CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
Constellation Ultravit 10K and Constellation Hypervit 20K recalled
Alcon Research is recalling Constellation Ultravit 10K and Constellation Hypervit 20K, Description, distributed nationwide in the US. The recall was initiated on 15 Sep 2025 and the FDA has classified it as Class II.
Check your package
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-0581-2026
- FDA event ID
- 97728
- Recalling firm
- Alcon Research, Fort Worth, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Sep 2025
- FDA classified
- 21 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Sep 2025 | Recall initiated by company | |
| 21 Nov 2025 | Classified by FDA | +67 days |
| 3 Dec 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
XXX
Product as listed by the FDA
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
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Stores named: CVS
Questions about this recall
Why was it recalled?
XXX
Which lots are affected?
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
Where was it sold?
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.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |