Drug & Device Safety Atlas
Class II FDA device recall · Z-0581-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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; CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06; CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05; CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06; CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04; CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05; CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1

Why it was recalled

XXX

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information 
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; 5414660530084/C29396-01; 5414660530091/C29302-03; 5414660530152/C28852-04; 5414660530350/C28856-05; 5414660530411/C27086-05; 5414660530428/C27091-06; 5414660530473/C28855-05; 5414660530541/C27007-04; 5414660530589/C24127-10, C24127-10-01; 5414660530596/C24483-08; 5414660530633/C16833-13; 5414660530657/C21630-16; 5414660530671/C22954-11, C22954-11-01; 5414660530688/C24090-08; 5414660530695/C24794-09; 5414660530701/C25472-14; 5414660530725/C22951-11, C22951-11-01; 5414660530732/C24087-11; 5414660530763/C25683-11; 5414660530770/C25684-11; 5414660530787/C26763-07; 5414660530794/C28712-03; 5414660530817/C20014-13; 5414660530824/C23790-14; 5414660530831/C28482-08, C28482-07-01; 5414660530992/C24089-13; 5414660531104/C28374-04; 5414660531128/C29223-03; 5414660531135/C29239-02; 5414660531142/C29241-02; 5414660531166/C29224-03; 5414660531173/C29226-03; 5414660531197/C28375-06; 5414660531210/C23818-09; 5414660531227/C24088-13; 5414660531272/C29227-03; 5414660531388/C26172-04; 5414660531630/C20486-17; 5414660531722/C29029-02; 5414660531777/C26156-06; 5414660531784/C27088-04; 5414660532071/C24450-07; 5414660532132/C22029-06; 5414660532248/C20349-07; 5414660532361/C29032-02; 5414660532385/C19676-16; 5414660532392/C24604-11; 5414660532415/C28462-04; 5414660532422/C28470-04; 5414660532446/C29033-02; 5414660532484/C21066-09; 5414660532514/C27090-04; 5414660532552/C29031-02; 5414660532606/C24780-09; 5414660532637/C27084-05; 5414660532743/C28854-04; 5414660532750/C29030-02; 5414660532941/Q29257-01; 5414660532958/Q29258-01; 5414660532972/Q29260-01; 5414660532989/Q29261-01; 5414660533009/C26625-07; 5414660533030/C28074-04; 5414660533344/C16966-15, C16966-15-01, C16966-16, C16966-16-01; 5414660533511/C22248-07; 5414660533528/C16967-14, C16967-14-01; 5414660533603/C24934-13; 5414660533610/C24936-09; 5414660533658/C24935-16; 5414660533689/C22541-11; 5414660533696/C22543-10; 5414660534082/C25590-08; 5414660534143/C20492-16; 5414660534167/C23619-10; 5414660534174/C23620-09; 5414660534181/C24725-13; 5414660534242/C26097-05; 5414660534297/C20490-24; 5414660534303/C24387-11; 5414660534655/C25662-09; 5414660534686/C29277-02; 5414660534792/C28991-05; 5414660534860/C23137-12; 5414660534877/C25132-09; 5414660534907/C29426-01; 5414660534914/C22540-11; 5414660534921/C25227-09; 5414660534938/C26815-08; 5414660534945/C29037-07; 5414660535065/C24966-10; 5414660535089/C24671-05; 5414660535102/C20678-10; 5414660535119/C22203-06; 5414660535126/C28294-02; 5414660535133/C24133-16; 5414660535140/C25087-06; 5414660535157/C26175-06; 5414660535171/C28079-04; 5414660535188/C25226-10; 5414660535218/C28952-06; 5414660535225/C26176-07; 5414660535249/C28954-07; 5414660535423/C19827-16; 5414660535454/C28953-06; 5414660535607/C19619-11; 5414660535713/C26489-04; 5414660535737/C27911-06; 5414660535775/C22061-13; 5414660535874/C26739-10; 5414660535904/C27610-05; 5414660535911/C28517-06; 5414660535928/C29428-01; 5414660535942/C19829-18; 5414660535959/C22201-07; 5414660535966/C27818-03; 5414660535997/C19081-11, C19081-11-01; 5414660536024/C23736-13; 5414660536031/C25184-08; 5414660536048/C27496-05; 5414660536055/C27396-05; 5414660536079/C25486-08; 5414660536086/C27397-05; 5414660536130/C28304-06; 5414660536154/C25088-08; 5414660536208/C26490-05; 5414660536222/C27395-05; 5414660536352/C19976-16; 5414660536543/C19899-16; 5414660536567/C28823-08; 5414660536574/C29006-06; 5414660536635/C24900-05, C24900-05-01; 5414660536666/C29047-04; 5414660536765/C25910-06; 5414660536796/C19898-19; 5414660536802/C22323-08; 5414660536826/C20006-18; 5414660536840/C25607-06; 5414660536857/C27398-05; 5414660536864/C27961-08; 5414660537410/C21731-04; 5414660537427/C21304-12, C21304-12-01; 5414660537434/C29138-04; 5414660537458/C25064-06, C25064-06-01; 5414660537489/C25766-06; 5414660537564/C28999-02; 5414660537595/C29139-03; 5414660537816/C24933-13; 5414660537830/C25435-10; 5414660537847/C29438-01; 5414660537885/C25323-05; 5414660537892/C29433-01; 5414660538240/C26224-07; 5414660538271/C24895-09; 5414660538288/C24896-11; 5414660538295/C25185-08; 5414660538363/C28764-03; 5414660538516/C29323-02; 5414660538554/C21113-13; 5414660538561/C21813-14; 5414660538592/C29322-02; 5414660538639/C23806-08; 5414660538707/C22544-12; 5414660538738/C19778-27; 5414660538820/C23050-18; 5414660538882/C29420-02; 5414660538936/C29246-03; 5414660538974/C29217-03; 5414660538998/C29089-06; 5414660539063/C29335-02; 5414660539070/C29439-01; 5414660539100/C29434-01; 5414660539209/C28891-06; 5414660539230/C24374-07; 5414660539308/C29240-03; 5414660539339/C25858-11; 5414660539360/C20682-11; 5414660539377/C21121-12; 5414660539544/C20681-12; 5414660539582/C28620-05; 5414660539643/C28671-05; 5414660539681/C25531-12; 5414660539711/C29445-01; 5414660539803/C20843-08; 5414660539810/C23723-15; 5414660539858/C27723-04; 5414660539865/C27724-04; 5414660539902/C26019-10; 5414660539919/C26474-05; 5414660539926/C28031-05; 5414660539933/C29450-01; 5414660540007/C27713-03; 5414660540076/C22498-13; 5414660540120/C25279-10; 5414660540175/C27810-11; 5414660540182/C22590-10; 5414660540199/C27794-03; 5414660540229/C27811-13; 5414660540304/C24603-11; 5414660540335/C24604-12; 5414660540397/C28357-03; 5414660540427/C26855-10; 5414660540465/C24602-09; 5414660540496/C22367-20; 5414660540540/C24812-09; 5414660540601/C21410-07; 5414660540625/C29464-01; 5414660540656/C26851-04; 5414660540687/C29469-01; 5414660540748/C29468-01; 5414660540755/C21873-12; 5414660540762/C25475-14; 5414660540786/C26521-05; 5414660540793/C26854-10; 5414660540809/C27896-01; 5414660540823/C21876-12; 5414660540830/C24962-08; 5414660541004/C25661-04; 5414660541028/C21111-14; 5414660541141/C25663-10; 5414660541158/C22544-13; 5414660541172/C15050-21; 5414660541240/C25662-10; 5414660541257/C22540-12; 5414660541295/C28602-07; 5414660541516/C20017-09; 5414660541523/C20018-10; 5414660541608/C20349-08; 5414660541622/C24483-09; 5414660541639/C24570-06; 5414660541707/C29483-01; 5414660541721/C29480-01; 5414660541738/C29481-01; 5414660541813/C28326-02; 5414660541820/C28327-02; 5414660541844/C29489-01; 5414660541851/C29490-01; 5414660541868/C28320-04; 5414660541882/C24387-12; 5414660541912/C20490-25; 5414660541950/C22375-14; 5414660542094/C29492-01; 5414660542124/C29493-01; 5414660542209/C20006-19; 5414660542223/C26474-06; 5414660542292/C25994-10; 5414660542308/C27787-06; 5414660542322/C24442-09; 5414660542353/C28265-06; 5414660542377/C22432-10; 5414660542483/C27789-07; 5414660542506/C21650-10; 5414660542698/C28253-04; 5414660542704/C29497-01; 5414660542711/C29498-01; 5414660542735/C19988-23; 5414660542759/C19976-17; 5414660542773/C28256-06; 5414660542841/C23667-17; 5414660542858/C25203-11; 5414660542865/C25206-11; 5414660542940/C28708-04; 5414660542971/C29500-01; 5414660542988/C25366-07; 5414660543008/C17593-15; 5414660543022/C25367-07; 5414660543053/C29498-02; 5414660543084/C26282-05; 5414660543145/C27995-03; 5414660543213/C28370-09; 5414660543220/C24075-09; 5414660543237/C28993-04; 5414660543251/C24255-10; 5414660543299/C22871-11; 5414660543305/C29497-02; 5414660543312/C11112-13; 5414660543336/C21555-06; 5414660543435/C29433-02; 5414660543497/C26172-05; 5414660543602/C25132-10; 5414660543619/C27993-03; 5414660543756/C28250-04; 5414660543787/C28251-04; 5414660543817/C27441-04; 5414660543824/C28819-04; 5414660543855/C29520-01; 5414660543879/C25910-07; 5414660543916/C24002-06; 5414660543985/C22172-16; 5414660544005/C26907-05; 5414660544012/C27444-03; 5414660544036/C27440-03; 5414660544043/C27443-03; 5414660544067/C25571-04; 5414660544074/C25574-04; 5414660544241/C24374-08; 5414660544272/C28403-05; 5414660544333/C23378-08; 5414660544371/C29523-01; 5414660544395/C29524-01; 5414660544401/C23620-10; 5414660544463/C25322-07; 5414660544470/C25321-09; 5414660544487/C26623-09; 5414660544500/C26097-06; 5414660544524/C23619-11; 5414660544531/C26621-09; 5414660544593/C29526-01; 5414660544654/C25766-07; 5414660544722/C28024-02; 5414660544777/C29528-01; 5414660544876/C29530-01; 5414660544883/C29529-01; 5414660544906/C26341-06; 5414660544944/C27457-04; 5414660545002/C19676-17; 5414660545156/C29533-01; 5414660545279/C23736-14; 5414660545491/C29550-01; 5414660545583/C29554-01; 5414660545613/C29545-01; 5414660545620/C29548-01; 5414660545644/C29549-01; 5414660545675/C29552-01; 5414660545682/C29541-01; 5414660545712/C29547-01; 5414660545736/C26783-10; 5414660545743/C26784-07; 5414660545798/C21650-11; 5414660545828/C29551-01; 5414660545835/C22383-06; 5414660545910/C28428-03; 5414660545996/C29557-02; 5414660546016/C29227-04; 5414660546023/C25184-09; 5414660546054/C29555-01; 5414660546078/C26521-06; 5414660546085/C29562-01; 5414660546092/C24814-06; 5414660546115/C27396-06; 5414660546122/C25200-11; 5414660546153/C27397-06; 5414660546177/C29565-01; 5414660546214/C23667-18; 5414660546221/C28462-05; 5414660546269/C28470-05; 5414660546344/C29572-01; 5414660546368/C29570-01; 5414660546375/C29569-01; 5414660546412/C24794-10; 5414660546436/C16833-14; 5414660546498/C27455-04; 5414660546535/C20578-09, C20578-09-01; 5414660546542/C23502-08; 5414660546566/C23233-07; 5414660546580/C29581-01; 5414660546641/C21958-09, C21958-09-01; 5414660546658/C23503-08; 5414660546665/C29578-01; 5414660546696/C17271-08; 5414660546740/C24333-06; 5414660546771/C29584-01; 5414660546863/C22540-13; 5414660546870/C22544-14; 5414660546887/C25662-11; 5414660546894/C25663-11; 5414660546962/C22543-11; 5414660546979/C29590-01; 5414660546993/C29589-01; 5414660547037/C29588-01; 5414660547051/C22541-12; 5414660547211/C22879-10; 5414660547273/C29596-01; 5414660547310/C22172-16-01, C22184-16; 5414660547327/C22185-14; 5414660547341/C27911-05; 5414660547365/C24450-08; 5414660547495/C29557-03; 5414660547532/C26623-10; 5414660547556/C28294-03; 5414660547587/C20492-17; 5414660547600/C26621-10; 5414660547655/C25766-08; 5414660547662/C20490-26; 5414660547686/C22203-07; 5414660547754/C20486-18; 5414660547785/C22201-08; 5414660547822/C29606-01; 5414660547945/C28376-07; 5414660548058/C16562-15; 5414660548072/C27810-10; 5414660548089/C26156-07; 5414660548096/C27811-12; 5414660548119/C29610-01; 5414660548140/C24780-10; 5414660548157/C27813-08; 5414660548225/C29613-01; 5414660548362/C29614-01; 5414660548447/C26740-09; 5414660548478/C25225-10; 5414660548492/C26739-11; 5414660548522/C25226-11; 5414660548546/C29612-01; 5414660548614/C29600-02; 5414660548638/C22187-10; 5414660548683/C16966-17; 5414660548690/C16967-16, C16967-16-01; 5414660548706/C22186-09; 5414660548713/C25386-06; 5414660548720/C29598-02; 5414660548744/C29616-01; 5414660548775/C24904-07; 5414660548805/C24671-06; 5414660548881/C26040-05; 5414660548928/C26041-07; 5414660549024/C25279-11; 5414660549079/C29305-03; 5414660549178/C28894-03; 5414660549192/C29565-02; 5414660549314/C29634-01; 5414660549345/C20937-06; 5414660549352/C22778-05; 5414660549383/C27703-03; 5414660549451/C27709-07; 5414660549499/C29434-02; 5414660549512/C29632-01; 5414660549529/C29638-01; 5414660549574/C25138-12; 5414660549642/C25139-11; 5414660549666/C28403-04; 5414660549673/C29641-01; 5414660549680/C29640-01; 5414660549727/C29633-01; 5414660549758/C29642-01; 5414660549871/C29649-01; 5414660549970/C29647-01; 5414660550051/C22777-06; 5414660550266/C29110-02; 5414660550273/C29111-03; 5414660550303/C28707-04; 5414660550334/C29656-01; 5414660550389/C29654-01; 5414660550464/C23842-12; 5414660550471/C26231-08; 5414660550488/C25047-06; 5414660550495/C26189-08; 5414660550624/C25296-06; 5414660550747/C26224-08; 5414660550976C26341-07; 5414660550983/C27457-05; 5414660551003/C29665-01; 5414660551041/C26390-04; H5301ALCON1CPAK10/19853-02, 12568-09, 16669-09, 13501-08, 13591-13, 15491-05, 15491-06, 16463-06, 13502-10, 17261-06, 13592-15, 15223-13, 16667-10, 19230-04, 19230-05, 19230-06, 10924-15, 19218-03, 15493-05, 15493-06, 16462-08, 16668-10, 15492-02, 15492-03, 12852-16, 20106-01, 20114-01,  20114-02, 20152-01, 15295-12, 15421-13, 15421-14, 18319-06, 18728-11, 15464-05, 18858-02, 15553-05, 15465-05, 17168-02, 14956-08, 14956-07, 20229-01, 15853-05, 15167-08, 16559-06, 15108-09, 16180-05, 16180-06, 15324-07, 14541-16, 15552-05, 16223-08, 17468-06, 14669-10, 14669-11, 20230-01, 19718-01, 19718-02, 17704-05, 16914-03, 16496-07, 19697-01, 19697-02, 19697-03, 17804-05,  17804-06, 15722-08, 16630-07, 16630-08, 14540-08, 14603-15, 4517-60, 4517-59, 14532-06, 14532-07, 16467-03,  14671-09, 17467-04, 14501-09, 19717-01, 19717-02, 17703-04, 19249-02, 2099-62, 15525-04, 14672-11, 16179-05, 15006-06, 14597-07, 20083-01, 19694-01, 19694-03, 19694-04, 15006-07, 18753-04, 14873-06, 14873-07, 18058-04, 14512-09, 14512-10, 15723-08, 15318-05, 15318-06, 15318-07, 19098-02, 17585-03, 17585-04, 17585-05, 19531-01, 19531-02, 15852-05, 18150-04, 18150-05, 18723-11, 18723-12, 18723-10, 15455-08, 15455-09,  15455-10, 15456-04, 15456-05, 15456-06, 15294-14, 14955-09, 14955-08, 17141-06, 17141-07, 20147-01, Q39446B, 19037-03, AS19037-03, Q39448B, 19037-05, AS19037-05, 17000-03, AS17000-03, 15576-04, AS15576-04, 18202-01, AS18202-01, 16677-03, AS16677-03, 16481-04, AS16481-04, 17263-02, AS17263-02, 15642-08, AS15642-08, 16334-03, AS16334-03, 14283-12, AS14283-12, 18131-03, AS18131-03, 19009-01, AS19009-01, 8224-65, AS8224-65, 18703-01, AS18703-01, 17262-02, AS17262-02, 17770-04, AS17770-04, 16335-03, AS16335-03, 18130-03, AS18130-03, 19010-01, AS19010-01, 15877-07, AS15877-07, 18702-01, AS18702-01, Q39315A, 15876-07, AS15876-07, 20235-02, AS20235-02, 20236-02, AS20236-02, 19657-01, AS19657-01, 19178-02, AS19178-02, 19178-04, AS19178-04, 19656-01, AS19656-01, 19200-01, 19200-02, AS19200-01, AS19200-02, 19150-02, 19150-03, AS19150-02, AS19150-03, 17604-08, AS17604-08, 20234-01, AS20234-01, 19211-01, 19211-02, 19211-03, AS19211-01, AS19211-02, AS19211-03, 19212-02, 19212-03, AS19212-02, AS19212-03, 18422-02, 18421-03, 11220-25, 11220-27, 14129-10, 18186-10, 18186-14; H5301ALCON1CPAK11/AS12852-16; H5301ALCON1CPAK12/18269-02; H5301ALCON1CPAK13/AS18269-02; H5301ALCON1CPAK14/12641-13; H5301ALCON1CPAK15/12641-14; H5301ALCON1CPAK16/AS12641-13; H5301ALCON1CPAK17/AS12641-14; H5301ALCON1CPAK18/18271-02; H5301ALCON1CPAK19/AS18271-02; H5301ALCON1CPAK20/17607-05; H5301ALCON1CPAK21/AS17607-05; H5301ALCON1CPAK22/20122-01; H5301ALCON1CPAK23/AS20122-01; H5301ALCON1CPAK24/17609-04; H5301ALCON1CPAK25/17609-05; H5301ALCON1CPAK26/17609-06; H5301ALCON1CPAK27/AS17609-04; H5301ALCON1CPAK28/AS17609-05; H5301ALCON1CPAK29/AS17609-06; H5301ALCON1CPAK30/18684-05; H5301ALCON1CPAK31/AS18684-05; H5301ALCON1CPAK32/18454-07; H5301ALCON1CPAK33/AS18454-07; H5301ALCON1CPAK34/18453-05; H5301ALCON1CPAK35/18453-06; H5301ALCON1CPAK36/AS18453-05; H5301ALCON1CPAK37/17368-04; H5301ALCON1CPAK38/AS17368-04; H5301ALCON1CPAK39/17369-04; H5301ALCON1CPAK40/AS17369-04; H5301ALCON1CPAK41/19747-01; H5301ALCON1CPAK42/AS19747-01; H5301ALCON1CPAK43/16873-11; H5301ALCON1CPAK44/AS16873-11; H5301ALCON1CPAK45/18833-04; H5301ALCON1CPAK46/AS18833-04; H5301ALCON1CPAK47/16873-09; H5301ALCON1CPAK48/AS16873-09; H5301ALCON1CPAK49/18826-03; H5301ALCON1CPAK50/AS18826-03; H5301ALCON1CPAK51/16871-10; H5301ALCON1CPAK52/16871-11; H5301ALCON1CPAK53/AS16871-10; H5301ALCON1CPAK54/AS16871-11; Customer evaluation sample - UDI N/A/QNS29389-01, QNS29388-01, QNS29239-01, QNS29385-01, QNS29407-01, QNS29406-01, QNS29365-01, QNS29364-01, QNS29374-01, QNS29373-01, QNS29337-01, QNS29338-01, QNS29339-01, QNS29333-01, QNS29353-01, QNS29352-01, QNS29348-01

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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.

Recall record

Recalling firm
Alcon Research LLC
Product type
Devices
Recall number
Z-0581-2026
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Fort Worth, TX
Recall initiated
2025-09-15

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0581-2026 · Source: openFDA enforcement.