--- title: "CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 2... — FDA record Z-0581-2026 | Is It on Recall" description: "XXX" url: https://isitonrecall.com/recall/fda-device-z-0581-2026-constellation-ultravit-10k-and-constellation-hypervit-20k-description-ref-25-totalplus-cp-pak-20k-cp/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8... — FDA record Z-0581-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Sep 15, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452; 25+TTLPL VPK 20000CPM BEV VAL/ 8065753106; 27+TTLPL VPK 20000CPM BEV VL/ 8065753109; HYPERVIT 25+BEV 20000 CPM/ 8065830026; HYPERVIT 27+BEV 20000 CPM/ 8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077; 25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27; 23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09; AUS-25GA VIT RET BRISBANE WATERS/ 12641-13; AUS-25GA VIT RET BRISBANE WATERS/ 12641-14; AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16; 23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08; 25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10; 23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13; 25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15; VITRECTOMY 25G V A HOSPITAL/ 14129-10; J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12; CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07; CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08; CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16; CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07; CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11; CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09; CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11; CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06; CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07; CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08; CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09; CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07; CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08; CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06; CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07; CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09; CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08; 25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13; CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14; CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07; C... - **Reason**: XXX - **Classification**: Class II - **Recalling firm**: Alcon Research LLC - **Quantity**: 28323 - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0581-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0581-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | UDI-DI/REF: 5414660389996/C26992-01; 5414660396666/C23069-05; 5414660396697/C23125-04; 5414660400332/C17655-06; 5414660400356/C17731-06; 5414660401254/C27454-02; 5414660401285/C27450-02; 5414660401292/C27449-02; 5414660405221/C27453-03; 5414660409380/C27818-04; 5414660409700/C27864-01 5414660410225/C27876-01; 5414660413356/C28044-05; 5414660413691/C19139-07; 5414660417668/C25243-02; 5414660418221/C27440-02; 5414660418238/C27441-03, 5414660418245/C27442-02; 5414660418252/C27443-02; 5414660418269/C27444-02; 5414660418276/C27445-02; 5414660420620/C28328-02; 5414660421061/C21524-03; 5414660421078/C18093-04; 5414660421993/C27789-08; 5414660423874/C27007-03; 5414660427759/C19940-07; 5414660429029/C26049-02; 5414660434382/C29260-01; 5414660434412/C26740-08; 5414660434429/C26739-09; 5414660434443/C21175-07; 5414660434450/C28294-04; 5414660434542/C24151-06; 5414660434559/C29080-03; 5414660434580/C28885-03; 5414660434597/C28884-03; 5414660434603/C28883-05; 5414660434658/C27558-03; 5414660434665/C20382-07; 5414660434733/C29015-03; 5414660434870/C24900-04; 5414660434931/C27086-04; 5414660434948/C27091-05; 5414660435150/C28673-03; 5414660435167/C28738-03; 5414660435228/C29261-01/ 5414660435617/C26731-04; 5414660435648/C22375-13; 5414660435662/C26854-09; 5414660436171/C29271-01; 5414660436263/C29272-01; 5414660436539/C28996-04; 5414660436591/C25163-05; 5414660436607/C22118-04; 5414660436744/C23137-11; 5414660436768/C25162-05; 5414660436775/C26763-04; 5414660444206/C28786-01; 5414660446538/C28835-01; 5414660447726/C28795-02; 5414660448983/C28005-03; 5414660448990/C28024-04; 5414660450610/C28908-01; 5414660450948/C27548-02; 5414660450955/C27549-02; 5414660450962/C27550-02; 5414660453888/C28686-03; 5414660454977/C24333-05; 5414660456223/C28950-01; 5414660457237/C19081-10, C19081-10-01; 5414660457985/C26224-06; 5414660458975/C21162-07; 5414660459019/C24998-04; 5414660459439/C25768-03; 5414660461555/C19947-10; 5414660462576/C22297-04; 5414660462880/C28595-02; 5414660462903/C28596-02; 5414660462910/C28597-02; 5414660462934/C28977-01; 5414660463344/C22052-05; 5414660463399/C26609-05; 5414660463795/C27623-02; 5414660463801/C27624-02; 5414660463825/C27626-02; 5414660463832/C27627-02; 5414660464082/C22117-03; 5414660468615/C28999-01; 5414660469711/C28001-02 5414660469728/C28002-02; 5414660469827/C27999-08; 5414660470335/C27657-04-01; 5414660471752/C26040-04; 5414660471790/C28003-02; 5414660473756/C27328-04; 5414660474968/C28765-02; 5414660475941/C24814-05; 5414660476436/C25201-09; 5414660476511/C28707-03; 5414660476986/C28291-07; 5414660477532/C24780-08; 5414660478423/C28854-03; 5414660479093/C29031-01; 5414660481874/C29033-01; 5414660481911/C29029-01; 5414660481928/C29030-01; 5414660481935/C29034-01; 5414660484073/C20919-08; 5414660484264/C20349-06; 5414660484851/C22527-06; 5414660484868/C22554-08; 5414660485605/C23537-05; 5414660485636/C23536-04; 5414660485988/C24281-03; 5414660486442/C25025-04; 5414660487760/C26041-06; 5414660488101/C27320-02; 5414660488767/C27693-02; 5414660488774/C27694-02; 5414660488804/C27658-02; 5414660489818/C19154-10; 5414660490128/C25225-09; 5414660490395/C25959-04; 5414660491682/C25957-03; 5414660491699/C25958-03; 5414660494720/C29110-01; 5414660496755/C26228-04; 5414660497172/C23619-09; 5414660497219/C26097-04; 5414660497820/C14928-07; 5414660497844/C23093-07; 5414660497868/C29014-03; 5414660498384/C26075-04; 5414660499725/C26610-06; 5414660499787/C27764-03; 5414660501381/C27228-03; 5414660501398/C27655-05; 5414660501459/C28256-07; 5414660502661/C28764-02; 5414660503286/C20781-07; 5414660503620/C27756-05; 5414660503668/C27763-02; 5414660504641/C24680-06; 5414660504658/C24681-07; 5414660505006/C29116-02; 5414660505013/C29117-02; 5414660505112/C28952-05; 5414660505129/C28953-05; 5414660505266/C23620-08; 5414660505655/C20782-07; 5414660505716/C28004-02; 5414660505853/C24442-08; 5414660506423/C27998-03; 5414660506454/C25919-10; 5414660506508/C24133-14; 5414660506522/C28894-02; 5414660506560/C23790-13; 5414660506836/C20681-11; 5414660506942/C20682-10; 5414660506959/C21121-11; 5414660507048/C22061-12; 5414660507079/C22065-07; 5414660507215/C25858-10; 5414660507697/C28370-10; 5414660507703/C28373-04; 5414660507895/C25200-10; 5414660508335/C26614-04; 5414660508342/C26615-04; 5414660508359/C26617-04; 5414660508366/C26619-04; 5414660508427/C24959-07; 5414660508465/C29182-01; 5414660508489/C29180-01; 5414660509554/C28382-06; 5414660509851/C29200-01; 5414660509936/C25139-10; 5414660509967/C25138-11; 5414660510598/C25050-06; 5414660510604/C25435-09; 5414660510659/C28094-04; 5414660510703/C28984-02; 5414660510796/C25047-05; 5414660510970/C27928-06; 5414660510987/C27961-09; 5414660511083/C28112-04; 5414660511106/C28100-04; 5414660511151/C26906-04; 5414660511168/C26907-04; 5414660511205/C24570-04; 5414660511335/C27396-04; 5414660511359/C25531-11; 5414660511489/C24696-05; 5414660511618/C27551-03; 5414660511687/C26019-09; 5414660511731/C26489-03; 5414660511748/C26490-04; 5414660511823/C26769-06; 5414660511908/C27552-04; 5414660512059/C28837-04; 5414660512158/C28179-05; 5414660512172/C29139-02; 5414660512219/C28233-04; 5414660512226/C28975-02; 5414660512240/C27606-03; 5414660512257/C27607-03; 5414660512349/C28652-03; 5414660512370/C24985-06; 5414660512448/C27395-04; 5414660512530/C24978-05; 5414660512547/C25295-08; 5414660512585/C25296-05; 5414660512592/C25297-06; 5414660512615/C27610-04; 5414660512622/C27611-03; 5414660512639/C28689-04; 5414660512653/C28690-03; 5414660512660/C19291-10; 5414660512677/C27697-02; 5414660512684/C27702-04; 5414660512752/C27962-08; 5414660512769/C28077-03; 5414660512790/C28265-07; 5414660512813/C24602-08; 5414660512837/C17778-13; 5414660512851/C26239-06; 5414660512868/C28282-05; 5414660512912/C27993-04; 5414660512950/C28074-05; 5414660513155/C22383-05; 5414660513179/C27528-02; 5414660513216/C29134-02; 5414660513261/C27527-02; 5414660513322/C24935-15; 5414660513360/C22382-06; 5414660513575/C20591-12; 5414660513766/C28680-03; 5414660513810/C24933-11; 5414660513827/C24934-12; 5414660513889/C20592-11; 5414660513902/C27188-03; 5414660513964/C17271-07; 5414660514077/C28099-04; 5414660514107/C28178-05; 5414660514213/C24153-05; 5414660514572/C29078-03; 5414660514589/C29079-03; 5414660514749/C28954-06; 5414660514831/C29210-01; 5414660514992/C28262-03; 5414660515029/C20678-09; 5414660515098/C17593-14; 5414660515166/C28086-04; 5414660515456/C24258-08; 5414660515609/C27813-09; 5414660515685/C28283-05; 5414660515760/C27267-06; 5414660515814/C27753-03; 5414660515951/C28231-03; 5414660515975/C25436-03; 5414660515982/C27019-03; 5414660516019/C27020-04; 5414660516026/C27733-06; 5414660516118/C25909-05; 5414660516149/C28529-04, C28482-08-01; 5414660516170/C28985-02; 5414660516279/C29124-02; 5414660516286/C29130-02; 5414660516309/C29129-02; 5414660516330/C28096-03; 5414660516347/C27022-04; 5414660516545/C25994-09; 5414660516583/C27021-03; 5414660516590/C27023-03; 5414660516606/C27024-05; 5414660516644/C27908-03; 5414660516651/C28234-04; 5414660516668/C28335-01; 5414660516675/C28337-02; 5414660516903/C28528-03; 5414660516941/C28969-03; 5414660516965/C29086-03; 5414660516996/C29125-02; 5414660517146/C25323-04; 5414660517153/C29020-03; 5414660517221/C27793-02; 5414660517238/C29215-01; 5414660517368/C28620-05-01, C28670-03; 5414660517443/C26416-04; 5414660517450/C27303-04; 5414660517504/C26186-07; 5414660517511/C26231-07; 5414660517528/C26232-08; 5414660517689/C26189-07; 5414660517696/C26234-07; 5414660517726/C25908-04; 5414660517740/C28978-02; 5414660517757/C29216-01; 5414660518143/C22879-09; 5414660518150/C29217-02; 5414660518181/C24507-10; 5414660518204/C24501-11; 5414660518280/C24136-08; 5414660518303/C26895-06; 5414660518471/C28624-05; 5414660518679/C26229-03; 5414660518884/C22186-06; 5414660518907/C25088-05; 5414660519157/C27726-04; 5414660519164/C27732-06; 5414660519195/C29224-01; 5414660519744/C28891-05; 5414660519782/C29226-01; 5414660519799/C29227-01; 5414660519973/C29138-03; 5414660520221/C22778-04; 5414660520245/C22777-05; 5414660520405/C24966-08; 5414660520412/C25132-07; 5414660520443/C25227-07; 5414660520535/C29006-03; 5414660520566/C27496-04; 5414660520603/C22544-09; 5414660520634/C22541-10; 5414660520641/C22543-09; 5414660520672/C25663-07; 5414660520764/C22540-09; 5414660520795/C29239-01; 5414660520825/C29241-01; 5414660521051/C29111-02; 5414660521167/C29037-05; 5414660521273/C27769-03; 5414660521310/C27787-07; 5414660521341/C28115-04; 5414660521358/C28097-03; 5414660521389/C29238-01; 5414660521792/C22385-10; 5414660521921/C28993-03; 5414660521938/C28997-03; 5414660521945/C23233-06; 5414660521952/C26667-05; 5414660522034/C22087-07, C22087-07-01; 5414660522065/C21792-08; 5414660522294/C29016-05; 5414660522324/C22086-07, C22086-07-01; 5414660522393/C23735-09; 5414660522409/C23739-09; 5414660522515/C25386-05; 5414660522751/C28470-03; 5414660522898/C25372-06; 5414660522904/C25373-06; 5414660522911/C25374-06; 5414660522942/C16966-14, C16966-14-01, 5414660522959/C16967-13, C16967-13-01; 5414660523147/C25322-06 5414660523338/C28462-03, C28429-03; 5414660523413/C21304-11, C21304-11-01; 5414660523635/C29305-01; 5414660523666/C25031-06; 5414660523673/C25065-04; 5414660523703/C27657-04; 5414660523819/C28026-02; 5414660523833/C28042-05; 5414660523925/C28034-05; 5414660524007/C25064-05, C25064-05-01; 5414660524021/C20486-16; 5414660524038/C20492-15; 5414660524069/C29307-01; 5414660524151/C29201-02; 5414660524175/C29200-02; 5414660524243/C20578-08, C20578-08-01; 5414660524274/C21958-08, C21958-08-01; 5414660524342/C24896-08; 5414660524359/C21873-11; 5414660524366/C21876-11; 5414660524373/C22248-06; 5414660524380/C28829-03; 5414660524397/C28830-03; 5414660524403/C17970-14; 5414660524427/C24895-08; 5414660524489/C28339-02; 5414660524496/C28356-03; 5414660524700/C29221-02; 5414660524762/C25607-05; 5414660524786/C29314-01; 5414660524793/C28769-03; 5414660524809/C28766-03; 5414660524830/C25367-06; 5414660524908/C28251-05; 5414660524953/C25366-06; 5414660525134/C27319-02; 5414660525240/C29322-01; 5414660525257/C29323-01; 5414660525264/C29324-01; 5414660525400/C28254-07; 5414660525424/C26042-05; 5414660525479/C25321-08; 5414660525639/C24090-07; 5414660525653/C24088-12; 5414660525677/C24089-12; 5414660525820/C28250-05; 5414660525837/C28823-07; 5414660525967/C28236-03; 5414660526285/C26376-05; 5414660526315/C27278-06; 5414660526360/C26375-05; 5414660526384/C19283-09; 5414660526452/C28803-06; 5414660526490/C28801-06; 5414660526506/C28802-06; 5414660526537/C28800-06; 5414660526575/C29341-01; 5414660526612/C28047-01; 5414660526650/C26379-05;; 5414660526797/C24127-09, C24127-09-01; 5414660526841/C22954-10; 5414660526933/C22951-10, C22951-10-01; 5414660527015/C27710-08; 5414660527022/C27711-04; 5414660527039/C27712-03; 5414660527053/C28866-02; 5414660527244/C28482-07; 5414660527343/C23842-11, C23842-11-01; 5414660527350/C19886-13; 5414660527367/C22172-15-01, C22171-16-01; 5414660527398/C22172-15, C22171-16, C22145-07; 5414660527473/C17890-12; 5414660527503/C23816-05; 5414660527510/C25568-03; 5414660527541/C21071-11, C21071-11-01; 5414660527572/C24244-09; 5414660527589/C24245-09; 5414660527602/C26524-06; 5414660527732/C29360-01; 5414660527763/C29010-04; 5414660527770/C29361-01; 5414660527831/C29351-02; 5414660527848/C29352-02; 5414660527855/C29353-03; 5414660527879/C29354-03; 5414660527909/C29355-02; 5414660527930/C28771-03; 5414660527961/C28770-03; 5414660528203/C27655-06; 5414660528210/C29373-01; 5414660528258/C29362-01; 5414660528357/C26770-07; 5414660528364/C27025-09; 5414660528395/C28624-06; 5414660528487/C25239-06; 5414660528500/C20744-14; 5414660528562/C29379-01; 5414660528814/C29386-01; 5414660528852/C29389-01; 5414660528876/C29375-03; 5414660528944/C29387-01; 5414660529019/C24896-10; 5414660529064/C29394-01; 5414660529095/C29305-02; 5414660529194/C29406-01; 5414660529293/C24343-05; 5414660529316/C24342-05; 5414660529729/C22186-07; 5414660529781/C22187-07; 5414660529859/C24485-11; 5414660529927/C28619-07; 5414660530008/C29415-01; 5414660530022/C29417-01; 5414660530077/C29391-01;... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0581-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide - US Nationwide distribution including in the states of PA, MN, CA, FL, LA, CO, KS, IL, AK, OH, NY, NM, DE, TX, GA, NJ, MI, SC, AR, IN, OR, VA, WI, AZ, TN, KY, AL, MA, WA, NE, MT, SD, CT, NC, MO, UT, WY, DC, NH, MD, ID, RI, ND, HI, ME, IA, MS, NV, OK, WV, VT and the countries of GB, CA, IE, CH, JP, AT, CZ, GR, HU, PL, TR, ZA, MU, ZM, SA, IL, KW, BD, UZ, LB, LV, AZ, MN, IR, MK, VN, MT, AE, ID, CY, MD, RS, QA, LK, DZ, EG, TN, BG, OM, HR, KH, IT, NL, LU, BE, JO, BH, ES, PT, FI, SE, DK, IS, RO, RU, UA, DE, FR, MQ, AU, NZ, HK, MO, SG, PH, PF, GF, GP, NC, RE, KR, IN, TH, TW, MY, BN, CN, IQ, SI, MA, CL, EC, MX, PE, PK, AR, BR, CO, UY, JM, BS, DO, TT, GT, CR, BB, AW, SK, KZ, BY, AM, SV, SR, KG, UG, PA, NI, PY, HN. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Dec 3, 2025 - **Recall initiation date**: Sep 15, 2025 - **Center classification date**: Nov 21, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0581-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Alcon Research, LLC records](https://isitonrecall.com/brand/alcon-research-llc/)