Use caution Medical device recall · FDA · Published December 12, 2024
Abiomed Impella RP Flex with SmartAssist: Optical Sensor Damage Risk
Abiomed recalls Impella RP Flex with SmartAssist pumps with serial numbers listed. Optical sensors may be damaged during insertion or manipulation of guidewires or central venous lines, causing temporary or permanent pump stop. Check your pump's serial number against the list.
Use caution until it’s fixed
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Contact the company
Recalling firmAbiomed, Inc.24 Cherry Hill Dr · Danvers, MA 01923-2575
What happened, in plain English
Abiomed is recalling certain Impella RP Flex with SmartAssist pumps due to a risk of optical sensor damage when guidewires or central venous lines interact with the pump's inlet during insertion, manipulation, or removal. This can cause temporary or permanent pump stoppage, potentially disrupting critical heart support. Read more at govinfonow.com/recall/53305-abiomed-impella-rp-flex-with-smartassist-optical-sensor-damage-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/53305-abiomed-impella-rp-flex-with-smartassist-optical-sensor-damage-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0830-2025
Cite this page
“Abiomed Impella RP Flex with SmartAssist: Optical Sensor Damage Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/53305-abiomed-impella-rp-flex-with-smartassist-optical-sensor-damage-risk. Based on FDA recall #Z-0830-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0830-2025%22&limit=1).
Why it’s dangerous
The optical sensors in these pumps can be damaged when guidewires, central venous lines, or other devices interact with the pump's inlet during insertion, manipulation, or removal. This may cause temporary pump stoppage or permanent damage, disrupting critical heart support.
Who’s affected
Healthcare professionals using the Impella RP Flex with SmartAssist pumps with specific serial numbers listed in the recall. Patients receiving this device are at risk if their pumps are affected.
How to tell if you have this one
Check your Impella RP Flex with SmartAssist pump's serial number against the list of affected numbers provided in the recall. The affected pumps have serial numbers starting with 537606 through 549647 and other specific numbers listed.
- Brand
Abiomed- Category
Medical device
All 2 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
Domestic: Nationwide Distribution International: Canada
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0829-2025 | Impella RP with SmartAssist; Product Number: 0046-0035;; Product Number: 0046-0035; UDI-DI: 00813502011869; Serial Numbers: 492884, 492882, 492883, 522056, 522054, 522055, 522106, 522107, 522110, 522111, 522105, 522109, 520014, 520017, 520018, 520019, 520020, 520021, 520022, 520023, 520747, 520748, 520743, 520744, 520746, 520739, 520740, 520664, 520742, 520660, 520661, 520663, 520666, 520668, 518497, 520659, 520665, 518500, 518501, 518496, 518494, 518499, 518502, 518503, 518963, 518960, 518961, 518962, 518959, 518958, 518955, 518956, 507392, 518954, 507386, 507389, 507390, 507391, 507385, 507384, 507393, 492683, 492682, 492681, 492680, 489923, 489921, 489919, 489918, 489916, 489917, 489915, 492677, 492679, 492674, 509155, 509156, 509157, 509151, 509154, 509149, 491454, 509148, 509150, 491456, 491457, 491458, 491455, 491460, 491461, 491462, 491463, 486724, 486717, 486718, 486721, 476036, 476038, 476034, 476035, 476033, 476032, 476031, 489894, 489892, 489893, 489889, 491433, 491437, 489886, 489887, 489888, 491431, 491432, 491436, 484301, 491435, 484300, 483987, 483986, 483984, 483985, 483979, 483981, 483988, 484302, 484294, 484295, 484296, 484298, 486727, 486725, 486726, 486729, 486728, 486732, 486733, 486734, 469495, 469494, 469492, 469493, 469497, 469496, 469488, 469489, 469490, 469491, 476257, 484772, 472427, 472429, 476254, 484773, 484774, 484775, 472430, 476253, 476255, 476250, 476256, 484769, 484771, 467632, 472081, 476259, 472073, 472074, 476251, 476258, 484767, 472075, 472077, 472076, 472078, 472079, 472432, 484776, 471719, 471724, 476303, 471722, 476307, 471717, 471725, 476304, 476306, 470544A, 475366, 475367, 474979, 475361, 475362, 481841, 479952, 474975, 474977, 474978, 474980, 474972, 476301, 479950, 462945, 479947, 481839, 462942, 462944, 476300, 479948, 481843, 474973, 474974, 481844, 481845, 475363, 462946, 481838, 481840, 479944, 475305, 479949, 472352, 475309, 479945, 479946, 475302, 475306, 475303, 478251, 478252, 478253, 478255, 478258, 475308, 475310, 478260, 475307, 475311, 472350, 472355, 472348, 472351, 472354, 472347, 472349, 472356, 473130, 473126, 473127, 472145, 472146, 473128, 472150, 472152, 464043, 465462, 472353, 465592, 470129, 470135, 473125, 473132, 466807A, 469668, 468237, 469850, 472148, 472149, 472151, 469851, 469857, 472143, 472144, 473129, 473133, 473134, 470546, 470579, 470585, 470542, 470545, 470578, 470580, 472437, 472438, 473122, 470581, 472439, 472441, 473124, 472442, 472445, 473117, 473119, 473116, 473118, 473120, 469520, 473106, 473121, 469518, 470459, 470461, 473107, 470458, 470457, 470547, 473112, 473115, 470540, 470541, 470553, 473110, 473111, 473113, 470548, 470549, 470552, 473109, 472440, 472443, 469519, 470537, 473108, 469515, 470538, 470539, 469513, 469514, 469516, 469517, 469521, 470555, 470377, 470376, 470374, 470372, 460028, 460026, 460022, 460023, 460021, 460025, 470530, 470536, 470531, 470534, 470528, 470529, 470378, 470380, 470381, 460024, 460020, 469854, 469673, 469848, 469849, 469853, 470130, 470131, 459388A, 470132, 470133, 470128, 470137, 469856, 469852, 469556, 469956, 469957, 468233, 469953, 469955, 468231, 468234, 468235, 468239, 468238, 469557, 469949, 469952, 469671, 469950, 469550, 469670, 464554, 464600, 469548, 469549, 469551, 469552, 469554, 469555, 464553, 469669, 469672, 469553, 464048, 464042, 464044, 464045, 464049, 464601, 464602, 464607, 464603, 464606, 464556, 462956, 459565, 462778, 462779, 454319, 454322, 461876, 461877, 461881, 464548, 464549, 464550, 464551, 464552, 464557, 462955, 462957, 462771, 462774, 462775, 462776, 462777, 462950, 462951, 464555, 462770, 462772, 454323, 454326, 465599, 465600, 465598, 465601, 465593, 465594, 465595, 465596, 465597, 463653, 464207, 463655, 464202, 464208, 463654, 464203, 464204, 464205, 464206, 463656, 463657, 463658, 463660, 463662, 463633, 463634, 468019, 463635, 463640, 463641, 468016, 468017, 468018, 468023, 468020, 468022, 463185, 463188, 463189, 463187, 464034, 464035, 464036, 464037, 464038, 463191, 463193, 464031, 464032, 464039, 464040, 463192, 463190, 469667, 466014, 466015, 466016, 468480, 468481, 465459, 465464, 468479, 465456, 465457, 465460, 465461, 465463, 465465, 468484, 468485, 468487, 468488, 468482, 468483, 469660, 469663, 469664, 466007, 466008, 469665, 469666, 466009, 466010, 466011, 465546, 465544, 465547, 465548, 465545, 454679, 461872, 466808, 466812, 466813, 466809, 466811, 466814, 466815, 461774, 466774, 464213, 464214, 464218, 465541, 465542, 465543, 466773, 464216, 464217, 464219, 464220, 461866, 462937, 461864, 462935, 462936, 461865, 461869, 461871, 462939, 466771, 461766, 461768, 462930, 462933, 462938, 466769, 466770, 461771, 461772, 461773, 461778, 461775, 461776, 461777, 461780, 466767, 466768, 461779, 461782, 461758, 461728, 461755, 461757, 461759, 461730, 461754, 461763, 461756, 460044, 460045, 460046, 460049, 460366, 460377, 460042, 460048, 460375, 460367, 460365, 460368, 461727, 461731, 461732, 460378, 460382, 460383, 461729, 460372, 460373, 461119, 461120, 461121, 461124, 461733, 461122, 461123, 461126, 461127, 460030, 460032, 460034, 459666, 460031, 460036, 460037, 460038, 459668, 460040, 459667, 459671, 459672, 459674, 444540A, 459730, 459572, 459573, 459725, 459726, 459727, 459728, 459729, 459566, 459662, 459663, 459664, 459567, 459568, 459570, 459655, 459660, 459661, 459731, 459732, 459733, 459734, 459657, 459658, 459659, 459571, 459363, 459364, 459365, 459366, 459367, 459370, 459381, 459385, 459386, 459382, 459387, 459368, 459369, 459383, 459384, 459389, 459390, 459195, 459193, 459194, 459196, 459190, 459191, 459208, 457733, 459189, 459192, 459207, 457511, 457734, 457509, 457512, 459205, 459206, 457728, 457729, 457731, 457732, 459202, 459203, 459204, 457508, 457513, 457515, 457727, 459361, 459362, 457503, 457505, 457498, 457499, 457506, 457496, 457497, 457500, 456135, 456134, 456136, 456137, 456139, 456140, 456141, 456206, 456132, 456202, 456203, 456207, 456092, 456095, 456097, 456210, 456211, 456801, 456093, 456094, 456208, 456803, 457396, 457400, 457403, 456069, 456098, 456099, 456100, 456800, 457405, 457404, 455614, 455615, 455616, 455618, 456062, 456063, 456065, 456067, 456068, 456064, 455609, 455610, 442270A, 454308, 455574, 455575, 454307, 443794, 454306, 455570, 455571, 455573, 455577, 454299, 454302, 454673, 455569, 454303, 454304, 454674, 454678, 454680, 454681, 454677, 454682, 451712, 451713, 451715, 451716, 453978, 453982, 453983, 451711, 453976, 453977, 454015, 454019, 454021, 454023, 455325, 455328, 455321, 451717, 455320, 455324, 451665, 451667, 451668, 451669, 451671, 448756, 448762, 451666, 452467, 452470, 452472, 452473, 448753, 448754, 448755, 451673, 448661, 451218, 451219, 452558, 452560, 452561, 451212, 451215, 452476, 448656, 448657, 448658, 448660, 448663, 451210, 448654, 450016, 450017, 450363, 450364, 450355, 450357, 450358, 450360, 450361, 450362, 442215, 442217, 442218, 427706A, 446244, 446245, 446246, 446249, 446549, 446242, 446243, 446540, 446545, 446547, 446548, 446240, 446248, 446542, 446241, 446247, 446920, 446921, 446925, 446926, 446927, 446928, 449911, 449915, 449912, 449909, 449913, 449914, 449918, 446395, 446397, 446398, 446404, 445897, 445898, 445906, 445899, 445900, 445905, 445901, 445902, 445903, 445904, 444833, 444831, 444830, 444775, 444777, 445888, 445890, 445893, 445894, 444769, 444796, 444798, 444793, 444795, 444791, 443496, 442498, 442730, 442731, 443497, 443498, 443499, 443502, 440916, 442493, 442494, 443504, 443505, 443796, 444539, 444543, 442500, 442724, 444541, 444544, 444546, 444548, 442725, 442727, 443590, 443631, 443586, 443592, 443594, 443595, 443627, 443628, 443630, 443633, 443635, 444529, 443800, 444530, 444532, 444533, 444534, 443792, 443795, 443797, 443798, 443799, 444535, 444536, 444531, 444537, 444538, 442276, 442274, 442275, 442281, 442279, 442263, 442273, 442267, 442268, 442271, 440909, 440912, 440914, 440907, 440911, 436350, 437774, 440329, 440330, 440331, 440333, 440334, 436342, 436345, 437775, 437776, 437777, 437779, 437780, 436344, 436347, 436348, 434310, 434308, 434309, 427420, 434212, 434219, 434311, 434312, 434313, 434213, 434214, 434215, 434216, 434217, 434218, 434306, 434307, 434211, 434284, 434286, 434287, 434288, 434289, 434290, 434291, 434292, 434293, 427418, 428696, 432885, 432886, 432891, 432888, 432890, 427411, 427412, 428698, 432887, 432892, 427365, 427409, 427410, 428699, 428702, 427360, 427364, 427366, 428693, 428695, 428357, 428359, 428362, 428364, 428355, 428356, 431686, 431687, 431688, 431689, 431690, 431691, 428935, 428936, 428938, 431692, 428939, 428940, 431107, 431110, 431114, 431113, 431115, 431684, 432880, 432881, 432882, 426557, 431685, 432875, 432876, 432877, 432878, 427423, 427425, 427426, 427428, 427709, 427708, 427710, 427419, 427421, 427422, 427427, 427707, 428928, 428931, 428934, 428926, 428933, 427711, 427712, 427713, 428925, 428333, 428334, 428335, 428338, 428341, 428342, 428336, 428337, 416217A, 426564, 426562, 426565, 426558, 426560, 426563, 426556, 422560, 427107, 427106, 427111, 422557, 422544, 422729, 422736, 422548, 427102, 422552, 422728, 422558, 422559, 427109, 427110, 422545, 422547, 422550, 422551, 422734, 422735, 422546, 422549, 422727, 422730, 425774, 425259, 424879, 424881, 424883, 424884, 425258, 425780, 424548, 424885, 425254, 425257, 424546, 424547, 424887, 424888, 425261, 425850, 425854, 425260, 425771, 425779, 425852, 425855, 425857, 425858, 425853, 423325, 423608, 423609, 423865, 424539, 424545, 410463, 423601, 423602, 423866, 421655, 423606, 423870, 423872, 423874, 424540, 423607, 423868, 423871, 423321, 423322, 423326, 423329, 423330, 423867, 423869, 424541, 424542, 424543, 424544, 421657, 421658, 421659, 421660, 421661, 413759A, 417581, 417582, 417583, 417584, 417586, 417588, 417579, 422155, 422156, 422157, 422554, 422154, 422158, 422159, 422160, 422553, 422152, 422556, 422561, 419372, 421652, 421653, 421654, 422142, 422145, 422146, 419368, 419370, 419377, 419373, 419374, 422147, 422149, 422150, 422148, 422143, 422144, 421168, 418886, 421163, 421165, 421169, 420317, 421160, 421167, 418887, 418888, 418889, 420318, 420319, 421161, 421162, 420313, 420314, 419990, 420311, 420312, 420315, 419989, 419983, 419985, 419986, 420310, 420316, 415264, 415266, 417877, 417878, 415257, 415259, 415261, 415262, 415263, 415260, 418446, 418448, 418883, 416214, 416221, 417882, 417884, 417885, 417886, 418884, 418885, 416215, 416216, 416218, 416220, 416223, 418440, 418441, 418444, 418445, 414298, 414299, 413709, 414296, 414301, 414303, 414985, 414987, 414983, 414984, 414992, 414304, 414305, 414988, 414989, 414990, 406483, 406484, 397113, 413701, 413702, 413703, 413704, 413705, 413706, 412898, 412899, 412901, 412894, 412902, 412903, 413707, 412895, 412896, 412897, 399628, 418124, 418125, 418126, 418127, 418128, 418129, 418131, 418132, 403394, 418133, 415228, 415229, 415234, 415235, 410458A, 412261, 413754, 413756, 413757, 413758, 415227, 413755, 415231, 415232, 415233, 415236, 409387, 412266, 412505, 412509, 412511, 413750, 413752, 413753, 413683, 413685, 410454, 413688, 412259, 412263, 410455, 410456, 411139, 412264, 412503, 412504, 412506, 413686, 413687, 413689, 413680, 413681, 413682, 411142, 411144, 411147, 410457, 410459, 411141, 411143, 410461, 410462, 411140, 409935A, 401564, 411138, 401563, 401566, 410094, 410095, 410096, 410099, 410100, 410102, 411092, 410103, 411093, 411094, 411095, 411096, 401759, 411088, 411089, 411090, 401757, 401758, 411091, 401753, 401754, 401760, 401761, 411097, 401755, 401756, 409940, 409395, 401559, 401560, 401561, 409248, 409389, 409390, 409391, 409394, 409936, 409937, 409941, 409938, 408876, 408878, 409393, 409939, 409944, 402230, 408873, 408874, 409245, 409388, 409392, 408871, 408875, 408879, 409942, 409943, 402225, 402227, 408353, 402229, 408354, 409243, 409247, 409249, 409250, 408576, 409105, 402476, 402483, 409102, 409103, 409104, 409106, 409108, 402475, 402481, 408577, 408580, 408583, 408584, 408585, 409107, 402474, 402479, 402480, 402482, 407024, 408158, 408161, 407019, 407021, 407023, 407025, 408156, 408157, 405865, 405866, 405868, 405869, 405870, 407018, 408164, 405863, 405871, 405872, 408162, 408163, 408165, 408357, 408358, 402224, 402231, 402232, 406491, 408356, 408359, 405060, 405061, 405062, 406489, 406486, 406487, 406490, 406483, 406484, 406482, 403467, 405059, 405055, 405056, 405058, 403464, 403465, 403468, 405054, 403073, 403074, 403075, 403079, 403080, 394644, 394645, 394640, 394641, 394643, 401999, 402000, 403461, 403463, 402002, 402004, 402005, 402007, 403071, 403401, 403460, 403394, 403398, 403399, 403400, 403402, 394646, 394649, 403393, 403397, 401079, 401083, | 1,560 units |
| Z-0830-2025 | Impella RP Flex with SmartAssist; Product Number: 1000323;; Product Number: 1000323; UDI-DI: 00813502012811; Serial Numbers: 551121, 551122, 551123, 551124, 551125, 551127, 551128, 551129, 537606, 537610, 537612, 537615, 537607, 537608, 537609, 537613, 537614, 548547, 548548, 548550, 548553, 548554, 548555, 548556, 548552, 548559, 548560, 548561, 548562, 548563, 548564, 548565, 549638, 549640, 549641, 549642, 549643, 548558, 546672, 546675, 546676, 546678, 546679, 546680, 547552, 547556, 547558, 547559, 547560, 546652, 546654, 546656, 546657, 546658, 546659, 547561, 549644, 549646, 549647, 546661, 547563, 547564, 547566, 547567, 547568, 547569, 547570, 547571, 546681, 547189, 547191, 547192, 547193, 547194, 547195, 548827, 548830, 548831, 548834, 548835, 548836, 543714, 543716, 543719, 543720, 543721, 543722, 547169, 547170, 547171, 547172, 547173, 547174, 547188, 548188, 548189, 548196, 545799, 545800, 545801, 545802, 545803, 545804, 548191, 548192, 548193, 548194, 545486, 545488, 545795, 545796, 545797, 529171, 529172, 529174, 529175, 529179, 545475, 545478, 545481, 545482, 545483, 545489, 545490, 545491, 545492, 545494, 539350, 539352, 539353, 539354, 539355, 543274, 543275, 543276, 543277, 543278, 543279, 543282, 529170, 543273, 543283, 543284, 543286, 544125, 544126, 544130, 539356, 539357, 539358, 539359, 539794, 539795, 539797, 539799, 544123, 544124, 544127, 538387, 538388, 538389, 539790, 539791, 539792, 539793, 538381, 538382, 538383, 538384, 538385, 538386, 543285, 543288, 543289, 543292, 535401, 535403, 535404, 535405, 535407, 539820, 539822, 539823, 539824, 539825, 539826, 539829, 535408, 535409, 535410, 537995, 539800, 539801, 539803, 539806, 539809, 528198, 528199, 535421, 535425, 535427, 535428, 537993, 539805, 537992, 539807, 539808, 531407, 531410, 531411, 531413, 537996, 537997, 537999, 528191, 528192, 528193, 528194, 528195, 531414, 531415, 533140, 533141, 533142, 536414, 536415, 536416, 536417, 536418, 536419, 532106, 533074, 533075, 533079, 533134, 533135, 533137, 533138, 533139, 537973, 537974, 537976, 537980, 538376, 544138, 544139, 544140, 538371, 538372, 538375, 538377, 538378, 538380, 539340, 539341, 539344, 539345, 539347, 539348, 536531, 536534, 536535, 536536, 536537, 539784, 533081, 533082, 533083, 539785, 539786, 539788, 539789, 544131, 544132, 544133, 544134, 544135, 544940, 544941, 544942, 544944, 544945, 544947, 544950, 544952, 544954, 544955, 544957, 544958, 518335, 518337, 518338, 518339, 518340, 518341, 518342, 518343, 544948, 544949, 537661, 537663, 537664, 516715A, 518326A, 518328A, 518329A, 518330A, 518332A, 518333A, 516709A, 516712A, 518476A, 518477A, 518479A, 518480A, 518481A, 518482A, 516706A, 516707A, 516708A, 516767A, 516768A, 516769A, 516770A, 516771A, 516773A, 516774A, 518474A, 518475A, 536560, 536563, 536566, 536568, 536711, 537665, 537666, 537667, 537668, 537669, 535272, 535273, 536712, 536713, 536714, 536715, 536717, 536718, 533798, 533800, 533801, 533804, 533805, 535274, 535275, 535276, 535277, 535278, 535279, 531698, 531702, 531703, 531704, 531705, 531706, 533806, 533807, 531707, 535155, 535156, 535157, 535158, 535160, 535162, 535164, 536719, 531425, 531426, 531417, 531418, 531419, 531420, 531421, 535793, 535794, 535796, 535797, 535800, 535761, 535763, 535765, 535767, 535770, 535791, 535792, 535768, 535769, 524385, 526612, 526614, 526615, 526617, 526618, 528640, 528641, 528643, 526611, 529503, 530051, 530052, 530054, 530055, 530056, 530057, 530059, 526609, 526610, 527878, 527879, 527875, 527876, 527877, 529915, 529916, 529919, 529920, 529921, 529922, 529923, 531728, 531730, 531731, 531732, 531733, 531734, 531735, 531736, 533405, 533406, 533407, 533408, 533409, 533410, 533412, 533413, 530680, 530681, 530682, 530684, 530685, 530687, 530688, 530689, 526179, 526185, 533044, 533045, 533046, 533047, 533049, 533520, 533522, 533523, 533524, 533529, 526180, 526181, 526182, 526184, 526186, 526187, 527870, 527871, 527872, 532099, 532100, 532101, 532102, 536392, 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511458, 511459, 511460, 511463, 510914, 510915, 510916, 510899, 510900, 510902, 510903, 510905, 510907, 510908, 510909, 510911, 510912, 510913, 511446, 511447, 509348, 509349, 509350, 509351, 509354, 509356, 509357, 509355, 509921, 509922, 509923, 509930, 509924, 509929, 507810, 506536, 507804, 507805, 507806, 507807, 507808, 504771, 504772, 504773, 504775, 504776, 504777, 506529, 506531, 506532, 506535, 504769, 504770, 504018, 504019, 504020, 504021, 507334, 507335, 504015, 504016, 504022, 507330, 507332, 507337, 507811, 504023, 506537, 507338, 507812, 506538, 507329, 510571, 510573, 510574, 510575, 510580, 507604, 507606, 507609, 507611, 507613, 510546, 510547, 510550, 510552, 510554, 510577, 508406, 508409, 508411, 508412, 508413, 500468, 506824, 506825, 506832, 507143, 507144, 510141, 510142, 510143, 510145, 510146, 510147, 510155, 510170, 506827, 506831, 510150, 500470, 500469, 500472, 500475, 507146, 507147, 507148, 500467, 500471, 500473, 500474, 507145, 501658, 501659, 501661, 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495141, 495143, 495142, 494375, 494369, 494370, 494372, 494373, 494374, 494377, 494378, 495140, 495159, 493530, 493532, 493533, 493534, 493975, 493529, 493970, 493527, 493528, 493531, 493535, 493526, 493974, 493979, 488964, 492487, 492492, 494335, 492485, 493191, 494338, 493186, 492484, 493187, 493193, 494337, 492493, 492488, 492490, 492491, 494334, 494341, 492486, 492489, 493188, 493189, 493192, 493194, 492206, 492207, 492208, 492209, 492211, 490454, 490456, 490457, 490459, 490460, 490461, 490462, 492205, 442295A, 490455, 490458, 484758, 484763, 484765, 484766, 492252, 492627, 492629, 492253, 492633, 492246, 484761, 492244, 492245, 492248, 492625, 492626, 492630, 492631, 492251, 490250, 490247, 490243, 490244, 490246, 490248, 490249, 490245, 490251, 489554, 490446, 488989, 488992, 488993, 489545, 489546, 489547, 489548, 489549, 489551, 490254, 490255, 490256, 490257, 490258, 490259, 490447, 490448, 490452, 488987, 488988, 488991, 489553, 490260, 490449, 490450, 490262, 490444, 490445, 488968, 490434, 490437, 490438, 490441, 490442, 490439, 488966, 488967, 486478, 488608, 488732, 488965, 486475, 486477, 488607, 488609, 488733, 488734, 488962, 486476, 488725, 488729, 486470, 486471, 486473, 488600, 488601, 488602, 488726, 488727, 488728, 488730, 488731, 488960, 488604, 488605, 488606, 488603, 485106, 485108, 483967, 485107, 485111, 484291, 484292, 485110, 483968, 485109, 485387, 485388, 483961, 483964, 483965, 483966, 485102, 485103, 485105, 485382, 485383, 485390, 485391, 483959, 483960, 485104, 484290, 485386, 484284, 484285, 484288, 484289, 484293, 485384, 482360, 482361, 488583, 488587, 483299, 483300, 483301, 483305, 488585, 482356, 483302, 483312, 483313, 483315, 483963, 488581, 483307, 483317, 482352, 482358, 482359, 483298, 483308, 483309, 483310, 483316, 488584, 482354, 482355, 482357, 486114, 486120, 485692, 485694, 485695, 486109, 486112, 486115, 486117, 486121, 486125, 486129, 486130, 486131, 486135, 486136, 485697, 485699, 486118, 486122, 486124, 486128, 486132, 486133, 485693, 485700, 485701, 486107, 488586, 488589, 482203, 482346, 482350, 482351, 482198, 482206, 482338, 482348, 482204, 482205, 482197, 482199, 482334, 482344, 482202, 482333, 482337, 482332, 482335, 482339, 482341, 482345, 482347, 482142, 482145, 482147, 482193, 444471, 484756, 482146, 482148, 482225, 484747, 444470, 482190, 482191, 482217, 482223, 482224, 484751, 484754, 444477, 444469, 482150, 482192, 482218, 482220, 482189, 482219, 444472, 482149, 484749, 444473, 444474, 444475, 444476, 444478, 482187, 482221, 484750, 484752, 484753, 444241, 443183, 443184, 443188, 444246, 444247, 444788, 443185, 443187, 443191, 443492, 444243, 444248, 444784, 443192, 443487, 443488, 444244, 444245, 444816, 454662, 444810, 454653, 454654, 454661, 444811, 454604, 454648, 454649, 454650, 454657, 454659, 444818, 454643, 444815, 454655, 452533, 452539, 452457, 452458, 452459, 452461, 452462, 452463, 452464, 452465, 452530, 452536, 449676, 449679, 453939, 453940, 442458, 442459, 449675, 449682, 451977, 453933, 449890, 442453, 449895, 449898, 442202, 442203, 442204, 442455, 449896, 452037, 452039, 452041, 452042, 442206, 442207, 452035, 442209, 442210, 442211, 442457, 452034, 452036, 441272, 441273, 440011, 440167, 440168, 440169, 440171, 440172, 440173, 440174, 441276, 441279, 441281, 441275, 439837, 439840, 440927, 440929, 440931, 440935, 442258, 440932, 441322, 441324, 441326, 441327, 442292, 442293, 441323, 442294, 442298, 442299, 442300, 442301, 442421, 442257, 442416, 442417, 442419, 442420, 442422, 442413, 442414, 442418, 439833, 439839, 440005, 439835, 440003, 440006, 439538, 439541, 439543, 439495, 439497, 439498, 439499, 439500, 439535, 439537, 440984, 440985, 439536, 438640, 438642, 438646, 438837, 438838, 438841, 440191, 438835, 438840, 439006, 439007, 439008, 439009, 436502, 439004, 439005, 438644, 438648, 438843, 439002, 440189, 438647, 440187, 436875A, 438842, 439000, 439001, 438607, 438606, 437526, 438608, 437531, 438777, 438773, 437528, 437530, 437799, 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416645, 416646, 416653, 416644, 416650, 409542, 416647, 416649, 416651, 411373, 411374, 411376, 411377, 411372, 411378, 411379, 411380, 410413, 410411, 410412, 410408, 410409, 410405, 410410, 410406, 410407, 407255A, 407988A, 407991A, 407989A, 407994A, 407253A, 407992A; | 2,364 units |
What to do — step by step
Check Pump Serial Number
Compare your pump's serial number with the list of affected serial numbers provided in the recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Domestic: Nationwide Distribution International: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- 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-0830-2025 (December 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0830-2025 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.