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Use caution Medical device recall · FDA · Published July 31, 2024

Medtronic MiniMed Insulin Pumps with Battery Issues: Risk of Unexpected Shutdown

Medtronic recalls certain MiniMed insulin pumps that may experience reduced battery life and shortened low battery alerts after being dropped or bumped, potentially causing unexpected shutdowns and insulin delivery interruptions.

🇺🇸 FDA recall #Z-0002-2025Medical deviceMedtronic ›
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Recalling firmMedtronic MiniMed, Inc.18000 Devonshire St · Northridge, CA 91325-1219
✎ GovInfoNow plain-language explainer

Medtronic is recalling specific models of MiniMed insulin pumps that may have internal electrical damage from drops or bumps. This can cause shorter battery life and misleading low battery alerts, increasing the risk of unexpected device shutdowns and insulin delivery interruptions. The issue does not require battery replacement to fix. Read more at govinfonow.com/recall/54373-medtronic-minimed-insulin-pumps-with-battery-issues-risk-of-unexpected.

Source Summary by GovInfoNow · govinfonow.com/recall/54373-medtronic-minimed-insulin-pumps-with-battery-issues-risk-of-unexpected · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0002-2025

Cite this page

“Medtronic MiniMed Insulin Pumps with Battery Issues: Risk of Unexpected Shutdown.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54373-medtronic-minimed-insulin-pumps-with-battery-issues-risk-of-unexpected. Based on FDA recall #Z-0002-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0002-2025%22&limit=1).

The FDA announced on July 31, 2024, that Medtronic MiniMed is recalling MiniMed 620G, 630G, 640G, 720G and 740G insulin pumps due to a defect that may cause reduced battery life. Owners should contact Medtronic for replacement units. The agency classified the recall as Class I.

How to tell if you have it

  • MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750
  • MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755
  • MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752
  • MiniMed 720G Insulin Pump, REF: MMT-1809, MMT-1810, MMT-1817, MMT-1818, MMT-1859, MMT-1860, MMT-1867, MMT-1868
  • MiniMed 740G Insulin Pump, REF: MMT-1811, MMT-1812, MMT-1861, MMT-1862

The hazard

The FDA said pumps that have been dropped or bumped may suffer damage to internal electrical components, leading to shortened battery life and truncated low-battery alerts. This defect can cause the device to power down unexpectedly and stop insulin delivery, potentially resulting in hyperglycemia or diabetic ketoacidosis. The agency noted that patient reports indicate the time between the low battery alert and shutdown could be as short as 2.5 hours.

Context

GovInfoNow's records show Medtronic MiniMed has issued 13 other recalls since November 15, 2023. Recent brand recalls include a July 13, 2026, recall of the MiniMed 670G Insulin Pump for risk of incorrect delivery and a June 16, 2026, recall regarding the MiniMed Go App potentially causing missed doses. Other recent recalls of similar products include an Omnipod DASH Pod Recall (May 20, 2026), an Omnipod 5 Pods Recall (March 12, 2026), and a Fresenius Kabi Ivenix Infusion System Software Recall (May 6, 2026).

How to tell if you have this one

Check if your pump has a model number starting with MiniMed 620G, 630G, 640G, 720G, or 740G with the specific reference codes (MMT-1510, MMT-1710, etc.) listed in the recall. Also check the serial number on the pump or its packaging.

  • Brand
    Medtronic
  • Category
    Medical device
FDA recall event · 3 products

All 3 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
    US: CT, MI, PA, WA, IA, NY, ND, AZ, TX, OH, NC, AL, MN, IN, NJ, KY, UT, CA, FL, VA, MS, NM, NV, TN, GA, MA, NH, OK, VT, IL, ME, SC, LA, WY, RI, SD, KS, WI, MD, CO, DE, AR, AK, ID, MO, NE, WV, MT, OR, DC, HI, VI, PR. OUS: Worldwide
Recall numberProduct, codes & lotsQuantity
Z-0001-2025MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851; REF/UDI-DI(GTIN): MMT-1714/00643169782396, 00763000253059; MMT-1715/00643169873841, 00763000190446, 00643169752726, 643169873834, 00763000317591, 00763000316655, 763000367053, 763000316655, 76300031665503, 763000190439, 763000316631, 763000166519, 763000072520, 76300031665501, 763000256807, 763000090197, 643169656840, 763000316686, 00643169656840, 00763000090197, 00763000190439, 00763000316631; MMT-1755/643169752726, 643169873841, 763000190446, 763000101527, 763000317591, 00763000317591, 763000367091, 763000179632, 763000317621, 643169878648, 763000157043, 76300031759103, 00643169752726, 76300031759101, 76300031762103, 76300031762101, 00763000101527, 00763000190446; MMT-1801/00763000531157; MMT-1805/00763000561680; MMT-1850/00763000552541; MMT-1851/00763000854737, 00763000541323. All serial numbers.24,595
Z-0002-2025MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G Insulin Pump, REF: MMT-1809, MMT-1810, MMT-1817, MMT-1818, MMT-1859, MMT-1860, MMT-1867, MMT-1868 MiniMed 740G Insulin Pump, REF: MMT-1811, MMT-1812, MMT-1861, MMT-1862; REF/UDI-DI(GTIN): MMT-1710/00643169568419; MMT-1750/00763000253189, 00763000375461, 00643169721319, 00643169559745, 763000253189; MMT-1714/00763000253059, 00763000074845, 00643169782396, 763000253059, 643169782396; MMT-1715/ 00763000316631, 763000190439, 763000316631; MMT-1754/00763000253066, 00643169976344, 00763000315719, 00763000381912, 763000253066; MMT-1755/643169752726, 643169873841, 763000190446, 763000101527, 763000317591, 00763000317591, 763000367091, 763000179632, 763000317621, 643169878648, 763000157043, 76300031759103, 00643169752726, 76300031759101, 76300031762103, 76300031762101, 00763000101527, 00763000190446; MMT-1711/00643169662568, 00763000317119, 00763000317089, 00763000404550, 00763000367039, 00763000317102, 00643169662544, 00643169739468, 00643169554931, 00763000192136, 00763000068998, 00763000198596, 00643169662575, 00763000065195, 00763000258337, 00643169999763, 00643169739451, 00643169739475, 00643169739444, 00643169739482, 00763000192211, 00643169729353, 00643169554924, 00763000013066, 00643169554948, 00643169554917, 00643169966284, 00643169629813, 00643169662582, 00643169554955, 00643169966277, 00643169966260, 00643169966307, 00643169966291, 00643169662551, 643169890039, 763000367039, 763000317089, 763000192211, 763000317119, 643169739444, 643169554931, 643169739468; MMT-1712/00763000367046, 00763000317157, 00763000317195, 00763000404567, 00763000192143, 00763000317188, 00763000317140, 00763000065201, 00763000317164, 00643169739512, 00763000069001, 00763000258344, 00643169662636, 00643169999770, 00643169577664, 00763000155346, 00763000198602, 00763000192228, 00643169729360, 00643169739499, 00643169739505, 00643169577688, 00643169739536, 00643169662612, 00643169739529, 00643169629820, 00643169577701, 00643169662599, 00643169577695, 00643169966338, 00643169966352, 00643169966314, 00643169966321, 00643169577671, 00643169662629, 00643169662605, 00643169966345, 763000317195, 763000317140, 763000192228, 643169739512, 643169577688, 643169999770, 763000317157, 763000367046, 643169739505; MMT-1751/00763000194246, 00763000319489, 00763000319359, 00763000319410, 00763000319458, 00763000319519, 00643169521179, 00763000324698, 00763000319366, 00763000194338, 00763000319434, 00763000319533, 00763000324681, 00643169999787, 00763000319380, 00763000319427, 00763000319526, 00763000402686, 00763000319397, 00763000015534, 00763000319342, 00763000402693, 00763000192198, 00763000319373, 00763000319496, 00763000194291, 00643169672239, 00763000002855, 00763000402709, 00763000194352, 00763000015558, 00763000002787, 00763000253288, 00763000165185, 00763000165123, 00643169682849, 00763000015510, 00763000319441, 00643169672253, 00763000319403, 00763000165109, 00763000015480, 00643169683143, 00763000194314, 00643169672246, 00763000194475, 00763000165130, 00763000165154, 00763000083441, 00763000165093, 00763000165116, 00763000165147, 00763000074814, 00763000194345, 00763000194277, 00763000165222, 00763000194307, 00763000165215, 00763000002824, 00643169682245, 00643169682603, 00763000194239, 00763000194253, 00763000194321, 00763000194222, 00643169682269, 00763000002817, 00643169682061, 00763000194260, 00763000015572, 00763000002831, 00643169682337, 00763000015497, 00763000002763, 00643169682085, 00763000015589, 00643169585270, 00763000015503, 00763000015596, 00643169683129, 00643169672277, 00643169522046, 00763000015541, 00763000015565, 00643169682313, 00643169643680, 00643169643413, 00643169682535, 00643169682801, 00643169681996, 00643169521995, 00643169521445, 00643169585294, 00643169682054, 00643169682047, 00643169672260, 00763000002770, 00763000002848, 00763000002879, 00763000002886, 00763000002756, 00643169522060, 00643169682870, 00763000002794, 00763000015459, 00763000002800, 00643169521247, 00643169585256, 00763000002862, 00643169683075, 00643169682351, 00643169522022, 00643169629653, 00643169643710, 00643169682894, 00643169682641, 00643169682009, 00643169682108, 00643169681972, 00643169682627, 00643169683181, 00643169682580, 00643169683167, 00643169682566, 00643169682832, 00643169682023, 00643169682016, 00643169682252, 00643169682917, 00643169682375, 00643169681989, 00643169682078, 00643169683136, 00643169682276, 00643169682030, 00643169682511, 00643169682788, 00643169683051, 00643169682856, 00643169682795, 00643169644274, 00643169643444, 00643169682306, 00643169643482, 00643169683068, 00643169682818, 00643169521520, 00643169643758, 00643169629691, 00643169629677, 00643169643666, 00643169683082, 00643169683105, 00643169682290, 00643169521797, 00643169682825, 00643169682542, 00643169682559, 00643169683099, 00643169521209, 00643169682283, 00643169643956, 00643169643772, 00643169629660, 00643169682528, 00643169521728, 00643169629684, 00643169521544, 00643169644205, 00643169643529, 00643169643505, 00643169521155, 00643169644021, 00643169643468, 00643169644298, 00643169644335, 00643169643987, 00643169644007, 00643169644229, 00643169522084, 00643169521261, 00643169521810, 00643169643390, 00643169521421, 00643169644250, 00643169521568, 00643169643963, 00643169643932, 00643169644045, 00643169521438, 00643169521506, 00643169643734, 00643169521162, 00643169643703, 00643169644236, 00643169643741, 00643169521704, 00643169521476, 00643169644281, 00643169521988, 00643169644243, 00643169521285, 00643169521773, 00643169521971, 00643169522107, 00643169643949, 00643169643697, 00643169521834, 00643169643420, 00643169521223, 00643169643512, 00643169522008, 00643169585287, 00643169521216, 00643169521186, 00643169522015, 00643169521759, 00643169521193, 00643169522053, 00643169521742, 00643169521230, 00643169521780, 00643169521513, 00643169521766, 00643169521469, 00643169585263, 00643169521254, 00643169522077, 00643169521537, 00643169521803, 00643169521711, 00643169643123, 00643169520967, 00643169643253, 00643169520882, 00643169520905, 00643169643208, 00643169643192, 00643169520950, 00643169643178, 00643169643130, 00643169643215, 00643169643154, 00643169643161, 00643169643147, 00643169520974, 00643169520912, 00643169520929, 00643169521018, 00643169520998, 00643169643185, 00643169520943, 00643169520936, 00643169520981, 00643169520899, 00643169643239, 00643169643222, 00643169668829, 00643169574410, 00643169574441, 00643169574434, 00643169574427, 00643169574458, 00643169521735, 00643169521452, 00763000316525; MMT-1752/00763000102593, 00763000318307, 00763000393809, 00643169682474, 00643169682382, 00763000194666, 00763000324704, 00763000194444, 00763000165277, 00763000194383, 00763000319571, 00763000165246, 00763000115968, 00643169521339, 00763000319540, 00763000319274, 00763000194468, 00763000319564, 00763000192204, 00763000318291, 00643169682412, 00763000194451, 00763000165307, 00643169682436, 00763000194390, 00643169643574, 00763000194376, 00643169643581, 00643169521346, 00763000165345, 00763000319618, 00763000319311, 00763000319267, 00763000194369, 00763000165284, 00763000319243, 00763000165338, 00763000319304, 00763000165260, 00763000074821, 00763000194413, 00763000319595, 00763000194406, 00643169682429, 00763000319328, 00763000194420, 00763000319298, 00763000165314, 00763000319557, 00763000319229, 00643169682498, 00763000319588, 00643169999800, 00763000194437, 00643169643628, 00643169521384, 00643169721289, 00643169521292, 00643169643642, 00643169682405, 00643169682443, 00643169521360, 00643169596443, 00643169682450, 00643169596405, 00643169643536, 00643169596382, 00643169521315, 00643169521407, 00643169643567, 00643169643598, 00643169643550, 00643169522305, 00643169521322, 00643169521353, 00643169643260, 00643169643352, 00643169643895, 00643169521612, 00643169521667, 00643169521896, 00643169644120, 00643169644113, 00643169644076, 00643169643314, 00643169643307, 00643169521025, 00643169643802, 00643169644397, 00643169522152, 00643169521117, 00643169644434, 00643169644342, 00643169643871, 00643169644380, 00643169522114, 00643169521049, 00643169521063, 00643169552388, 00643169521872, 00643169521087, 00643169521629, 00643169521575, 00643169522169, 00643169522176, 00643169522145, 00643169643321, 00643169521681, 00643169522138, 00643169521070, 00643169521889, 00643169521841, 00643169521865, 00643169521131, 00643169522206, 00643169521933, 00643169643840, 00643169521605, 00643169521957, 00643169643857, 00643169643864, 00643169644373, 00643169643291, 00643169644182, 00643169643826, 00643169643338, 00643169644168, 00643169644458, 00643169643918, 00643169643833, 00643169644106, 00643169643376, 00643169644410, 00643169644403, 00643169682115, 00643169682153, 00643169683013, 00643169682924, 00643169682962, 00643169682160, 00643169682658, 00643169682696, 00643169683198, 00643169683242, 00643169683280, 00643169683303, 00643169682221, 00643169682207, 00643169682146, 00643169682979, 00643169682184, 00643169682177, 00643169682764, 00643169682702, 00643169682740, 00643169682672, 00643169683235, 00643169683228, 00643169682139, 00643169682955, 00643169683211, 00643169683037, 00643169682948, 00643169683266, 00643169682993, 00643169682689, 00643169682719, 00643169682214, 00643169683259, 00643169682986, 00643169682191, 00763000002633, 00763000002749, 00643169966246, 00763000002671, 00763000002664, 00763000002725, 00643169966253, 00643169668874, 00763000002732, 00763000002695, 00763000002688, 00763000002657, 00643169999817, 00763000002701, 00763000002718, 00763000002640, 00763000015381, 00763000015367, 00763000015435, 00763000015336, 00763000015374, 00763000015398, 00763000015411, 00763000015428, 00763000015350, 00763000015343, 00763000015404, 00763000015442, 00763000069025, 00763000319281, 00763000347536, 00643169521902, 00643169521636, 00643169521056, 00643169522183, 00643169521094, 00643169522381, 00643169522268, 00643169522343, 00643169521100, 00643169521919, 00643169521599, 00643169521643, 00763000319236, 763000255633; MMT-1809/00763000484644, 00763000541330, 00763000769413; MMT-1810/00763000484651, 00763000541347, 00763000769420, 00763000496302; MMT-1859/00763000505196, 00763000505257, 00763000505219, 00763000505318, 00763000505226, 00763000505288, 00763000505271, 00763000505233, 00763000505295; MMT-1860/00763000505387, 00763000505332, 00763000505370, 00763000531171, 00763000505394, 00763000505400, 00763000854768, 00763000505356, 00763000505349, 00763000505325; MMT-1867/00763000638016; MMT-1811/00763000629984, 00763000769451; MMT-1812/00763000484637, 00763000629991, 00763000769468; MMT-1861/00763000504922, 00763000504977, 00763000559557, 00763000504915, 00763000505028, 00763000504960, 00763000504984, 00763000504892, 00763000504861, 00763000504991, 00763000504953, 00763000504908, 00763000504946, 00763000505042, 00763000505004, 00763000505059, 00763000851224, 00763000851217, 00763000504939, 00763000504878; MMT-1862/00763000505080, 00763000505127, 00763000505110, 00763000505158, 00763000505172, 00763000505073, 00763000505066, 00763000505134, 00763000505103, 00763000505189, 00763000505141, 00763000505097, 00763000505165. All serial numbers.234,360
Z-0003-2025MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 780G, REF: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896; REF/UDI-DI(GTIN): MMT-1780/00763000190453, 00643169946057, 00763000365882, 00763000096984, 00763000283445, 763000283513, 763000283506, 763000365882, 763000283520, 76300028351303, 763000393786, 763000166526, 76300028351301, 643169939202, 763000190460, 763000090203, 763000256821, 643169939219, 763000072537, 763000365912, 00763000090203, 00763000190460, 00763000283520, 00763000393786; MMT-1781/00763000187415, 00763000283568, 00763000283544, 00763000404536, 00763000283551, 00763000283537, 00763000365899, 00763000371937, 00763000225575, 00763000225582, 00763000235765, 00763000187378, 00763000140601, 763000240707, 763000187378, 763000140601, 763000283544; MMT-1782/00763000187422, 00763000235772, 00763000283599, 00763000264727, 00763000404543, 00763000283582, 00763000371944, 00763000365905, 00763000283575, 00643169957640, 00763000157463, 00763000225612, 763000225629, 763000225612, 763000264727; MMT-1741/00763000408916, 00763000408930; MMT-1742/00763000408947, 00763000250232, 00763000408954; MMT-1760/763000278427, 763000283445, 643169946057, 763000190453, 763000096984, 643169946040, 00643169946057, 00763000190453, 00763000283445, 763000367084, 763000179649, 763000395858, 00763000096984; MMT-1761/763000187392, 00763000165451, 00763000165420, 00763000165468, 00763000165444, 00763000165437, 00763000257309, 00763000165413, 00763000289065, 00763000289089, 00763000289041, 00763000367657, 00763000289195, 00763000289096, 00763000289072, 00763000289058, 00763000324797, 00763000374518, 00763000374532, 00763000374525, 00763000374556, 00763000399849, 00763000399856, 00763000374587, 763000367657; MMT-1762/763000264710, 00763000264710, 00763000165475, 00763000165482, 00763000165499, 00763000165505, 00763000165512, 00763000165529, 00763000165536, 00763000165543, 00763000165550, 00763000203313, 00763000216481, 00763000252076, 00763000283476, 00763000289102, 00763000289119, 00763000289126, 00763000289133, 00763000289140, 00763000289164, 00763000289171, 00763000289188, 00763000324780, 00763000374594, 00763000374600, 00763000374624, 00763000399986; MMT-1880/00763000414344, 00763000545604, 00763000439859, 763000578640, 763000586195, 76300058619502, 763000439866, 763000413750, 76300057864002, 763000414344, 763000545604, 763000640095, 763000439859, 76300058619501, 00763000413750, 00763000586188; MMT-1881/00763000416546, 00763000439903, 00763000629892, 763000416546; MMT-1882/00763000416553, 00763000439910, 00763000545505, 00763000629908; MMT-1890/763000545604, 763000414344, 763000439859, 763000640095, 00763000414344, 00763000439859, 00763000545604, 76300054560402, 00763000640095, 76300064009502; MMT-1891/00763000642242, 00763000456634, 00763000642235, 00763000418151, 00763000482596; MMT-1892/00763000416553, 00763000439910, 00763000545505, 00763000629908; MMT-1884/00763000414344, 76300081937801, 76300081938501, 763000819378, 763000819385, 00763000586195, A7630007585401, 00763000758547, 00763000439866, 00763000578640, 00763000439859, 00763000545604, 00763000640095, 00763000819392, 763000545604, 00763000758530, 00763000504762; MMT-1885/00763000384258, 00763000521523, 00763000442187, 00763000521509, 00763000578671, 00763000639228, 00763000421939, 00763000597900, 00763000854942, 00763000854829, A7630006392201, 763000384272, 763000521523, 763000854829; MMT-1886/00763000384265, 00763000441449, 00763000521530, 00763000521516, 00763000578688, 00763000442194, 00763000639235, 763000384289, 763000521530, 76300044240801, 763000688165, 76300063923501; MMT-1894/76300086566501, 76300075854701, 763000758547, 763000819392, 763000865665, 00763000758547, 00763000819392; MMT-1895/00763000411411, 00763000734435, 00763000411473, 00763000411466, 00763000541569, 00763000411480, 00763000420703, 00763000411428, 00763000596217, 00763000411404, 00763000533861, 00763000411381, 00763000411503, 00763000596187, 00763000411398, 00763000596194, 00763000411374, 00763000411442, 00763000411435, 00763000411497, 00763000411459, 00763000596224, 00763000411633, 00763000596231, 00763000639266, 00763000384272, 00763000521547, 00763000732585, 763000734435; MMT-1896/763000521554,00763000411510, 00763000411565, 00763000411640, 00763000411541, 00763000411589, 00763000734442, 00763000411527, 00763000411626, 00763000411602, 00763000411558, 00763000523305, 00763000411572, 00763000411596, 00763000914127, 00763000411619, 00763000411534, 00763000734459, 00763000544317, 00763000913250, 00763000533878, 00763000521554, 00763000384289, 00763000639273, 763000734442; All serial numbers.526,558
Based on the official FDA remedy

What to do — step by step

  1. Check Pump Model

    Identify your pump model and reference codes to see if it's listed in the recall.

  2. Monitor Battery Alerts

    Pay close attention to low battery alerts as they may indicate shorter-than-expected battery life.

Where it went and when

Where it was distributed

Distributed in 50 states and D.C. and Puerto Rico, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “US: CT, MI, PA, WA, IA, NY, ND, AZ, TX, OH, NC, AL, MN, IN, NJ, KY, UT, CA, FL, VA, MS, NM, NV, TN, GA, MA, NH, OK, VT, IL, ME, SC, LA, WY, RI, SD, KS, WI, MD, CO, DE, AR, AK, ID, MO, NE, WV, MT, OR, DC, HI, VI, PR. OUS: Worldwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

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

1. Firm started the recall: Jul 31, 202412. FDA classified it Class I: Oct 3, 202423. Published in FDA’s Enforcement Report: Oct 9, 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-0002-2025 (July 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0002-2025 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