7 months ago
Legal News Analyst ·

Reason for recall

Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

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

  • MONARCH Bronchoscope. Model Number:MBR-000211-B
    Model Number
    400 affected lots
    13116771311678131167913116801311681131168213116831311684
    +392 more13116851311686131168713116881311722131172313117241311725131172613117271311730131173124042204892404220490240422049124042204922404220493240422049424042204952404220633240422063424042206352404220636240423039524042303962404230412240423041324042304142404230415240423041624042304172404230418240423041924042505702404250571240429088224042908832404290884240429088524042908862404290887240429088824042908892404290890240429089124042908922404290893240429089424042908952404290896240430069724043006982404300699240430070024043007012404300702240430070324043007042404300705240430070624043007072404300708240430070924050108082405010809240502063724050206382405020639240502064024050206412405020642240508052424050805252405080526240508052724050805282405080529240508063624050905642405090565240509056624050905672405090568240509056924050905702405090571240509057224050905732405160716240516071724051607182405200526240520052724052005282405200529240520053024052005312405200532240520072524052007262405200727240520079724052007982405200799240520080024052008022405200803240520080424052008052405200806240520080724052008082405200809240520081024052008112405200812240520081324052008142405200815240520081624052104402405210441240521044224052108032405210804240521080524052109232405210924240521092524052109262405210927240521092824052109292405210930240521093124052109322405210933240521093424052109352405210937240521093824052109392405210940240521094124052109422405210943240522011124052201122405220113240522011424052201152405220174240522017524052201762405220238240522023924052202402405220241240522043224052204332405220434240522043524052204362405220437240522043824052204392405220440240523043724052305332405230534240523053524052305362405230537240523053824052305392405230540240523054124052305422405230543240523054424052305452405230546240523054724052804012405280758240528075924052807602405280761240528076224052807632405280764240530040224053007982405300799240530080024053008012405300802240530080324053008042405300805240603089224060308932406030894240603089524060308962406030897240603090124060309022406040730240604073124060407322406040733240604073424060407352406040736240606040124060607352406100160240610016124061001622406100163240610016424061001652406100241240611009224061100942406110095240611009624061100972406110098240611011524061101172406110118240613081824061308192406130820240613082124061308222406130823240613082424061308252406130826240613082724061308282406130830240617071224061707132406180837240618083824061808392406180840240618084124061808422406180843240618084424062407882406240789240624079024062407912406240792240624079424062407952406240796240624079724062407982406240799240624080024062408012406260658240626065924062606602406260661240626066224062606632406260664240626066524062606662406270521240627052224062705232406270524240627052524062705262406270527240627052824062705292406270530240627053124062705322406270533240702058824070205892407020593240702059424070206032407020662240702066324070206642407020665240702066624070206672407020668240702066924070206702407020671240702067224070206732407020674240702067524070206762407020677240702067824070206792407030183240703018424070301852407030186240703018724070301882407030189240703019024070302482407030249240703025024070807682407080769240708077024070807712407080773240708077424070807752407080776240708077824070807792407090613240709061424070906152407090616240709061724071006962407100697240710069924071007002407100702240710070324071007042407150254240715025624071502572407150258240715026024071502612407150262240715026424071502652407160650240716065124071606522407160653240716065424071606552407160656240716065724071606582407160659240716066024071705632407170564240717056624071705752407170831240717083224071708332407170954240717095524071709562407170957240717095824071709592407180707240718070824071807092407180710240718071124072206592407220660240722066124072206622407220663240722066424072206652407220666

What the firm is doing

Auris Health notified consignees via emailed "URGENT FIELD SAFETY NOTICE - DEVICE RECALL" letter dated 10/17/2025 on about 10/18/2025. Consignees were instructed to cease use of affected units immediately, forward the notification to any applicable personnel as well as customers if further distributed/transferred, and arrange for the return of all affected units. Consignees were also instructed to complete and return the Acknowledgement Form via email to MonarchSupport@its.jnj.com. Please return this form even if you no longer have or use the device subject to this notification. Please return any of the listed bronchoscopes in your possession to Auris Health, Inc. Please contact the MONARCH Support team at +1 (800) 434-0032 or via email at MonarchSupport@its.jnj.com for support in returning any impacted devices. If you have any questions regarding this letter or need support, please contact the MONARCH Support team at +1 (800) 434-0032 or via email at MonarchSupport@its.jnj.com. For Medical Information requests, please visit our website at https://www.jnjmedtech.com/mir.

DistributionShow details

Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA, MI, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, VA, VT, WA, WV.

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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