CLASS II ONGOING Device recall · Reported 18 Mar 2026 · FDA Enforcement Report

Clarity II Laser System recalled by Lutronic

Lutronic is recalling Clarity II Laser System, distributed nationwide in the US. The recall was initiated on 27 Jan 2026 and the FDA has classified it as Class II.

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Lot, batch or date codesModel No. 1110200210; UDI: 08809447653723; Serial No. C3023K024, C3022B006, C3025D028, C3022L031, C3024D027, C3022H015, C3024K033, C3019J018, C3024K030, C3025B076, C3023K043, C3021K002, C3025E050, C3025E035, C3022L010, C3023G009, C3023J037, C3021D021, C3020C010, C3019L007, C3025B011, C3025B012, C3022G011, C3022F020, C3025D076, C3024J038, C3025E041, C3021L005, C3025C022, C3024G026, C3023B044, C3021F012, C3024G008, C3024D025, C3025E065, C3024F030, C3022H021, C3022H022, C3025C029, C3023L034, C3023L070, C3023D060, C3024H029, C3025D094, C3023L043, C3022M010, C3023C008, C3025D085, C3022J035, C3022K009, C3023K035, C3025B071, C3021F001, C3023J006, C3022L026, C3022J033, C3023J004, C3024G004, C3022D023, C3025E028, C3021L031, C3023K048, C3025D080, C3019M006, C3022A003, C3023K027, C3021K020, C3022K023, C3025D035, C3023J029, C3022E030, C3021L007, C3025B078, C3023J041, C3023A020, C3025E038, C3023H019, C3025C034, C3024J041, C3025E047, C3025D097, C3022E026, C3024J089, C3025B033, C3023B002, C3023B040, C3023B018, C3022K007, C3024F012, C3022G015, C3022J024, C3025B118, C3024J088, C3023L010, C3022F014, C3022F015, C3024J078, C3023L041, C3020K009, C3019J007, C3020K012, C3023B035, C3024J046, C3025D040, C3024J047, C3020J012, C3024J091, C3025D039, C3024M058, C3020L006, C3023E026, C3023E027, C3022K020, C3023L027, C3020L008, C3022L040, C3024G014, C3023M020, C3025E091, C3022A032, C3022B012, C3025E095, C3025C019, C3025C020, C3025C017, C3025C018, C3024D002, C3024C017, C3022J011, C3020H003, C3023H016, C3024C013, C3022A009, C3022J030, C3021F013, C3023E029, C3021M005, C3025E027, C3022K008, C3023K046, C3023D015, C3024G022, C3025B003, C3025E073, C3023L012, C3024H016, C3024J043, C3021G022, C3019K005, C3023G031, C3023E037, C3025E033, C3023M024, C3025D105, C3023F021, C3025E060, C3024F013, C3022E029, C3024K051, C3024J086, C3025C035, C3023E024, C3024J045, C3023J042, C3025B028, C3023F025, C3023L035, C3023C013, C3023D049, C3023D048, C3021J003, C3023F015, C3025E034, C3023A019, C3020G002, C3023D041, C3023D045, C3025D099, C3023G013, C3023D018, C3024M055, C3023C012, C3023F022, C3025C026, C3022L038, C3024H031, C302J009, C3025E032, C3024K117, C3022K006, C3024G017, C3024J049, C3022F001, C3023J017, C3022J027, C3021A007, C3023A024, C3024H077, C3024K016, C3025B079, C3023D002, C3022A033, C3023F020, C3023F019, C3022L036, C3023M021, C3024G018, C3025D084, C3025E006, C3024H021, C3024J036, C3022H013, C3025B118, C3024M060, C3024J075, C3022F019, C3019M009, C3019K003, C3023L039, C3024H016, C3022M016, C3024K113, C3022J028, C3022L056, C3022H014, C3022C011, C3021K004, C3024H079, C3025B074, C3024K054, C3023K031, C3022H020, C3024H074, C3023K030, C3022B005, C3025D081, C3024G010, C3025E056, C3021D018, C3021L030, C3025E025, C3019M001, C3021J001, C3021M018, C3022K019, C3021L008, C3021G020, C3019K009, C3023E035, C3022J029, C3021A008, C3025D102, C3024K114, C3022E020, C3020L003, C3023L044, C3024J042, C3023E038, C3023L068, C3022M004, C3023E040, C3024D031, C3019M007, C3023K042, C3024J054, C3024K023, C3023C016, C3023C020, C3024K035, C3022A007, C3023D044, C3023B005, C3022C009, C3024J081, C3023L069, C3022L003, C3024H028, C3019K004, C3025D030, C3024H061, C3024C018, C3025E011, C3025E052, C3021M007, C3025E075, C3025D083, C3025E054, C3020C007, C3025D101, C3024J044, C3024H030, C3025D043, C3023J036, C3025B072, C3025D082, C3023H017, C3024D028, C3023D014, C3022F010, C3023A026, C3025D096, C3023L037, C3024E007, C3025B115, C3024K111, C3023J005, C3025B113, C3023J039, C3023J011, C3023D021, C3019K008, C3024H015, C3024J090, C3023E023, C3023D059, C3023K022, C3022F005, C3024H041, C3023C018, C3023A022, C3023L033, C3025B073, C3025D095, C3022L033, C3023J014, C3022J025, C3019L004, C3025B009, C3025E051, C3020G003, C3024E009, C3024H014, C3022F021, C3025B111, C3022J002, C3022L041, C3021K021, C3025E023, C3025E071, C3022L049, C3024C019, C3023L019, C3023K049, C3023C010, C3020J005, C3021M011, C3021K003, C3023H014, C3022M006, C3023A021, C3021M010, C3025E029, C3023D012, C3020G008, C3024G024, C3025D103, C3024D023, C3023L073, C3022D025, C3024H034, C3023C006, C3022L039, C3024K116, C3024H024, C3021D017, C3023B004, C3024H071, C3021J033, C3022H025, C3024H033, C3021H017, C3025D098, C3023K034, C3023G025, C3024J003, C3024K020, C3019M008, C3025B037, C3025B036, C3022E016, C3022M009, C3025E049, C3023G026, C3023D008, C3024F011, C3025E039, C3022F012, C3023B041, C3024K057, C3025D065, C3024H075, C3023B042, C3024D026, C3021F011, C3024J035, C3024K021, C3021F008, C3023L014, C3024H020, C3023G016, C3020G009, C3024E005, C3025D061, C3022L057, C3020J013, C2014K002, C3023E041, C3025E074, C3025D045, C3025D086, C3024K022, C3025E036, C3025D027, C3023C017, C3022A002, C3025D036, C3023D016, C3023F016, C3024G016, C3025E076, C3025B119, C3023K044, C3022L018, C3024H040, C3024K027, C3019L001, C3025E013, C3020J004, C3023B010, C3022E014, C3022J008, C3022E017, C3022A034, C3023J034, C3024K034, C3024H068, C3023J043, C3023L076, C3022H024, C3025C031, C3023A028, C3019J010, C3022J015, C3023D043, C3023D050, C3023B016, C3022L006, C3022L005, C3025E062, C3023G024, C3023K041, C3022K010, C3023H015, C3025D100, C3025B034, C3025B031, C3022G014, C3025E066, C3025E014, C3025C016, C3023G010, C3022L042, C3022L043, C3022L044, C3023L071, C3023G029, C3023L007, C3025E044, C3020L001, C3021M004, C3024C012, C3025D029, C3022L028, C3022L035, C3025E063, C3025E048, C3022H018, C3022H019, C3022K013, C3021F010, C3020J014, C3020K011, C3022M007, C3021D016, C3025E093, C3022M008, C3024D030, C3025D063, C3023E042, C3022E028, C3025D037, C3022L007, C3025E021, C3024K050, C3023K047, C3025E017, C3022M014, C3023K036, C3023K050, C3023J002, C3024F027, C3025C028, C3022A035, C3025E072, C3024K120, C3024H067, C3024H064, C3024H063, C3024H065, C3022C029, C3025E019, C3024K025, C3022J014, C3022L027, C3022F006, C3023A023, C3022A031, C3022D024, C3025E094, C3020J008, C3019H008, C3024H070, C3024H060, C3021D022, C3024J084, C3024J075, C3025D042, C3024K119, C3025E089, C3019H002, C3019J017, C3023B017, C3022L009, C3025E030, C3023H020, C3022M005, C3022K014, C3025E064, C3022A028, C3024H037, C3019L002, C3024H072, C3022H016, C3024G005, C3020L002, C3024J039, C3025B080, C3022L055, C3023L009, C3023F017, C3025E018, C3025E097, C3025E043, C3023L013, C3022F009, C3021G001, C3019L006, C3022F017, C3024J002, C3022H017, C3021D019, C3023D017, C3024K112, C3022L052, C3022C004, C3022K024, C3023L045, C3022L058, C3023E032, C3024G003, C3024J083, C3024H018, C3023G033, C3021M014, C3022M013, C3022E022, C3021F004, C3023H023, C3023L020, C3024K026, C3020L004, C3022F002, C3025D079, C3023L023, C3021H013, C3023F029, C3021K005, C3025D032, C3024K115, C3024G027, C3024H017, C3023J032, C3023J038, C3023E033, C3023D005, C3024F010, C3023L018, C3024F009, C3022C010, C3024D024, C3021K001, C3023B036, C3019J014, C3025C027, C3024J006, C3019J008, C3022F016, C3023D055, C3023E031, C3023E039, C3022H012, C3023D042, C3021M015, C3025B117, C3023B012, C3023L028, C3023J040, C3022L019, C3024J009, C3024J010, C3024K055, C3023L039, C3022E027, C3025C023, C3023B043, C3025D034, C3024J087, C3022G018, C3023J012, C3023M027, C3024G007, C3023D046, C3023K028, C3024J052, C3023C005, C3024J037, C3024J093, C3024J079, C3023M023, C3023B019, C3021F014, C3025E009, C3023D019, C3022E015, C3023G032, C3022C023, C3023C014, C3022M011, C3024G009, C3024J076, C3022M003, C3022B013, C3020J007, C3025D044, C3025E008, C3020K010, C3024C015, C3022F007, C3023L022, C3022J026, C3024D029, C3023L016, C3019M004, C3021L004, C3025E067, C3024M062, C3022E023, C3023B039, C3022J001, C3023J033, C3024G019, C3025E092, C3019K010, C3023L024, C3025C030, C3023L046, C3025E016, C3023K029, C3022L053, C3023K045, C3023C007, C3025C021, C3023C004, C3025E020, C3023K023, C3024D005, C3024D001, C3025E057, C3022L037, C3021F007, C3021M012, C3024H038, C3024D004, C3023L042, C3023M019, C3024G025, C3022F008, C3021M013, C3022A037, C3019L003, C3025E090, C3025D088, C3025E012, C3019M005, C3022G017, C3024H026, C3024M056, C3022A008, C3025E010, C3023L015, C3024H036, C3024H035, C3022C012, C3023L038, C3024J080, C3023K025, C3024K118, C3025B007, C3020H005, C3024H039, C3023E034, C3023E028, C3023B001, C3022E032, C3021J020, C3025E042, C3025C032, C3024G023, C3022H026, C3024K028, C3023B037, C3023J009, C3025C025, C3021G021, C3021M003, C3023K038, C3023K033, C3025B035, C3024M061, C3023M026, C3024G013, C3024J092, C3025E096, C3022F019, C3019M003, C3022M015, C3022L013, C3023J016, C3025B077, C3024K019, C3021M008, C3024J082, C3024G021, C3025B029, C3021F002, C3019J015, C3024K024, C3022L050, C3024K053, C3025D033, C3024H019, C3023C015, C3022M012, C3025B114, C3020G004, C3024J051, C3022F003, C3022L017, C3023J010, C3025E040, C3020J009, C3023B038, C3022J032, C3021K019, C3024C014, C3024H025, C3024H022, C3022L004, C3021H015, C3022L011, C3022L034, C3022C024, C3023D020, C3023C022, C3025D062, C3022J022, C3025D092, C3022A004, C3022B010, C3022J003, C3025D041, C3022L054, C3024J007, C3024H069, C3020J003, C3025B110, C3022A010, C3022A005, C3023L021, C3024G006, C3023K032, C3022J031, C3022G013, C3025B116, C3021L033, C3021L032, C3022L021, C3022C006, C3022H023, C3020C008, C3025E068, C3023L006, C3021F006, C3022J023, C3024H032, C3025E005, C3023D054, C3019J016, C3022C027, C3024D003, C3022K025, C3022J007, C3025D093, C3025D078, C3024H042, C3024H078, C3023L040, C3022L008, C3023G012, C3023L077, C3025E098, C3025D026, C3024M054, C3023J008, C3023L031, C3023G017, C3024J048, C3024K049, C3023J003, C3024H012, C3024H013, C3023J030, C3021K018, C3023C021, C3021M006, C3025B004, C3025E015, C3024J077, C3019J009, C3023L032, C3024J008, C3019L005, C3022B008, C3025E055, C3024J074, C3023B013, C3022E021, C3023D004, C3022B014, C3021F005, C3020G005, C3022J034, C3025C033, C3025B030, C3024C011, C3023L025, C3023G018, C3025B075, C3024C016, C3022L051, C3022C005, C3025E053, C3022E025, C3021J019, C3024K048, C3025D090, C3025D064, C3025D091, C3022K021, C3021J031, C3020J010, C3024H062, C3021J002, C3025E007, C3023B020, C3024J040, C3021H012, C3023E030, C3023J031, C3023G011, C3024K031, C3022L032, C3023D009, C3022G016, C3022J004, C3019M010, C3020H004, C3024H023, C3019M002, C3025D031, C3022C026, C3024K017, C3021M020, C3022K017, C3023D013, C3024G015, C3023B021, C3022C025, C3022K022, C3023E025, C3024H073, C3025B112, C3022A001, C3023D057, C3021J021, C3023D047, C3024G020, C3022G019, C3025B006, C3024J085, C3022C008, C3023C019, C3022C003, C3021G004, C3023D003, C3021G003, C3022F004, C3024J053, C3022J013, C3022L045, C3021M009, C3021G005, C3024M057, C3024G012, C3024F028, C3021J004, C3020J015, C3022E018, C3020J011, C3021K022, C3022C007, C3025D077, C3023J015, C3023L017, C3023K039, C3022A006, C3021A006, C3022B009, C3024K018, C3022E031, C3021J005, C3020K008, C3023F018, C3021D001, C3023L075, C3022E033, C3021M002, C3021M001, C3021H014, C3025D087, C3025E070, C3023H018, C3024K052, C3024K032, C3021L002, C3024H076, C3021H016, C3022A029, C3022B007, C3021F015, C3021M017, C3021D020, C3021D023, C3022L029, C3022L030, C3022J005, C3023G015, C3025B008, C3023D010, C3020G006, C3023G027, C3024J005, C3025E058, C3021F003, C3025E059, C3022F018, C3023D051, C3023F026, C3020L007, C3023K040, C3025B032, C3022M002, C3023B024, C3021G002, C3023F023, C3022K018, C3022J006, C3022G010, C3023K037, C3023C003, C3023J035, C3024C020, C3021L003, C3025E061, C3023L074, C3023B003, C3022L015, C3022E019, C3023K021, C3022L002, C3024F029, C3023F027, C3023F028, C3025B005, C3022J021, C3025E024, C3023F024, C3024D022, C3024J004, C3020H001, C3023G030, C3025E037, C3023D052, C3021M021, C3022F013, C3025E031, C3025E022, C3025E026, C3023L008, C3022L020, C3022K011, C3025D104, C3024J001, C3023G028, C3024K029, C3023K026, C3024G011, C3023B022, C3025B010, C3023A025, C3023M025, C3024J050, C3025D038, C3019K001, C3022A030, C3021L006, C3022C028, C3024M063, C3020L005, C3021D015, C3021L029, C3025D089, C3021F009, C3023M022, C3019K007, C3023B011.

Quantity recalled1,525 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1558-2026
FDA event ID: 98372
Recalling firm: Lutronic, Goyang, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 27 Jan 2026
FDA classified: 12 Mar 2026
Reported: 18 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Jan 2026	Recall initiated by company
12 Mar 2026	Classified by FDA	+44 days
18 Mar 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reports of devices sparking/popping and potentially burning patients.

Product as listed by the FDA

CLARITY II Laser System; Model No. 1110200210.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

Nationwide

Questions about this recall

Is Clarity II Laser System recalled?

Yes. Lutronic recalled Clarity II Laser System on 27 Jan 2026. The recall is Class II and its status is Ongoing. Recall number Z-1558-2026.

Why was it recalled?

Reports of devices sparking/popping and potentially burning patients.

Which lots are affected?

Model No. 1110200210; UDI: 08809447653723; Serial No. C3023K024, C3022B006, C3025D028, C3022L031, C3024D027, C3022H015, C3024K033, C3019J018, C3024K030, C3025B076, C3023K043, C3021K002, C3025E050, C3025E035, C3022L010, C3023G009, C3023J037, C3021D021, C3020C010, C3019L007, C3025B011, C3025B012, C3022G011, C3022F020, C3025D076, C3024J038, C3025E041, C3021L005, C3025C022, C3024G026, C3023B044, C3021F012, C3024G008, C3024D025, C3025E065, C3024F030, C3022H021, C3022H022, C3025C029, C3023L034, C3023L070, C3023D060, C3024H029, C3025D094, C3023L043, C3022M010, C3023C008, C3025D085, C3022J035, C3022K009, C3023K035, C3025B071, C3021F001, C3023J006, C3022L026, C3022J033, C3023J004, C3024G004, C3022D023, C3025E028, C3021L031, C3023K048, C3025D080, C3019M006, C3022A003, C3023K027, C3021K020, C3022K023, C3025D035, C3023J029, C3022E030, C3021L007, C3025B078, C3023J041, C3023A020, C3025E038, C3023H019, C3025C034, C3024J041, C3025E047, C3025D097, C3022E026, C3024J089, C3025B033, C3023B002, C3023B040, C3023B018, C3022K007, C3024F012, C3022G015, C3022J024, C3025B118, C3024J088, C3023L010, C3022F014, C3022F015, C3024J078, C3023L041, C3020K009, C3019J007, C3020K012, C3023B035, C3024J046, C3025D040, C3024J047, C3020J012, C3024J091, C3025D039, C3024M058, C3020L006, C3023E026, C3023E027, C3022K020, C3023L027, C3020L008, C3022L040, C3024G014, C3023M020, C3025E091, C3022A032, C3022B012, C3025E095, C3025C019, C3025C020, C3025C017, C3025C018, C3024D002, C3024C017, C3022J011, C3020H003, C3023H016, C3024C013, C3022A009, C3022J030, C3021F013, C3023E029, C3021M005, C3025E027, C3022K008, C3023K046, C3023D015, C3024G022, C3025B003, C3025E073, C3023L012, C3024H016, C3024J043, C3021G022, C3019K005, C3023G031, C3023E037, C3025E033, C3023M024, C3025D105, C3023F021, C3025E060, C3024F013, C3022E029, C3024K051, C3024J086, C3025C035, C3023E024, C3024J045, C3023J042, C3025B028, C3023F025, C3023L035, C3023C013, C3023D049, C3023D048, C3021J003, C3023F015, C3025E034, C3023A019, C3020G002, C3023D041, C3023D045, C3025D099, C3023G013, C3023D018, C3024M055, C3023C012, C3023F022, C3025C026, C3022L038, C3024H031, C302J009, C3025E032, C3024K117, C3022K006, C3024G017, C3024J049, C3022F001, C3023J017, C3022J027, C3021A007, C3023A024, C3024H077, C3024K016, C3025B079, C3023D002, C3022A033, C3023F020, C3023F019, C3022L036, C3023M021, C3024G018, C3025D084, C3025E006, C3024H021, C3024J036, C3022H013, C3025B118, C3024M060, C3024J075, C3022F019, C3019M009, C3019K003, C3023L039, C3024H016, C3022M016, C3024K113, C3022J028, C3022L056, C3022H014, C3022C011, C3021K004, C3024H079, C3025B074, C3024K054, C3023K031, C3022H020, C3024H074, C3023K030, C3022B005, C3025D081, C3024G010, C3025E056, C3021D018, C3021L030, C3025E025, C3019M001, C3021J001, C3021M018, C3022K019, C3021L008, C3021G020, C3019K009, C3023E035, C3022J029, C3021A008, C3025D102, C3024K114, C3022E020, C3020L003, C3023L044, C3024J042, C3023E038, C3023L068, C3022M004, C3023E040, C3024D031, C3019M007, C3023K042, C3024J054, C3024K023, C3023C016, C3023C020, C3024K035, C3022A007, C3023D044, C3023B005, C3022C009, C3024J081, C3023L069, C3022L003, C3024H028, C3019K004, C3025D030, C3024H061, C3024C018, C3025E011, C3025E052, C3021M007, C3025E075, C3025D083, C3025E054, C3020C007, C3025D101, C3024J044, C3024H030, C3025D043, C3023J036, C3025B072, C3025D082, C3023H017, C3024D028, C3023D014, C3022F010, C3023A026, C3025D096, C3023L037, C3024E007, C3025B115, C3024K111, C3023J005, C3025B113, C3023J039, C3023J011, C3023D021, C3019K008, C3024H015, C3024J090, C3023E023, C3023D059, C3023K022, C3022F005, C3024H041, C3023C018, C3023A022, C3023L033, C3025B073, C3025D095, C3022L033, C3023J014, C3022J025, C3019L004, C3025B009, C3025E051, C3020G003, C3024E009, C3024H014, C3022F021, C3025B111, C3022J002, C3022L041, C3021K021, C3025E023, C3025E071, C3022L049, C3024C019, C3023L019, C3023K049, C3023C010, C3020J005, C3021M011, C3021K003, C3023H014, C3022M006, C3023A021, C3021M010, C3025E029, C3023D012, C3020G008, C3024G024, C3025D103, C3024D023, C3023L073, C3022D025, C3024H034, C3023C006, C3022L039, C3024K116, C3024H024, C3021D017, C3023B004, C3024H071, C3021J033, C3022H025, C3024H033, C3021H017, C3025D098, C3023K034, C3023G025, C3024J003, C3024K020, C3019M008, C3025B037, C3025B036, C3022E016, C3022M009, C3025E049, C3023G026, C3023D008, C3024F011, C3025E039, C3022F012, C3023B041, C3024K057, C3025D065, C3024H075, C3023B042, C3024D026, C3021F011, C3024J035, C3024K021, C3021F008, C3023L014, C3024H020, C3023G016, C3020G009, C3024E005, C3025D061, C3022L057, C3020J013, C2014K002, C3023E041, C3025E074, C3025D045, C3025D086, C3024K022, C3025E036, C3025D027, C3023C017, C3022A002, C3025D036, C3023D016, C3023F016, C3024G016, C3025E076, C3025B119, C3023K044, C3022L018, C3024H040, C3024K027, C3019L001, C3025E013, C3020J004, C3023B010, C3022E014, C3022J008, C3022E017, C3022A034, C3023J034, C3024K034, C3024H068, C3023J043, C3023L076, C3022H024, C3025C031, C3023A028, C3019J010, C3022J015, C3023D043, C3023D050, C3023B016, C3022L006, C3022L005, C3025E062, C3023G024, C3023K041, C3022K010, C3023H015, C3025D100, C3025B034, C3025B031, C3022G014, C3025E066, C3025E014, C3025C016, C3023G010, C3022L042, C3022L043, C3022L044, C3023L071, C3023G029, C3023L007, C3025E044, C3020L001, C3021M004, C3024C012, C3025D029, C3022L028, C3022L035, C3025E063, C3025E048, C3022H018, C3022H019, C3022K013, C3021F010, C3020J014, C3020K011, C3022M007, C3021D016, C3025E093, C3022M008, C3024D030, C3025D063, C3023E042, C3022E028, C3025D037, C3022L007, C3025E021, C3024K050, C3023K047, C3025E017, C3022M014, C3023K036, C3023K050, C3023J002, C3024F027, C3025C028, C3022A035, C3025E072, C3024K120, C3024H067, C3024H064, C3024H063, C3024H065, C3022C029, C3025E019, C3024K025, C3022J014, C3022L027, C3022F006, C3023A023, C3022A031, C3022D024, C3025E094, C3020J008, C3019H008, C3024H070, C3024H060, C3021D022, C3024J084, C3024J075, C3025D042, C3024K119, C3025E089, C3019H002, C3019J017, C3023B017, C3022L009, C3025E030, C3023H020, C3022M005, C3022K014, C3025E064, C3022A028, C3024H037, C3019L002, C3024H072, C3022H016, C3024G005, C3020L002, C3024J039, C3025B080, C3022L055, C3023L009, C3023F017, C3025E018, C3025E097, C3025E043, C3023L013, C3022F009, C3021G001, C3019L006, C3022F017, C3024J002, C3022H017, C3021D019, C3023D017, C3024K112, C3022L052, C3022C004, C3022K024, C3023L045, C3022L058, C3023E032, C3024G003, C3024J083, C3024H018, C3023G033, C3021M014, C3022M013, C3022E022, C3021F004, C3023H023, C3023L020, C3024K026, C3020L004, C3022F002, C3025D079, C3023L023, C3021H013, C3023F029, C3021K005, C3025D032, C3024K115, C3024G027, C3024H017, C3023J032, C3023J038, C3023E033, C3023D005, C3024F010, C3023L018, C3024F009, C3022C010, C3024D024, C3021K001, C3023B036, C3019J014, C3025C027, C3024J006, C3019J008, C3022F016, C3023D055, C3023E031, C3023E039, C3022H012, C3023D042, C3021M015, C3025B117, C3023B012, C3023L028, C3023J040, C3022L019, C3024J009, C3024J010, C3024K055, C3023L039, C3022E027, C3025C023, C3023B043, C3025D034, C3024J087, C3022G018, C3023J012, C3023M027, C3024G007, C3023D046, C3023K028, C3024J052, C3023C005, C3024J037, C3024J093, C3024J079, C3023M023, C3023B019, C3021F014, C3025E009, C3023D019, C3022E015, C3023G032, C3022C023, C3023C014, C3022M011, C3024G009, C3024J076, C3022M003, C3022B013, C3020J007, C3025D044, C3025E008, C3020K010, C3024C015, C3022F007, C3023L022, C3022J026, C3024D029, C3023L016, C3019M004, C3021L004, C3025E067, C3024M062, C3022E023, C3023B039, C3022J001, C3023J033, C3024G019, C3025E092, C3019K010, C3023L024, C3025C030, C3023L046, C3025E016, C3023K029, C3022L053, C3023K045, C3023C007, C3025C021, C3023C004, C3025E020, C3023K023, C3024D005, C3024D001, C3025E057, C3022L037, C3021F007, C3021M012, C3024H038, C3024D004, C3023L042, C3023M019, C3024G025, C3022F008, C3021M013, C3022A037, C3019L003, C3025E090, C3025D088, C3025E012, C3019M005, C3022G017, C3024H026, C3024M056, C3022A008, C3025E010, C3023L015, C3024H036, C3024H035, C3022C012, C3023L038, C3024J080, C3023K025, C3024K118, C3025B007, C3020H005, C3024H039, C3023E034, C3023E028, C3023B001, C3022E032, C3021J020, C3025E042, C3025C032, C3024G023, C3022H026, C3024K028, C3023B037, C3023J009, C3025C025, C3021G021, C3021M003, C3023K038, C3023K033, C3025B035, C3024M061, C3023M026, C3024G013, C3024J092, C3025E096, C3022F019, C3019M003, C3022M015, C3022L013, C3023J016, C3025B077, C3024K019, C3021M008, C3024J082, C3024G021, C3025B029, C3021F002, C3019J015, C3024K024, C3022L050, C3024K053, C3025D033, C3024H019, C3023C015, C3022M012, C3025B114, C3020G004, C3024J051, C3022F003, C3022L017, C3023J010, C3025E040, C3020J009, C3023B038, C3022J032, C3021K019, C3024C014, C3024H025, C3024H022, C3022L004, C3021H015, C3022L011, C3022L034, C3022C024, C3023D020, C3023C022, C3025D062, C3022J022, C3025D092, C3022A004, C3022B010, C3022J003, C3025D041, C3022L054, C3024J007, C3024H069, C3020J003, C3025B110, C3022A010, C3022A005, C3023L021, C3024G006, C3023K032, C3022J031, C3022G013, C3025B116, C3021L033, C3021L032, C3022L021, C3022C006, C3022H023, C3020C008, C3025E068, C3023L006, C3021F006, C3022J023, C3024H032, C3025E005, C3023D054, C3019J016, C3022C027, C3024D003, C3022K025, C3022J007, C3025D093, C3025D078, C3024H042, C3024H078, C3023L040, C3022L008, C3023G012, C3023L077, C3025E098, C3025D026, C3024M054, C3023J008, C3023L031, C3023G017, C3024J048, C3024K049, C3023J003, C3024H012, C3024H013, C3023J030, C3021K018, C3023C021, C3021M006, C3025B004, C3025E015, C3024J077, C3019J009, C3023L032, C3024J008, C3019L005, C3022B008, C3025E055, C3024J074, C3023B013, C3022E021, C3023D004, C3022B014, C3021F005, C3020G005, C3022J034, C3025C033, C3025B030, C3024C011, C3023L025, C3023G018, C3025B075, C3024C016, C3022L051, C3022C005, C3025E053, C3022E025, C3021J019, C3024K048, C3025D090, C3025D064, C3025D091, C3022K021, C3021J031, C3020J010, C3024H062, C3021J002, C3025E007, C3023B020, C3024J040, C3021H012, C3023E030, C3023J031, C3023G011, C3024K031, C3022L032, C3023D009, C3022G016, C3022J004, C3019M010, C3020H004, C3024H023, C3019M002, C3025D031, C3022C026, C3024K017, C3021M020, C3022K017, C3023D013, C3024G015, C3023B021, C3022C025, C3022K022, C3023E025, C3024H073, C3025B112, C3022A001, C3023D057, C3021J021, C3023D047, C3024G020, C3022G019, C3025B006, C3024J085, C3022C008, C3023C019, C3022C003, C3021G004, C3023D003, C3021G003, C3022F004, C3024J053, C3022J013, C3022L045, C3021M009, C3021G005, C3024M057, C3024G012, C3024F028, C3021J004, C3020J015, C3022E018, C3020J011, C3021K022, C3022C007, C3025D077, C3023J015, C3023L017, C3023K039, C3022A006, C3021A006, C3022B009, C3024K018, C3022E031, C3021J005, C3020K008, C3023F018, C3021D001, C3023L075, C3022E033, C3021M002, C3021M001, C3021H014, C3025D087, C3025E070, C3023H018, C3024K052, C3024K032, C3021L002, C3024H076, C3021H016, C3022A029, C3022B007, C3021F015, C3021M017, C3021D020, C3021D023, C3022L029, C3022L030, C3022J005, C3023G015, C3025B008, C3023D010, C3020G006, C3023G027, C3024J005, C3025E058, C3021F003, C3025E059, C3022F018, C3023D051, C3023F026, C3020L007, C3023K040, C3025B032, C3022M002, C3023B024, C3021G002, C3023F023, C3022K018, C3022J006, C3022G010, C3023K037, C3023C003, C3023J035, C3024C020, C3021L003, C3025E061, C3023L074, C3023B003, C3022L015, C3022E019, C3023K021, C3022L002, C3024F029, C3023F027, C3023F028, C3025B005, C3022J021, C3025E024, C3023F024, C3024D022, C3024J004, C3020H001, C3023G030, C3025E037, C3023D052, C3021M021, C3022F013, C3025E031, C3025E022, C3025E026, C3023L008, C3022L020, C3022K011, C3025D104, C3024J001, C3023G028, C3024K029, C3023K026, C3024G011, C3023B022, C3025B010, C3023A025, C3023M025, C3024J050, C3025D038, C3019K001, C3022A030, C3021L006, C3022C028, C3024M063, C3020L005, C3021D015, C3021L029, C3025D089, C3021F009, C3023M022, C3019K007, C3023B011.

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Lutronic

All 3

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	DermaV Laser System recalled by Lutronic	Lutronic	Other	Nationwide
22 Oct 2025Device	CLASS II	Xerf Effector Electrosurgical unit recalled by Lutronic	Lutronic	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide