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Medline EBSI Kit
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MEDICAL DEVICE RECALLMODERATE

Medline EBSI Kit

Medline recalls EBSI Kit (EBSI1534) due to cracked butyrate tubing and recalled MASTISOL adhesive.

What to do

Stop using the affected kit and contact Medline for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-2438-2026
Agency
FDA
Firm
Medline Industries, LP
Recall ID
98951
Status
ONGOING

Recall at a glance

Quantity recalled
49,654 kits total

Why it was recalled

Medline is recalling its EBSI Kit (EBSI1534) because the kit contains a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive, and the butyrate tubing may crack during actuation, rendering the product unusable for application.

Is mine affected?

This recall covers 42 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DI
Medline convenience kits26AMB067Z-2434-202610198459632297
Medline convenience kit25LMI820Z-2430-202610198459028274
Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C ACL DYNJ911996 ACL ACCESSORY PACK DYNJ86584B ACL- LF DYNJ905281B ACL PACK DYNJ67271A ALIF DYNJ904848L ANTERIOR CERVICAL DYNJ901355J ARTHROSCOPY DYNJ908193B ARTHROSCOPY PACK-LF DYNJ42963M DYNJ52268B ARTHROSCOPY SHOULDER DYNJ908684A BACK CDS-LF CDS983364G BACK PACK DYNJT4339 CDH SPINE PACK DYNJ908828D CERVICAL CDS DYNJ903477J CMC ORTHO BAC–Z-2436-202610195327305024, 10198459084300, 10198459453359, 10198459357107, 10198459596230, 10198459410604, 10195327063191, 10195327626822, 10198459217500, 10198459224775, 10198459521720, 10198459611834, 10195327432423, 10198459500510, 10195327432508, 10198459448720, 10198459512919, 10195327565206, 10195327006532, 10198459559372
Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN LAPAROSCOPY CDS CDS982371I GYN LAPAROSCOPY CDS #34-RF CDS920099S GYN LAPAROSCOPY PACK DYNJT3887 DYNJT6876 GYN ROBOTIC CDS CDS984228K GYN ROBOTICS DYNJ911843 KIT LABOR DELIVERY TUBAL LIGAT DYKMBNDL165C ROBOTIC LAP CHOLE CDS CDS985442J ROBOTIC PACK DYNJ84725B DYNJ910594B ROBOTIC SURGERY PACK–Z-2431-202610195327517977, 10198459247972, 10198459697135, 10198459543005, 10198459597466, 10198459044106, 10195327140656, 10198459366871, 10198459583148, 10198459044113, 10198459555206, 10198459634284, 10198459476686, 10198459366949, 10198459563768, 10198459023538, 10198459607172, 10198459443848, 10198459441806
BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A25LBB738, DYNJRA1011A, 25KBB849, 25LBB734Z-2416-202610198459194702, 10888277783614
MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G25LMH070, DYNJ47269D, 25LMJ234, DYNJ63276G, 26BBC598Z-2417-202610195327606527, 10195327674786, 10198459458835
Medline EBSI Kit EBSI15342025110490Z-2414-202610653160350507, 2025110490
Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA271626AMA185, DYNJRA2716, 25KBA971Z-2415-202610198459627330, 10198459567988
Show all 42 products
ProductLot codeRecall #UDI-DI
Medline convenience kits2025103090, EBSI1057A, 2025120890, EBSI1498, 2025110690, EBSI1585, 2025102190, EBSI1621, 2025110390, EBSI1837, 2025102990Z-2438-202610653160382850, 2025103090, 10653160356875, 2025120890, 10193489111538, 2025110690, 10653160354796, 2025102190, 10653160358336, 2025110390, 10653160388555, 2025102990
Medline convenience kits25JBS436Z-2433-202610198459403989
Medline convenience kit25KBB755Z-2427-202610198459409431
Medline convenience kit25KBL873Z-2429-202610198459366390
Medline convenience kits2025102890, EBSI1328A, 2025103090Z-2440-202610653160370130, 2025102890, 10653160382980, 2025103090
Medline convenience kits25KBT972, DYNJ69533C, 26BBC483Z-2432-202610198459268151, 10198459524097
Medline convenience kits26AME511, 26AMG737Z-2420-202610198459293535
Medline convenience kits25LMJ031Z-2447-202610195327024369
Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK DYNJ35761D PACER / CATH LAB PACK-LF DYNJ0972604A PACER CDS CDS983686I PACER PACK DYNJ52059D PK, EP LAB PACEMAKER DYNJ43663A–Z-2444-202610195327512699, 10193489903669, 10195327674755, 10193489902044, 10198459149139, 10195327104542, 10198459224447, 10195327515232, 10195327227340, 10195327565374, 10889942403905, 10193489852981, 10195327361785, 10193489793680, 10193489494983
Medline convenience kits25JBU463, DYNDC3291, 25KBH082Z-2445-202610195327640729, 10195327334741
Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAST AUGMENTATION PACK DYNJ68023 FACIAL PLASTIC DYNJ909926C JVL - MODULE PLASTIC PK DYNJ84081B KIT MAJOR PLASTICS MOSES DYNJ905362C MEM MAXILLOFACIAL PACK-LF DYNJ0660040R MINOR BREAST PACK DYNJ89023A PLASTIC MAJOR SURGERY DYNJ902510M PLASTIC PACK DYNJ84766 PLASTIC PACK-LF DYNJ0578842M PLASTICS EXTREMITY PACK DYNJ63803C PLASTICS PK - NO SYR DYNJ62433D RR-ASC-RH–Z-2423-202610198459517839, 10193489296891, 10193489468083, 10198459423109, 10198459462474, 10198459346842, 10889942220083, 10198459388316, 10198459683374, 10195327414108, 10193489288292, 10198459149825, 10198459498176, 10198459349362, 10198459635182, 10198459388477
Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL LAPAROSCOPY PA DYNJ58305 CHRISTUS CH PEDIATRIC BASIC DYNJ61167G CVC INSERTION BUNDLE CVI3940A DAVINCI PACK SURGICOUNT DYNJ45544F EPCH BASIC PACK DYNJ83094C GENERAL PACK DYNJ39682B DYNJ84882 GENERAL RFD DYNJ906336F GENERAL SURGERY PACK DYNJT6003 GV MACD PACK DYNJ46952M IMPLANT PACK - BBI AR DYNJ63508A KIT THORACOSCOPY DYNJ908872F LVAD TRAY DM1120A MAJOR UROLOGY–Z-2424-202610198459394577, 10198459368967, 10889942843763, 10198459386671, 10653160998976, 10193489876130, 10198459562051, 10193489769241, 10195327432324, 10198459419959, 10198459531255, 10198459090134, 10193489363845, 10198459660306, 10653160998891, 10193489820249, 10198459358562, 10195327694296, 10193489957228, 10889942890170
Medline convenience kits25KBM985, DT13191A, 26AMA168, CDS982047S, 26AMB202, DYNJ62889C, 26AMA584Z-2419-202610198459576294, 10653160998914, 10198459385735, 10198459416453
Medline convenience kits26AMC363, DYNJ68260D, 25KBE168, DYNJ905094B, 25KMB136, CDS820091P, 26BBO404, 26CBN891Z-2446-202610195327412555, 10195327506513, 10193489858174, 10195327403539
Medline convenience kit26CBC731Z-2425-202610653160378518
Medline convenience kits25LBB731Z-2442-202610195327411237
Centurion convenience kits2025102090, DT17570, 2025102290, DT21370B, DT21115B, 2025111490, DYNDC2815A, 2025110590Z-2437-202610653160327271, 2025102090, 10653160266891, 2025102290, 10653160360643, 2025102290, 10653160360681, 2025111490, 10653160357070, 2025110590
Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS CDS983883J BWNBORO LAP CHOLE PACK-LF DYNJ32836B CCSB KARIN JWIRE LUMPECTOMY DYNJ910459B CHRISTUS CHILDRENS LAP CHOLE DYNJ61165G CUH MINOR PACK-LF DYNJ60095B FREE FLAP CUSTOM PACK B DYNJ82736B FREE NIPPLE GRAFT DYNJ911160B GEN MINOR DYNJ900906L GEN SURG LAPAROSCOPY PACK DYNJ55248F GEN SURG MINOR PACK DYNJ69142F GENERAL LAP DYNJ61475A DY–Z-2422-202610195327494728, 10195327662608, 10198459073151, 10198459429798, 10195327037369, 10198459477409, 10198459386701, 10198459413377, 10198459038907, 10198459398001, 10198459408526, 10195327633486, 10198459478499, 10195327605797, 10198459351037, 10198459542992, 10198459460678, 10195327434182, 10198459394591, 10195327692971
Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ85197A DYNJT4007 BASIC ACCESS PACK-LF DYNJ36698B BASIC BACK TRAY DYNJ89037 BASIC PEDI PACK-LF DYNJ0171446I DYNJ0171446J BASIC SPINE DYNJ910915A BREAST PACK DYNJ87587A BREAST PLASTIC PACK DYNJ84482C C SECTION DYNJ49172I CAROTID ENDARTERECTOMY PACK DYNJ48013L CENTRAL LINE PACK-LF DYNJ0220136S CERVICAL FUSION DYNJ908135B CERVICAL SPINE PACK DYNJ53044G C–Z-2441-202610198459146961, 10198459625008, 10198459481994, 10198459217395, 10198459381867, 10198459081811, 10198459229855, 10195327589516, 10198459591754, 10198459424960, 10198459114199, 10198459362491, 10198459042003, 10198459560941, 10198459566073, 10198459586552, 10198459448768, 10198459375996, 10198459096754, 10198459229053
Medline convenience kit25LBB457, DYNJ67267B, 25LBQ732, DYNJ9814630O, 25LBD665, CDS983383L, 25LBC092, DYNJ59397Q, 25LMG049, DYNJT7315, 25LBO095, DYNJ25097I, 25KBC747, DYNJ21925S, 25KBD835, 25LBR371, DYNJT6428, 26AMA602, DYNJ0785736M, 25LMI831, SYNJ10307B, 25LBE309Z-2428-202610198459504273, 10198459084331, 10195327587291, 10198459224577, 10198459495427, 10198459620225, 10198459449550, 10195327105020, 10198459553660, 10198459487149, 10195327007249
Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JEWISH DR SEVERTSON EAR DYNJ909252C JEWISH HEAD&NECK DYNJ909255C KIT HEAD AND NECK MHS DYNJ905364B MAJOR EAR CDS983347S MAJOR EAR FMOL LADY OF THE LAK DYNJ89581 MAJOR EAR PACK DYNJT4872 MAJOR HEAD AND NECK PACK DYNJ38985G MAJOR HEAD NECK PACK DYNJ45706B MZ EAR CDS DYNJ–Z-2421-202610198459440366, 10198459434679, 10198459560354, 10193489979749, 10198459496936, 10198459113444, 10193489806779, 10198459447310, 10198459318726, 10198459210167, 10198459346255, 10198459397370, 10198459278594, 10198459459672, 10195327385682, 10193489856293, 10195327587277, 10198459394775, 10195327523039, 10198459036972
Medline convenience kit25KBK310, 25LBN341Z-2426-202610195327495589
Medline convenience kits26ABB308, 26BBA671, CDS760053K, 25KBP010Z-2435-202610198459549977, 10195327182977
Medline convenience kits2025120890, ECVC8055A, 2025112690, ECVC6915A, 2025102790, ECVC6985B, 2025103190Z-2439-202610653160387428, 2025120890, 10653160387848, 2025112690, 10653160389439, 2025102790, 10653160388272, 2025103190
Medline convenience kits–Z-2443-202610195327027261
Medline convenience kits25KBA098, CDS840150Y, 25JBW220, 26BBD028, DYNJ56297C, 25LMJ874, DYNJT3454, 25KBG761, DYNJ33822L, 26AMA072, DYNJ900962O, 26CBC302, DYNJ54238L, 25LMH549, DYNJT6766, 25KBM870, DYNJ909794C, 25LBF702, CVI5323A, 25KBM758, CDS983040M, 25KBO682, 26BBB926Z-2418-202610198459422133, 10198459303029, 10198459513954, 10198459325663, 10198459385582, 10198459452581, 10198459443114, 10198459580888, 10198459528002, 10198459582035, 10198459579813
Medline convenience kits26DBJ301, DYNJ907336B, 26DBF966, DYNJ910821A, 25KBH623, 26BBL877, 26BBM089, DYNJ81098C, 25JBR783, 25KBD860, DYNJ911996, 25LBI311, 25LBV123, 26ABN955, DYNJ86584B, 25LMH561, DYNJ905281B, 25KBD109, DYNJ67271A, 25JBV609, DYNJ904848L, 26DBK390, DYNJ901355J, 25LBK865, DYNJ908193B, 25LBD958, DYNJ42963M, 26AMB027, DYNJ52268B, 25LBC027, 26CBA143, DYNJ908684A, 26AMH337, CDS983364G, 26BBR233, DYNJT4339, 26CBC179, DYNJ908828D, 25KMC466, 26AMG065 (+173 more, see the official notice)–10195327305024, 10198459084300, 10198459453359, 10198459357107, 10198459596230, 10198459410604, 10195327063191, 10195327626822, 10198459217500, 10198459224775, 10198459521720, 10198459611834, 10195327432423, 10198459500510, 10195327432508, 10198459448720, 10198459512919, 10195327565206, 10195327006532, 10198459559372, 10198459105029, 10195327556389, 10198459631399, 10195327674229, 10195327533694, 10198459410741, 10198459574658, 10195327434151, 10889942807383, 10198459090103, 10195327131449, 10198459132360, 10198459515057, 10889942754014, 10198459285868, 10195327422103, 10198459217579, 10198459206252, 10198459610226, 10198459217586 (+54 more, see the official notice)
Medline convenience kits25KBL478, DYNJ81460C, 25KBE552, DYNJ900004J, 26AMA112, DYNJ901779J, 25LMI890, DYNJ902900F, 25KBA607, DYNJ81419D, 25KBM670, DYNJ40498B, 25KBC776, 25LBO494, DYNJ901246J, 25KBQ989, 26ABI798, 26DBH373, DYNJ909252C, 25JBS227, 25KBC598, 25LBR040, DYNJ909255C, 25LBH411, DYNJ905364B, 25LBM363, 26BBO336, CDS983347S, 26BBC029, 26CBR342, DYNJ89581, 25LBP819, DYNJT4872, 25KBA908, DYNJ38985G, 25JBA164, 25KBG575, DYNJ45706B, 25KBK200, DYNJ905642F (+22 more, see the official notice)–10198459440366, 10198459434679, 10198459560354, 10193489979749, 10198459496936, 10198459113444, 10193489806779, 10198459447310, 10198459318726, 10198459210167, 10198459346255, 10198459397370, 10198459278594, 10198459459672, 10195327385682, 10193489856293, 10195327587277, 10198459394775, 10195327523039, 10198459036972, 10193489953848, 10198459530258, 10195327341640, 10198459105463, 10198459472565, 10198459368028
Medline convenience kits25JBX559, DYNJ68484B, 25LME889, DYNJ58305, 25KBA708, DYNJ61167G, 25KBN904, 25LBQ928, CVI3940A, 26AME675, DYNJ45544F, 25KBJ042, DYNJ83094C, 25JMD330, DYNJ39682B, 25KBI410, 25LBI978, 26BBC735, DYNJ84882, 26CBQ487, DYNJ906336F, 25KBR497, 26CBO946, DYNJT6003, 25JBV850, 26CBC211, DYNJ46952M, 25KBH401, 25LBO238, DYNJ63508A, 26BBC181, DYNJ908872F, 26BBR620, DM1120A, 25KBA425, 25LBJ075, DYNJ0368525M, 25KBG895, 25KBG896, DYNJ911467 (+60 more, see the official notice)–10198459394577, 10198459368967, 10889942843763, 10198459386671, 10653160998976, 10193489876130, 10198459562051, 10193489769241, 10195327432324, 10198459419959, 10198459531255, 10198459090134, 10193489363845, 10198459660306, 10653160998891, 10193489820249, 10198459358562, 10195327694296, 10193489957228, 10889942890170, 10198459513329, 10198459194764, 10195327631413, 10198459419829, 10198459443206, 10198459100260, 10198459615924, 10193489509168, 10198459278723, 10198459402739, 10195327341749, 10198459438844, 10198459358968, 10193489257434, 10198459467967, 10198459533167, 10195327341688, 10198459085499, 10195327027018, 10198459496790 (+2 more, see the official notice)
Medline convenience kits25LBB534, DYNJ905293I, 25KBM585, DYNJT8308, 26CBD040, CDS860087Q, 25JBV094, 25LBP061, DYNJ910084C, 25LBE810, CDS982371I, 25KBH343, 26CBN241, CDS920099S, 25KBO172, DYNJT3887, 25JBX564, DYNJT6876, 25KBM646, CDS984228K, 26ABF608, DYNJ911843, 25LBC203, DYKMBNDL165C, 25LBR024, CDS985442J, 25JBT926, DYNJ84725B, 25JBA329, DYNJ910594B, 25KBJ104, DYNJ53711B, 25KBF929, 25LBB875, DYNJ83622C, 25LBR740, 26CBJ460, DYNJ909322B, 25LBD961, DYNJ902583O (+1 more, see the official notice)–10195327517977, 10198459247972, 10198459697135, 10198459543005, 10198459597466, 10198459044106, 10195327140656, 10198459366871, 10198459583148, 10198459044113, 10198459555206, 10198459634284, 10198459476686, 10198459366949, 10198459563768, 10198459023538, 10198459607172, 10198459443848, 10198459441806
Medline convenience kits26AMA776, DYNJ902515K, 25KBO749, DYNJ904119O, 26ABB899, 26ABI225, 26ABJ235, CDS983883J, 25KBK403, DYNJ32836B, 25LMF151, DYNJ910459B, 26AML096, DYNJ61165G, 25LBO683, 26ABE316, DYNJ60095B, 25KBB960, 25LBO686, DYNJ82736B, 25LMG794, DYNJ911160B, 26AMB749, DYNJ900906L, 26AMG179, DYNJ55248F, 25KBA350, DYNJ69142F, 25LMF407, DYNJ61475A, 25JBT649, DYNJT3759, 25KBJ720, DYNJ61515I, 25KBI633, DYNJT4452, 25JBR785, DYNJ37208D, 25LBJ032, DYNJ905870G (+88 more, see the official notice)–10195327494728, 10195327662608, 10198459073151, 10198459429798, 10195327037369, 10198459477409, 10198459386701, 10198459413377, 10198459038907, 10198459398001, 10198459408526, 10195327633486, 10198459478499, 10195327605797, 10198459351037, 10198459542992, 10198459460678, 10195327434182, 10198459394591, 10195327692971, 10193489852394, 10198459456701, 10193489898514, 10198459597121, 10198459023453, 10198459352539, 10889942826599, 10193489324815, 10198459419850, 10195327006037, 10198459409554, 10195327224547, 10193489273472, 10198459419843, 10198459240218, 10889942881222, 10198459237324, 10198459254789, 10198459438745, 10198459697159 (+18 more, see the official notice)
Medline convenience kits25KBA123, SYNJ10306A, 25LBO305, 26CBD081, DYNJ68023, 25KBI169, DYNJ909926C, 25LBC067, 25LBR659, DYNJ84081B, 25LMI881, DYNJ905362C, 25KBN239, 25LBF694, DYNJ0660040R, 25JME572, 26AMA936, DYNJ89023A, 25KBC500, DYNJ902510M, 26CBM279, 26CBO942, DYNJ84766, 26BBC049, DYNJ0578842M, 25LMG027, DYNJ63803C, 25LBN476, 26CBC156, DYNJ62433D, 25KBC752, 25KBM917, DYNJ81772C, 25LMH594, 25LMI396, DYNJT7588, 26AMA250, DYNJ89048A, 26BBD124–10198459517839, 10193489296891, 10193489468083, 10198459423109, 10198459462474, 10198459346842, 10889942220083, 10198459388316, 10198459683374, 10195327414108, 10193489288292, 10198459149825, 10198459498176, 10198459349362, 10198459635182, 10198459388477
Medline convenience kits25KBH332, DYNJ47103D, 25LMF684, DYNJ67197G, 25JBA258, DYNJ85197A, 25LMF727, DYNJT4007, 26BBC180, DYNJ36698B, 25KBM204, 26CBD413, DYNJ89037, 25KBI083, 25KBM202, DYNJ0171446I, 25JBT239, DYNJ0171446J, 26CBB295, DYNJ910915A, 25LBD596, DYNJ87587A, 25JBR735, DYNJ84482C, 26BBU043, DYNJ49172I, 26AMA388, DYNJ48013L, 25LBP624, DYNJ0220136S, 25LMF648, DYNJ908135B, 25LBC200, 25LBR878, DYNJ53044G, 25LMG369, DYNJ909099F, 25JMF136, DYNJ61711C, 25JBT124 (+148 more, see the official notice)–10198459146961, 10198459625008, 10198459481994, 10198459217395, 10198459381867, 10198459081811, 10198459229855, 10195327589516, 10198459591754, 10198459424960, 10198459114199, 10198459362491, 10198459042003, 10198459560941, 10198459566073, 10198459586552, 10198459448768, 10198459375996, 10198459096754, 10198459229053, 10198459254109, 10198459546792, 10198459169694, 10198459007439, 10198459497551, 10195327549510, 10195327549633, 10198459562068, 10195327697181, 10198459440373, 10198459395321, 10198459185397, 10198459702358, 10195327579661, 10198459591990, 10198459143328, 10198459427985, 10198459366413, 10198459421556, 10198459526107 (+48 more, see the official notice)
Medline convenience kits25LBP470, DYNJ56573B, 25KBK220, DYNJ29135N, 25LMG563, DYNJ65916B, 25KBG852, 25LBB895, CDS983672P, 25LBO027, 26BBB852, DYNJ21877W, 25JBW040, DYNJ39316D, 25KBH774, DYNJ58354F, 25KBI240, DYNJ0618174N, 25KBC715, DYNJ35761D, 26CBC772, DYNJ0972604A, 25LMF965, CDS983686I, 26ABE755, DYNJ52059D, 25LBQ917, 26CBE736, DYNJ43663A, 26CBB662, DYNJ45640B, 25LMJ305–10195327512699, 10193489903669, 10195327674755, 10193489902044, 10198459149139, 10195327104542, 10198459224447, 10195327515232, 10195327227340, 10195327565374, 10889942403905, 10193489852981, 10195327361785, 10193489793680, 10193489494983

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification