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Use caution Medical device recall · FDA · Published March 21, 2024

Boston Scientific Recalls Expo 5F Catheters Due to Guidewire Advancement Issues

Boston Scientific recalls Expo 5F Selective Angiographic Catheters with specific batch numbers due to potential guidewire advancement problems caused by polyurethane layer delamination.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1666-2024Medical deviceBoston Scientific ›
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Recalling firmBoston Scientific Corporation1 Scimed Pl · Maple Grove, MN 55311-1565
✎ GovInfoNow plain-language explainer

Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Catheters because some units may have polyurethane layers that delaminate, making it difficult to advance guidewires. This could lead to complications during cardiac catheter procedures. Read more at govinfonow.com/recall/55744-boston-scientific-recalls-expo-5f-catheters-due-to-guidewire-advancement.

Source Summary by GovInfoNow · govinfonow.com/recall/55744-boston-scientific-recalls-expo-5f-catheters-due-to-guidewire-advancement · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1666-2024

Cite this page

“Boston Scientific Recalls Expo 5F Catheters Due to Guidewire Advancement Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55744-boston-scientific-recalls-expo-5f-catheters-due-to-guidewire-advancement. Based on FDA recall #Z-1666-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1666-2024%22&limit=1).

The FDA announced on March 21, 2024, that Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters due to potential guidewire advancement issues. The agency classified the recall as Class I.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: Expo 5F Selective Angiographic Catheters
  • Model: 5F EXPO MULTIPACK (5PKX3)
  • REF: H749085263002
  • UDI/DI: 08714729187868
  • Batch Numbers: 60427727, 60456253, 60462030, 60476271, 60500758, 60530055, 60436627, 60460188, 60474027, 60477271, 60502673, 60537578, 60438198, 60461419, 60475349, 60486289, 60515228

The hazard

According to the FDA, there is an increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls of similar products include Soft-Vu Angiographic Catheter Recall (March 3, 2026), Angiodynamics Soft-Vu Catheter Recall (March 3, 2026) and Angiodynamics AccuVu Catheter Recall (March 3, 2026).

How to tell if you have this one

Check for batch numbers: 60427727, 60456253, 60462030, 60476271, 60500758, 60530055, 60436627, 60460188, 60474027, 60477271, 60502673, 60537578, 60438198, 60461419, 60475349, 60486289, 60515228. The product is a cardiac catheter with model number 5F EXPO MULTIPACK (5PKX3).

  • Brand
    Boston Scientific
  • Category
    Medical device
FDA recall event · 48 products

All 48 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
Recall numberProduct, codes & lotsQuantity
Z-1638-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter; UDI/DI 08714729187684, Batch Numbers: 60425778, 60427745, 60438674, 60456279, 60465785, 60476456, 60427256, 60430877, 60440972, 60465783, 60472599, 60479447, 60427594, 60430933, 60449235, 60465784, 60474047, 60479448, 60474048, 6052258816797 catheters
Z-1639-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter; UDI/DI 08714729187691, Batch Numbers: 60423767, 60436637, 60449962, 60467488, 60481586, 60500723, 60423768, 60438203, 60449964, 60467118, 60481588, 60500724, 60423772, 60438204, 60449961, 60467489, 60482882, 60500725, 60425130, 60436635, 60453707, 60469085, 60482883, 60500726, 60425128, 60438654, 60457132, 60472566, 60482881, 60500728, 60425129, 60438652, 60456262, 60473138, 60483867, 60500727, 60425763, 60438653, 60461405, 60474065, 60483868, 60504878, 60425764, 60440739, 60461406, 60474066, 60483869, 60504879, 60425765, 60440950, 60461408, 60474067, 60483870, 60504880, 60427255, 60442609, 60461407, 60474068, 60483872, 60512235, 60427593, 60442607, 60463410, 60474069, 60483858, 60519446, 60427715, 60443038, 60463411, 60474070, 60483871, 60519447, 60427716, 60443909, 60463956, 60474071, 60485566, 60519448, 60427717, 60445389, 60463957, 60474013, 60486069, 60519445, 60427720, 60445901, 60463958, 60474015, 60486070, 60521830, 60427718, 60445902, 60463407, 60476442, 60487589, 60521831, 60430441, 60445910, 60463409, 60476145, 60487590, 60522905, 60430885, 60445913, 60463408, 60476146, 60487591, 60522903, 60430914, 60445899, 60463959, 60476147, 60487592, 60522904, 60432697, 60445912, 60463960, 60476148, 60487593, 60525055, 60432698, 60445900, 60463961, 60476149, 60488284, 60525056, 60432699, 60445909, 60464366, 60479441, 60488286, 60525058, 60432700, 60445911, 60464367, 60479442, 60488287, 60523275, 60432714, 60445903, 60465466, 60479443, 60488285, 60525078, 60433871, 60449229, 60464440, 60479444, 60492194, 60526117, 60433882, 60449230, 60464441, 60479445, 60492195, 60526118, 60437043, 60449236, 60467115, 60479446, 60492196, 60526119, 60437781, 60449963, 60467117, 60481587, 60492197, 60526189, 60437780, 60449958, 60467119, 60481583, 60493940, 60526190, 60438205, 60449959, 60467116, 60481584, 60493941, 60526191, 60438502, 60449960, 60467490, 60481585, 60495538, 60526120, 60495539, 60526121297479 catheters
Z-1640-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter; UDI/DI 08714729366478, Batch Numbers: 604669210
Z-1641-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter; UDI/DI 08714729187707, Batch Numbers: 60429295, 60452070, 60467044, 60475390, 60491910, 60525061, 60430929, 60459221, 60472581, 60483688, 60498233, 60530044, 60512378, 60536198,15079 catheters
Z-1642-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter; UDI/DI 08714729187714, Batch Numbers: 60493978, 60530035290 catheters
Z-1643-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter; UDI/DI 08714729248705, Batch Numbers: 60448979, 60500188, 60535893385 catheters
Z-1644-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter; UDI/DI 08714729187721, Batch Numbers: 60448983, 60461410, 60476253, 60486049, 605173151465 catheters
Z-1645-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheter; UDI/DI 08714729187776, Batch Numbers: 60447174120 catheters
Z-1646-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter; UDI/DI 08714729249030, Batch Numbers: 60504831, 60515598, 60533629230 catheters
Z-1647-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter; UDI/DI 08714729168928, Batch Numbers: 60447160, 60463413, 60472609, 60481602, 60493975, 60517338, 60511235, 605335883127 catheters
Z-1648-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter; UDI/DI 08714729187790, Batch Numbers: 60443926, 60463398, 60472605, 60473187, 60498234, 60524982, 60513387, 60533587, 605358755510 catheters
Z-1649-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter; UDI/DI 08714729187806, Batch Numbers: 60432320, 60447145, 60468840, 60491659, 60515603, 60523996, 60438675, 60459197, 60475371, 60495554, 60522591, 60533644, 60440974, 60467093, 60483661, 60504885, 60522595, 6053619725617 catheters
Z-1650-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter; UDI/DI 08714729249191, Batch Numbers: 60447151, 60456265, 60472610, 60486304, 60522592, 605314322366 catheters
Z-1651-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter; UDI/DI 08714729249214, Batch Numbers: 60448987, 60467091, 60476275, 60486323, 605358941170 catheters
Z-1652-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter; UDI/DI 08714729376675, Batch Numbers: 60433909, 60459200, 60467047, 60486322, 60504866, 60533642, 60447140, 60463976, 60474043, 60504859, 605173308725 catheters
Z-1653-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter; UDI/DI 08714729187813, Batch Numbers: 60423725, 60438648, 60449984, 60474078, 60488293, 60507284, 60427729, 60438649, 60453725, 60474079, 60490173, 60507287, 60427730, 60440943, 60453726, 60474080, 60490174, 60507479, 60427731, 60440944, 60461414, 60475372, 60490175, 60507660, 60427732, 60440945, 60461429, 60475376, 60490176, 60507661, 60427733, 60440946, 60536188, 60475377, 60490177, 60507662, 60427734, 60440947, 60463596, 60475378, 60490178, 60507663, 60430886, 60443002, 60463598, 60475379, 60490179, 60511641, 60430922, 60443027, 60463962, 60476443, 60491458, 60511642, 60430923, 60443028, 60463972, 60476444, 60491465, 60511643, 60430925, 60443029, 60463973, 60477294, 60491466, 60511644, 60432701, 60443030, 60464490, 60477295, 60491467, 60515578, 60432702, 60443031, 60464491, 60477296, 60493944, 60515579, 60432716, 60443897, 60467016, 60477297, 60495540, 60515580, 60432719, 60443898, 60467017, 60479452, 60495541, 60517602, 60433872, 60443899, 60467018, 60479453, 60495542, 60517603, 60433875, 60443900, 60467019, 60479454, 60495543, 60517604, 60433885, 60443901, 60467020, 60479455, 60495544, 60517607, 60433886, 60443902, 60469093, 60481591, 60495545, 60522510263522 catheters
Z-1654-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202; cardiac catheter; UDI/DI 08714729007531, Batch Numbers: 60438212, 60449780, 60491491, 60491959, 605218282990 catheters
Z-1655-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter; UDI/DI 08714729187820, Batch Numbers: 60427721, 60437784, 60456288, 60473154, 60481598, 60500737, 60427722, 60443032, 60461431, 60473157, 60481599, 60505121, 60427723, 60443033, 60462014, 60474023, 60481600, 60512236, 60427724, 60443034, 60463401, 60474083, 60481601, 60512384, 60427725, 60443035, 60463402, 60474084, 60488294, 60512385, 60427726, 60443036, 60463600, 60474085, 60488295, 60521834, 60430878, 60443903, 60463954, 60476445, 60488296, 60521835, 60430926, 60443904, 60463955, 60477256, 60488297, 60521836, 60430927, 60443905, 60463967, 60479456, 60488298, 60522587, 60430928, 60443906, 60463974, 60479457, 60492673, 60522901, 60432308, 60443907, 60464492, 60479458, 60492674, 60522902, 60432309, 60446725, 60470527, 60479459, 60492675, 60525059, 60432310, 60448203, 60470528, 60479460, 60492676, 60525077, 60434240, 60448204, 60470530, 60479461, 60492677, 60527362, 60434481, 60448205, 60470531, 60481596, 60498229, 60527363, 60436641, 60452064, 60472576, 60481597, 60498230, 60533639, 60538215116091 catheters
Z-1656-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter; UDI/DI 08714729192817, Batch Numbers: 60430691, 60447156, 60463406, 60488300, 60493468, 605375135435 catheters
Z-1657-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter; UDI/DI 08714729007562, Batch Numbers: 60449785, 60491507, 60537491330 catheters
Z-1658-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter; UDI/DI 08714729187837, Batch Numbers: 60443928, 60457123, 60464496, 60473188, 60504888, 60522597, 60477305, 60517337, 605335894715 catheters
Z-1659-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter; UDI/DI 08714729007579, Batch Numbers: 6053358215 catheters
Z-1660-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter; UDI/DI 08714729007593, Batch Numbers: 60444872, 60451459, 60451968, 605112201065 catheters
Z-1661-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter; UDI/DI 08714729886082, Batch Numbers: 60447162, 60461412, 60474054, 60486303, 60495529, 60511248, 60511234, 605314354270 catheters
Z-1662-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter; UDI/DI 08714729187851, Batch Numbers: 60447163, 60464498, 60485991, 60515607, 60517314, 605335831669 catheters
Z-1663-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter; UDI/DI 08714729886129, Batch Numbers: 605358900
Z-1664-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter; UDI/DI 08714729886143, Batch Numbers: 60500256, 6053621010 catheters
Z-1665-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter; UDI/DI 08714729521501, Batch Numbers: 60443927, 60495422363 catheters
Z-1666-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter; UDI/DI 08714729187868, Batch Numbers: 60427727, 60456253, 60462030, 60476271, 60500758, 60530055, 60436627, 60460188, 60474027, 60477271, 60502673, 60537578, 60438198, 60461419, 60475349, 60486289, 6051522846860 catheters
Z-1667-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter; UDI/DI 08714729521518, Batch Numbers: 60451436, 60470651, 60490172, 60495478847 catheters
Z-1668-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter; UDI/DI 08714729187875, Batch Numbers: 60422723, 60442593, 60463980, 60477215, 60490182, 60504886, 60422730, 60442594, 60463981, 60477318, 60496717, 60509543, 60423803, 60449237, 60465461, 60478140, 60498231, 60532101, 60423804, 60452059, 60470647, 60480055, 60500299, 60532102, 60438197, 60453695, 60472578, 60486055, 60500755, 60536194, 60438657, 60456291, 60476246, 60486317, 60500756, 60536195, 60438658, 60459250, 60476454, 60490180, 60500757, 60536196, 60440954, 60463066, 60477214, 60490181, 6050267186898 catheters
Z-1669-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter; UDI/DI 08714729187882, Batch Numbers: 60447157, 60462032, 60480056, 60493500, 60524948, 60447158, 60477290, 60480062, 60504860, 6053359215270 catheters
Z-1670-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter; UDI/DI 08714729249382, Batch Numbers: 60480059105 catheters
Z-1671-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter; UDI/DI 08714729249399, Batch Numbers: 60429298, 60451469, 60459243, 60481409, 60535930, 60434211, 60454956, 60463953, 60490141, 60535931, 60436616, 60459198, 60463979, 60517312, 605362042314 catheters
Z-1672-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter; UDI/DI 08714729249412, Batch Numbers: 60437054, 60447182, 60463964, 60477273, 60488498, 60495556, 60437063, 60447183, 60465472, 60481568, 60488499, 60497690, 60437064, 60448980, 60465473, 60483603, 60488500, 60507240, 60438200, 60448981, 60465481, 60483604, 60490167, 60507657, 60438201, 60448982, 60465482, 60483634, 60490169, 60507658, 60438202, 60454958, 60465483, 60483635, 60490170, 60507659, 60445390, 60460144, 60474107, 60483638, 60490171, 60517310, 60447181, 60463963, 60474501, 60488390, 60491660, 60517311, 60488497, 60491661, 60530050, 60495555, 6053821923529 catheters
Z-1673-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter; UDI/DI 08714729249429, Batch Numbers: 60447165, 60490140, 604901831950 catheters
Z-1674-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter; UDI/DI 08714729249498, Batch Numbers: 60442598, 60442599, 60448185, 60459199, 60488391, 60490138, 60451431, 60467097, 60490137, 604901681322 catheters
Z-1675-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter; UDI/DI 08714729249504, Batch Numbers: 60442603, 60448206, 60463966, 60481407, 60491911, 60492607, 60443053, 60457140, 60467045, 60485945, 60492554, 60492608, 60443054, 60457142, 60467046, 60488392, 60492605, 60448186, 60463965, 60481406, 60488393, 604926068575 catheters
Z-1676-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter; UDI/DI 08714729812166, Batch Numbers: 60468842440 catheters
Z-1677-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; cardiac catheter; UDI/DI 08714729812180, Batch Numbers: 60436618, 60477262, 60477325, 60535891, 605404871015 catheters
Z-1678-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter; UDI/DI 08714729812203, Batch Numbers: 60447147, 60467099, 60492626615 catheters
Z-1679-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter; UDI/DI 08714729812227, Batch Numbers: 6044261495 catheters
Z-1680-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter; UDI/DI 08714729187929, Batch Numbers: 60425143, 60448984, 60474111, 60482880, 60525062, 60427595, 60448985, 60477260, 60502674, 60530043, 60429297, 60463971, 60479435, 60511249, 6053620511109 catheters
Z-1681-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter; UDI/DI 08714729168874, Batch Numbers: 60430930, 60447169, 60462004, 60475385, 60515237, 60525060, 60447168, 60461420, 60474038, 60486305, 60522598, 60531431, 605401769271 catheters
Z-1682-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter; UDI/DI 08714729007692, Batch Numbers: 60443056, 60452071, 60464497, 60467054, 60475380, 60511251, 60498235, 605335904942 catheters
Z-1683-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter; UDI/DI 08714729187936, Batch Numbers: 60438199, 60453733, 60472577, 60486300, 60500754, 60513563, 60438660, 60459203, 60473158, 60491662, 60507655, 60529457, 60440956, 60465786, 60477280, 60495526, 60507656, 60533641, 60445923, 60465788, 60477281, 60495527, 60511179, 60538216, 60448986, 60467041, 60477282, 60498225, 60511181, 60538217, 60449233, 60467087, 60486299, 60498226, 6051237737252 catheters
Z-1684-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter; UDI/DI 08714729187943, Batch Numbers: 60434245, 60454961, 60477302, 60510080, 60536207, 60447166, 60474029, 60483669, 60533638, 605404818715 catheters
Z-1685-2024Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter; UDI/DI 08714729187844, Batch Numbers: 60432312, 60448988, 60448989, 60459201, 60464505, 60465484, 60467102, 60467103, 60467104, 60467105, 60467106, 60467107, 60467121, 60469088, 60477210, 60477211, 60477213, 60479437, 60479438, 60481581, 604815828579 catheters
Based on the official FDA remedy

What to do — step by step

  1. Check Batch Numbers

    Look for batch numbers: 60427727, 60456253, 60462030, 60476271, 60500758, 60530055, 60436627, 60460188, 60474027, 60477271, 60502673, 60537578, 60438198, 60461419, 60475349, 60486289, 60515228.

How this recall unfolded

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Mar 21, 202412. FDA classified it Class I: May 10, 202423. Published in FDA’s Enforcement Report: May 22, 202432024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1666-2024 (March 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1666-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA