Recalls affecting Alaska

FDA has not published a risk classification for this recall yet.

Recall #:

99002

Lot/product code:

Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639.

Recalling firm:

Abiomed, Inc.

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0586-2026

Lot/product code:

Batch # E2612116, Exp Date: April 2029.

Recalling firm:

Zep Inc

FDA has not published a risk classification for this recall yet.

Recall #:

99031

Lot/product code:

GTIN 00763000341367, Lot Numbers: 0012508285, 0012517045, 0012526102, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663878, 0012663879, 0012690218, 0012699635, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713, 0012804152, 0012804579, 0012824770, 0012824771, 0012874526, 0012896853, 0012896884, 0012910323, 0012965210, 0012965211, 0012976400, 0012986693, 0013063766, 0013063767, 0013105039, 0013105040, 0013133457, 0013181623, 0013181624, 0013236643, 0013272796, 0013272798. GTIN 00763000544027, Lot Numbers: 0012508285, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663879, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713, 0012804152, 0012804579, 0012824771, 0012874526, 0012896853, 0012896884, 0012910323, 0012965211, 0012976400, 0012986693, 0013063767, 0013105039, 0013105040, 0013133457, 0013181623, 0013181624. GTIN 00763000520151, Lot Numbers: 0012575897, 0012642965, 0012728368, 0013272799. GTIN 00763000582951, Lot Numbers: 0012590535, 0012606411, 0012606413, 0012642964, 0012659418, 0012678282, 0012690219, 0012699637, 0012804151, 0012804580, 0012874527, 0012888682, 0012896885, 0012965221, 0012986699, 0013063764, 0013063765, 0013105037, 0013227504. GTIN 00763000918712, Lot Numbers: 0012635392, 0012676200, 0012690207, 0012874528, 0012874529, 0013015539, 0013105038.

Recalling firm:

Medtronic Heart Valves Division

FDA has not published a risk classification for this recall yet.

Recall #:

99002

Lot/product code:

Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.

Recalling firm:

Abiomed, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

99002

Lot/product code:

1. Impella Set Product Code: 1000413; GTIN: 00813502013566; Serial numbers: 649727, 649728, 649729, 649730, 649731, 654349, 654348, 654342, 654341, 654340, 654339, 654338, 654336, 654335, 654334, 654333, 653010, 653009, 653008, 653007, 653006, 653005, 653004, 653003, 653002, 653001, 655735, 655733, 654357, 654356, 654382, 654383, 654381, 654380, 654378, 654367, 654366, 654364, 654365, 654362, 654363, 654361, 654360, 654359, 654358, 654379, 655734, 654386, 654355, 654385, 654384, 654353, 654352, 654351, 654350, 654387, 657649, 657648, 657646, 657647, 657645, 657644, 655742, 655739, 655741, 655740, 655738, 655737, 655736, 656743, 656738, 653050, 653049, 653048, 653047, 653045, 653044, 653043, 653042, 653041. Introducer Product Code: 2000684; Batch Numbers: 2026724558, 2027818724. 2. Product Code: 1000834. GTIN: 00813502013948. Serial numbers: 653474, 653471, 653485, 653470, 653469, 653468, 653467, 653465, 653466, 653463, 653464, 653482, 653483, 653484, 653481, 653490, 653462, 653478, 653479, 653489, 653488, 653487, 653486, 653476, 653477, 656002, 656001, 656000, 655998, 655997, 655993, 655996, 655995, 655994, 656737, 656736, 656735, 656734, 656733, 656730, 656731, 656729, 656728, 656346, 656343, 656342, 656341, 656340, 656338, 659804, 659795, 656347, 650264, 659801, 659802, 659800, 659799, 659798, 656363, 656367, 656362, 656361, 656360, 656359, 656358, 659794, 659793, 659791, 659792, 659790, 659789, 659788, 659786, 659787, 659785, 661408, 661407, 661405, 661404, 661392, 661391, 661389, 661403, 661402, 661401, 661400, 662657, 662654. Introducer Product Code: 2000785; Batch Numbers: 2026787668, 2027818660. Distributed in Japan.

Recalling firm:

Abiomed, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

99143

Lot/product code:

Incorrect Catalogue Number/UDI: VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796; Lot Serial No. 30970948, 30970949, 30970950, 30970951, 30970952, 30970953, 30970954, 30970955, 30970956, 30970957, 30970958, 30970959, 30970960.

Recalling firm:

W L Gore & Associates, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

99035

Lot/product code:

GTIN: 07630002800839/ Lot # range: 00001 -19732

Recalling firm:

Hamilton Medical AG

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:

H-0942-2026

Lot/product code:

1. Lot: 2507199 Exp. 09/2027 Lot: 2512-304 Exp. 02/2028 Lot: 2793 Exp. 02/2028 Lot: 2748 Exp. 07/2027 ASIN: B0DBRDPBDT, SKU: AB8047, UPC: 095234280472, FNSKU: X004C9XHAL 2. Lot: 2507199 Exp. 09/2027 Lot: 2748 Exp. 07/2027 UPC: 095234698734; SKU: AB9873

Recalling firm:

Total Nutrition Inc

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0598-2026

Lot/product code:

Lot #: AD93852, Exp Date: 06/2027.

Recalling firm:

SUN PHARMACEUTICAL INDUSTRIES INC

FDA has not published a risk classification for this recall yet.

Recall #:

99189

Lot/product code:

UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.

Recalling firm:

Windstone Medical Packaging, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

99162

Lot/product code:

1) ART1145, UDI-DI: 10653160349259(each), 00653160349252(case), Lot Number: 2025120590; 2) ART1145, UDI-DI: 10653160349259(each), 00653160349252(case), Lot Number: 2025101490; 3) ART155A, UDI-DI: 10653160316459(each), 00653160316452(case), Lot Number: 2025100890; 4) ART1010B, UDI-DI: 10653160353577(each), 00653160353570(case), Lot Number: 2025091590

Recalling firm:

Medline Industries, LP

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0606-2026

Lot/product code:

BNZ-001921, Exp 04/15/2029

Recalling firm:

Keystone Industries

FDA has not published a risk classification for this recall yet.

Recall #:

98898

Lot/product code:

Model Number: Papablic18B; Amazon FNSKU: X004LOZKE3; Lot Numbers: PS2509A01, PS2511A01, PS2512A01; Date Codes: 2509, 2511, 2512. The recalled product is limited to Papablic18B replacement brush head packs bearing the above lot numbers/date codes. Products with other lot numbers/date codes are not included in this recall.

Recalling firm:

Papablic Inc

FDA has not published a risk classification for this recall yet.

Recall #:

99128

Lot/product code:

Part No. 00055360010 UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F; Part No. 00055360011 UDI-DI 08426950807605 Lots 260505F and 260505J; Part No. 00055407504 UDI-DI 08426950807537 Lot 260505R; Part No. 00055415010 UDI-DI 08426950807698 Lots 260505H and 260505K; Part No. 00055430010 UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F; Part No. 00055430011 UDI-DI 08426950807766 Lot 260505K; Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K; Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J; Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF;

Recalling firm:

Instrumentation Laboratory

FDA has not published a risk classification for this recall yet.

Recall #:

99162

Lot/product code:

1) PAIN1699A, UDI-DI: 10195327411107(each), 40195327411108(case), Lot Number: 25JLA719

Recalling firm:

Medline Industries, LP

FDA has not published a risk classification for this recall yet.

Recall #:

98980

Lot/product code:

Software Version: MOSAIQ 3.2/UDI: 07340201500071

Recalling firm:

Elekta, Inc.

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0605-2026

Lot/product code:

BNZ-001921, EXP 04/15/2029

Recalling firm:

Keystone Industries

FDA has not published a risk classification for this recall yet.

Recall #:

99096

Lot/product code:

OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 Lot Number: REKY3402 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 Lot Number: REKY3397 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 Lot Number: REKY3386

Recalling firm:

Bard Access Systems, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

99067

Lot/product code:

UPN: M00558480; GTIN: 8714729339410; Lot No. 38033567, 38056239, 38056940, 38056941, 38215260, 38266854, 38266855, 38293330, 38391881, 38413876, 38413877, 38413878, 38413879, 38414080, 38422547, 38446204, 38466097, 38468862, 38468863, 38529518, 38529519, 38585004, 38622477, 38622478, 38640994, 38670501, 38670502, 38670504, 38686282, 38686283, 38693725, 38726666, 38726667, 38748254, 38767487, 38789996, 38800181, 38879160, 38879163, 38879164, 38911928, 38911929, 38911930, 38944841; Exp. October 24, 2028 February 24, 2029.

Recalling firm:

Boston Scientific Corporation

FDA has not published a risk classification for this recall yet.

Recall #:

99162

Lot/product code:

1) CIT6780, UDI-DI: 10653160324232(each), 00653160324235(case), Lot Number: 2025102790; 2) CIT3225A, UDI-DI: 00653160165142(each), 10653160165149(case), Lot Number: 2025102190; 3) CIT6325, UDI-DI: 10653160294160(each), 00653160294163(case), Lot Number: 2025102390

Recalling firm:

Medline Industries, LP

FDA has not published a risk classification for this recall yet.

Recall #:

99067

Lot/product code:

UPN: M00558500; GTIN: 8714729339434; Lot No. 38033572, 38063250, 38063251, 38063252, 38211783, 38211784, 38215261, 38215262, 38215263, 38222236, 38222237, 38222238, 38222239, 38241879, 38242360, 38242361, 38334062, 38334063, 38347338, 38468864, 38472364, 38472365, 38479755, 38596733, 38596734, 38596735, 38596736, 38596883, 38596884, 38692526, 38707831, 38709738, 38709739, 38748244, 38808896, 38874312, 38874313, 38874314, 38886248, 38886249; Exp. October 24, 2028 February 17, 2029.

Recalling firm:

Boston Scientific Corporation

FDA has not published a risk classification for this recall yet.

Recall #:

99067

Lot/product code:

UPN: M00558710; GTIN: 8714729797593; Lot No. 38031485, 38031486, 38031487, 38031488, 38031489, 38031490, 38031642, 38031643, 38031644, 38031645, 38043600, 38043601, 38043602, 38043603, 38043604, 38055580, 38055581, 38055582, 38099704, 38099705, 38099706, 38099707, 38099709, 38099710, 38099711, 38099712, 38099713, 38099714, 38099715, 38110376, 38110377, 38110378, 38110379, 38131547, 38131548, 38150880, 38150881, 38150882, 38150883, 38162872, 38162873, 38162874, 38162875, 38169202, 38169203, 3818825438188255, 38193520, 38241877, 38241878, 38258885, 38258886, 38258887, 38258888, 38258889, 38278151, 38285220, 38285221, 38306689, 38306692, 38338285, 38338288, 38338290, 38338292, 38338294, 38338296, 38338297, 38338299, 38338301, 38347330, 38462126, 38462127, 38462128, 38462129, 38479753, 38479754, 38553523, 38553524, 38553525, 38608098, 38608099, 38612875, 38612876, 38612877, 38612878, 38622479, 38622600, 38622601, 38622602, 38622603, 38642700, 38642701, 38642702, 38642722, 38650472, 38665039, 38665260, 38665261, 38665262, 38665263, 38678316, 38678317, 38678318, 38678319, 38678760, 38702327, 38702328, 38702329, 38702330, 38702331, 38702332, 38709525, 38709526, 38709527, 38709528, 38734736, 38742717, 38742718, 38745588, 38745589, 38745590, 38748246, 38748247, 38748248, 38808893, 38808894, 38808897, 38808899, 38809140, 38823455, 38823456, 38823457, 38874308, 38874309, 38874310, 38874311, 38877005, 38877006, 38886252, 38886253, 38886254, 38886255, 38946205, 38946207, 38946209, 38959786, 38964092, 38964093; Exp. November 23, 2028 March 29, 2029.

Recalling firm:

Boston Scientific Corporation

FDA has not published a risk classification for this recall yet.

Recall #:

99128

Lot/product code:

Part No.00077407508 UDI-DI 00195226000764 Lot 260504E; Part No. 00077407510 UDI-DI 00195226000665 Lot 260505B; Part No. 00077415004 UDI-DI 00195226000856 Lot 260505A; Part No. 00077415008 UDI-DI 00195226000757 Lot No.260505A; Part No. 00077415010 UDI-DI 00195226000658 Lot 260505C; Part No. 00077430010 UDI-DI 00195226000641 Lot 260505B

Recalling firm:

Instrumentation Laboratory

FDA has not published a risk classification for this recall yet.

Recall #:

99162

Lot/product code:

1) DYNDH1068, UDI-DI: 10889942172122(each), 40889942172123(case), Lot Number: 2025101090; 2) PHS234706I, UDI-DI: 10198459330278(each), 40198459330279(case), Lot Number: 25JLB029

Recalling firm:

Medline Industries, LP

FDA has not published a risk classification for this recall yet.

Recall #:

99162

Lot/product code:

1) ECVC8520, UDI-DI: 10653160375104(each), 00653160375107(case), Lot Number: 2026031790; 2) CVI4880B, UDI-DI: 10653160377191(each), 00653160377194(case), Lot Number: 2026021190; 3) ART356, UDI-DI: 10653160375371(each), 00653160375374(case), Lot Number: 2026011990; 4) STCVC03, UDI-DI: 10653160365235(each), 00653160365238(case), Lot Number: 2026011990; 5) ARTNC217, UDI-DI: 10653160383352(each), 00653160383355(case), Lot Number: 2025121190; 6) ECVC1720, UDI-DI: 10653160365761(each), 00653160365764(case), Lot Number: 2025121990; 7) CVI4815, UDI-DI: 10653160386049(each), 00653160386042(case), Lot Number: 2025121890; 8) STCVC04, UDI-DI: 10653160339342(each), 00653160339345(case), Lot Number: 2025121890; 9) ECVC8520, UDI-DI: 10653160375104(each), 00653160375107(case), Lot Number: 2025122290; 10) ART350, UDI-DI: 10653160362050(each), 00653160362053(case), Lot Number: 2025120890; 11) ECVC6355, UDI-DI: 10653160336396(each), 00653160336399(case), Lot Number: 2025120890; 12) UVT980, UDI-DI: 10653160376705(each), 00653160376708(case), Lot Number: 2025120990; 13) ECVC5480, UDI-DI: 10653160380368(each), 00653160380361(case), Lot Number: 2025122290; 14) P972300A, UDI-DI: 10653160377467(each), 00653160377460(case), Lot Number: 2025120490; 15) ECVC825A, UDI-DI: 10653160387596(each), 00653160387599(case), Lot Number: 2025120490; 16) ECVC8640, UDI-DI: 10653160390848(each), 00653160390841(case), Lot Number: 2025122390; 17) SPEC0291B, UDI-DI: 10653160382003(each), 00653160382006(case), Lot Number: 2026010790; 18) ECVC7605, UDI-DI: 10653160364498(each), 00653160364491(case), Lot Number: 2026010890; 19) ECVC7330, UDI-DI: 10653160364566(each), 00653160364569(case), Lot Number: 2026010790; 20) ECVC7600, UDI-DI: 10653160364443(each), 00653160364446(case), Lot Number: 2026010790; 21) ECVC8110, UDI-DI: 10653160377207(each), 00653160377200(case), Lot Number: 2025120890; 22) ART660A, UDI-DI: 10653160366096(each), 00653160366099(case), Lot Number: 2025120990; 23) ECVC5370B, UDI-DI: 10653160385905(each), 00653160385908(case), Lot Number: 2025120990; 24) A3720KIC, UDI-DI: 10653160376354(each), 00653160376357(case), Lot Number: 2025121090; 25) DYNJ70152MB, UDI-DI: 10653160366157(each), 00653160366150(case), Lot Number: 2025121290; 26) ECVC8180, UDI-DI: 10653160378235(each), 00653160378238(case), Lot Number: 2025121290; 27) ECVC8595, UDI-DI: 10653160378822(each), 00653160378825(case), Lot Number: 2025091890; 28) DYNDA1954A, UDI-DI: 10653160387060(each), 00653160387063(case), Lot Number: 2025102390; 29) ECVC7040A, UDI-DI: 10653160369165(each), 00653160369168(case), Lot Number: 2025102390; 30) SUT10830A, UDI-DI: 10653160386902(each), 00653160386905(case), Lot Number: 2025102390; 31) SUT10520, UDI-DI: 10653160364672(each), 00653160364675(case), Lot Number: 2025102790; 32) CMPV7203LBB, UDI-DI: 10653160360025(each), 00653160360028(case), Lot Number: 2025120190; 33) ECVC8380B, UDI-DI: 10653160382409(each), 00653160382402(case), Lot Number: 2025112590; 34) MNS7065A, UDI-DI: 10193489196566(each), 20193489196563(case), Lot Number: 2025120190; 35) I500BF85, UDI-DI: 10653160378785(each), 00653160378788(case), Lot Number: 2025120290; 36) ART690, UDI-DI: 10653160318019(each), 00653160318012(case), Lot Number: 2025120390; 37) ECVC5490, UDI-DI: 10653160363309(each), 00653160363302(case), Lot Number: 2025120390; 38) ECVC8633, UDI-DI: 10653160390428(each), 00653160390421(case), Lot Number: 2025120490; 39) ECVC6920A, UDI-DI: 10653160389392(each), 00653160389395(case), Lot Number: 2025120890; 40) DYNDH1135B, UDI-DI: 10653160387459(each), 00653160387452(case), Lot Number: 2025120390; 41) CHT1825, UDI-DI: 10653160385660(each), 00653160385663(case), Lot Number: 2025120490; 42) ECVC7485, UDI-DI: 10653160372738(each), 00653160372731(case), Lot Number: 2025120490; 43) CVI190, UDI-DI: 00653160001372(each), 50653160001377(case), Lot Number: 2025120590; 44) SPEC0051, UDI-DI: 10653160387503(each), 00653160387506(case), Lot Number: 2025120290; 45) CMPM7203LBB, UDI-DI: 10653160363798(each), 00653160363791(case), Lot Number: 2025120290; 46) ECVC1490A, UDI-DI: 10653160367147(each), 00653160367140(case), Lot Number: 2025120590; 47) ECVC3505, UDI-DI: 10653160364467(each), 00653160364460(case), Lot Number: 2025120590; 48) DYNDH1406, UDI-DI: 10653160375739(each), 00653160375732(case), Lot Number: 2025121090; 49) ECVC8632, UDI-DI: 10653160390442(each), 00653160390445(case), Lot Number: 2025121290; 50) ID1135A, UDI-DI: 00653160204056(each), 10653160204053(case), Lot Number: 2025120490; 51) ECVC8637, UDI-DI: 10653160389538(each), 00653160389531(case), Lot Number: 2025112690; 52) ECVC5080, UDI-DI: 10653160363194(each), 00653160363197(case), Lot Number: 2025120190; 53) ECVC1970B, UDI-DI: 10653160362975(each), 00653160362978(case), Lot Number: 2025120490; 54) ECVC7675, UDI-DI: 10653160348122(each), 00653160348125(case), Lot Number: 2025112090; 55) CVI5331, UDI-DI: 10653160383017(each), 00653160383010(case), Lot Number: 2025120390; 56) CMPV7203LBPA, UDI-DI: 10653160367529(each), 006531… (truncated, 31025 characters total — see the official FDA record for the full value)

Recalling firm:

Medline Industries, LP