FDA · Class II · September 23, 2026

Maquet Cardiopulmonary recall: Percutaneous Insertion Kit

Maquet Cardiopulmonary Gmbh is recalling Percutaneous Insertion Kit – 68371 units (1765 US, 66606 OUS); 185617 units (5926 US, 179691 OUS); 16697 units (492 USA, 16205 OUS). The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on July 31, 2026. Distributed nationwide.

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.

Product	Percutaneous Insertion Kit
Brand	Maquet Cardiopulmonary
Company	Maquet Cardiopulmonary Gmbh
Type	Medical devices
Classification	Class II
Recall date	July 31, 2026
Published by FDA	September 23, 2026
Quantity	68371 units (1765 US, 66606 OUS); 185617 units (5926 US, 179691 OUS); 16697 units (492 USA, 16205 OUS)
Recall ID	99668

As listed by FDA

Recalled products (3)

Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
FDA recall number
Z-3144-2026
Codes, lots and dates
Model Number (USA): 701053068; UDI-DI: 4037691519883; Lot Numbers: 3000324477, 3000333824, 3000336037, 3000341450, 3000343893, 3000377475, 3000387891, 3000403656, 3000414516, 3000430803, 3000441821, 3000453326, 3000471523, 3000476321, 3000485151, 3000496204, 3000510428, 3000518006, 3000554731; Model Number (OUS): 701047384; UDI-DI: 4037691730660; Lot Numbers: 3000324479, 3000324480, 3000328829, 3000328830, 3000328831, 3000331203, 3000331204, 3000331206, 3000331224, 3000333819, 3000333820, 3000334780, 3000334781, 3000334782, 3000336034, 3000336035, 3000338097, 3000338098, 3000339838, 3000339839, 3000341457, 3000341458, 3000342412, 3000342413, 3000343902, 3000343903, 3000347872, 3000347873, 3000349433, 3000350472, 3000350473, 3000350474, 3000351949, 3000351950, 3000353375, 3000354955, 3000354956, 3000354957, 3000356333, 3000356334, 3000356335, 3000357761, 3000357762, 3000359475, 3000364061, 3000364062, 3000369310, 3000369312, 3000369316, 3000372382, 3000372383, 3000373778, 3000373779, 3000374100, 3000375677, 3000375678, 3000375679, 3000378518, 3000378519, 3000379856, 3000382445, 3000384006, 3000385167, 3000385168, 3000387892, 3000387893, 3000390768, 3000392520, 3000393467, 3000393468, 3000397030, 3000398789, 3000400250, 3000404891, 3000404892, 3000408177, 3000408178, 3000408179, 3000410260, 3000413601, 3000413602, 3000414518, 3000414519, 3000417088, 3000418477, 3000418478, 3000420374, 3000420375, 3000423667, 3000423674, 3000425774, 3000431820, 3000431821, 3000434595, 3000434596, 3000434597, 3000434598, 3000438009, 3000438010, 3000441823, 3000444273, 3000444274, 3000445644, 3000445976, 3000445977, 3000448171, 3000448172, 3000449726, 3000451983, 3000453329, 3000453330, 3000455122, 3000455123, 3000461218, 3000461219, 3000466034, 3000466035, 3000468419, 3000468420, 3000468421, 3000471524, 3000471525, 3000471526, 3000471527, 3000475598, 3000477178, 3000477182, 3000478745, 3000478834, 3000479561, 3000479563, 3000481002, 3000481003, 3000481944, 3000485139, 3000485141, 3000486782, 3000486787, 3000488306, 3000488307, 3000489894, 3000491429, 3000493064, 3000496195, 3000498672, 3000501301, 3000501302, 3000502838, 3000502839, 3000503938, 3000504934, 3000504935, 3000506575, 3000506576, 3000507640, 3000507642, 3000508153, 3000522416, 3000522469, 3000523507, 3000523508, 3000525035, 3000525036, 3000525037, 3000525038, 3000525457, 3000525458, 3000525459, 3000526917, 3000526918, 3000528230, 3000528713, 3000530040, 3000533974, 3000534003, 3000535434, 3000537044, 3000539529, 3000539530, 3000539531, 3000543967, 3000547000, 3000549187, 3000549188, 3000550935, 3000553328, 3000553329, 3000554725, 3000554726;
Quantity
68371 units (1765 US, 66606 OUS)
Classification
Class II
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
FDA recall number
Z-3145-2026
Codes, lots and dates
Model Number (USA): 701053069; UDI-DI: 4037691730677; Lot Numbers: 3000324478, 3000326922, 3000336965, 3000339840, 3000347863, 3000370471, 3000374104, 3000379854, 3000382443, 3000395582, 3000403657, 3000414517, 3000430804, 3000434603, 3000444269, 3000445982, 3000453327, 3000466026, 3000471522, 3000476322, 3000476324, 3000479560, 3000485154, 3000491022, 3000496205, 3000503935, 3000510431, 3000511851, 3000518007, 3000520749, 3000525464, 3000528231, 3000534008; Model Number (OUS): 701047385; UDI-DI: 4037691519876; Lot Numbers: 3000324481, 3000324482, 3000324483, 3000326924, 3000326926, 3000326927, 3000326928, 3000328824, 3000328825, 3000328826, 3000328827, 3000328828, 3000331194, 3000331195, 3000331196, 3000331197, 3000331198, 3000331199, 3000331225, 3000333814, 3000333815, 3000333816, 3000333817, 3000333818, 3000334775, 3000334776, 3000334777, 3000334778, 3000334779, 3000336028, 3000336029, 3000336030, 3000336031, 3000336032, 3000336033, 3000338092, 3000338093, 3000338094, 3000338095, 3000338096, 3000339833, 3000339834, 3000339835, 3000339836, 3000339837, 3000341453, 3000341454, 3000341455, 3000341456, 3000342415, 3000342416, 3000342417, 3000342418, 3000342419, 3000342420, 3000342421, 3000342422, 3000343894, 3000343895, 3000343896, 3000343897, 3000343898, 3000343899, 3000343900, 3000343901, 3000345720, 3000345721, 3000345722, 3000345723, 3000345724, 3000345725, 3000345726, 3000345727, 3000345728, 3000345729, 3000347867, 3000347868, 3000347869, 3000347870, 3000349429, 3000349430, 3000349431, 3000349432, 3000349434, 3000350476, 3000350477, 3000350478, 3000350479, 3000351515, 3000351516, 3000351517, 3000351518, 3000351951, 3000351952, 3000351953, 3000351954, 3000353376, 3000353377, 3000353378, 3000353379, 3000353380, 3000354958, 3000354959, 3000354960, 3000356336, 3000356337, 3000356338, 3000356339, 3000357758, 3000357759, 3000357760, 3000359472, 3000359473, 3000359474, 3000359476, 3000363549, 3000363550, 3000369079, 3000369080, 3000369265, 3000369266, 3000369317, 3000369318, 3000369320, 3000370467, 3000370468, 3000370469, 3000370470, 3000372386, 3000372387, 3000372388, 3000372389, 3000373780, 3000373781, 3000373782, 3000373783, 3000374102, 3000374103, 3000375675, 3000375676, 3000377476, 3000377477, 3000377478, 3000378520, 3000378521, 3000378522, 3000378523, 3000379857, 3000379858, 3000379859, 3000382446, 3000382447, 3000382448, 3000382449, 3000384008, 3000384009, 3000384012, 3000384013, 3000384018, 3000385169, 3000385171, 3000385172, 3000385173, 3000387896, 3000387897, 3000387898, 3000387899, 3000389001, 3000389002, 3000389003, 3000389004, 3000389005, 3000390764, 3000390765, 3000390766, 3000390767, 3000392517, 3000392518, 3000392519, 3000392521, 3000392523, 3000393469, 3000393471, 3000393472, 3000395577, 3000395578, 3000395579, 3000395580, 3000397025, 3000397027, 3000397028, 3000397029, 3000397033, 3000397034, 3000398275, 3000398786, 3000398787, 3000398788, 3000400244, 3000400245, 3000400246, 3000400247, 3000400248, 3000400249, 3000404886, 3000404887, 3000404888, 3000404889, 3000404890, 3000406842, 3000406846, 3000406847, 3000406849, 3000408180, 3000408181, 3000408182, 3000408183, 3000408184, 3000408185, 3000410261, 3000410262, 3000410263, 3000410264, 3000411200, 3000412146, 3000412642, 3000412643, 3000413597, 3000413598, 3000413599, 3000413600, 3000414520, 3000414521, 3000414522, 3000414523, 3000414524, 3000417082, 3000417083, 3000417084, 3000417085, 3000417086, 3000417087, 3000418479, 3000418480, 3000418481, 3000418482, 3000420376, 3000420377, 3000420378, 3000423668, 3000423669, 3000423671, 3000423672, 3000423673, 3000424270, 3000424271, 3000424272, 3000424273, 3000424274, 3000425770, 3000425771, 3000425772, 3000425773, 3000431822, 3000431823, 3000431824, 3000431825, 3000431826, 3000431827, 3000431828, 3000434599, 3000434600, 3000434601, 3000434602, 3000438012, 3000438013, 3000441388, 3000441389, 3000441824, 3000444275, 3000444276, 3000444277, 3000444718, 3000444719, 3000444720, 3000444721, 3000445645, 3000445646, 3000445647, 3000445648, 3000445978, 3000445979, 3000445980, 3000445981, 3000448173, 3000448174, 3000448175, 3000448176, 3000448177, 3000449727, 3000449728, 3000449729, 3000449730, 3000451984, 3000451985, 3000451986, 3000451987, 3000451988, 3000453331, 3000453332, 3000455124, 3000455125, 3000455126, 3000455127, 3000458528, 3000458529, 3000458530, 3000458531, 3000458532, 3000461212, 3000461213, 3000461214, 3000461215, 3000461217, 3000464623, 3000464624, 3000464625, 3000464626, 3000466030, 3000466031, 3000466032, 3000466033, 3000468423, 3000468424, 3000468425, 3000471528, 3000471529, 3000471530, 3000471531, 3000471536, 3000471541, 3000471542, 3000471544, 3000475595, 3000475596, 3000475597, 3000477179, 3000477180, 3000477181, 3000478746, 3000478747, 3000478748, 3000478749, 3000478836, 3000479564, 3000479565, 3000479567, 3000481004, 3000481005, 3000481006, 3000481945, 3000481946, 3000481947, 3000481948, 3000484178, 3000484179, 3000484180, 3000484181, 3000485143, 3000486784, 3000486785, 3000486786, 3000488308, 3000488309, 3000488310, 3000489895, 3000489896, 3000490871, 3000490874, 3000491430, 3000491431, 3000491432, 3000491433, 3000493065, 3000493066, 3000493067, 3000493068, 3000496199, 3000496200, 3000496201, 3000496202, 3000496203, 3000498673, 3000498674, 3000498834, 3000501303, 3000501304, 3000501305, 3000501307, 3000502840, 3000502841, 3000502843, 3000502844, 3000503939, 3000503942, 3000503943, 3000510425, 3000510426, 3000510427, 3000511848, 3000511849, 3000511850, 3000513501, 3000513502, 3000513503, 3000513504, 3000513505, 3000514609, 3000514610, 3000514611, 3000514612, 3000515696, 3000515697, 3000515698, 3000515699, 3000517998, 3000518004, 3000518005, 3000519528, 3000519529, 3000519530, 3000519531, 3000519532, 3000520745, 3000520746, 3000520747, 3000520748, 3000522411, 3000522412, 3000522413, 3000522414, 3000522415, 3000523510, 3000523511, 3000524539, 3000524540, 3000524541, 3000525039, 3000525040, 3000525041, 3000525042, 3000525043, 3000525460, 3000525461, 3000525462, 3000525463, 3000526919, 3000526920, 3000526921, 3000526922, 3000528714, 3000528715, 3000528716, 3000530042, 3000530043, 3000530044, 3000530045, 3000534004, 3000534005, 3000534006, 3000535444, 3000535445, 3000535446, 3000535447, 3000537045, 3000537046, 3000537047, 3000537048, 3000539525, 3000539526, 3000539527, 3000539528, 3000541228, 3000541229, 3000541230, 3000541231, 3000541232, 3000543979, 3000543986, 3000543989, 3000547001, 3000547002, 3000547003, 3000547004, 3000549189, 3000549190, 3000549191, 3000550936, 3000550937, 3000550938, 3000550939, 3000553331, 3000553332, 3000553333, 3000553334, 3000553335, 3000554727, 3000554729, 3000554730, 3000556412, 3000556413, 3000556414, 3000556415;
Quantity
185617 units (5926 US, 179691 OUS)
Classification
Class II
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
FDA recall number
Z-3146-2026
Codes, lots and dates
Model Number (USA): 701054427; UDI-DI: 4037691746517; Lot Numbers: 3000324476, 3000326923, 3000331200, 3000333822, 3000353373, 3000359477, 3000364060, 3000373784, 3000379853, 3000393466, 3000403658, 3000413596, 3000434593, 3000444270, 3000449725, 3000453328, 3000478750, 3000524542; Model Number (OUS): 701054427; UDI-DI: 4037691746517; Lot Numbers: 3000324476, 3000326923, 3000331200, 3000333821, 3000333822, 3000341452, 3000349478, 3000353373, 3000356330, 3000359477, 3000364060, 3000370472, 3000373784, 3000379853, 3000387894, 3000389007, 3000393466, 3000395576, 3000403658, 3000411197, 3000413596, 3000418475, 3000434593, 3000438011, 3000441822, 3000444270, 3000449725, 3000453328, 3000461221, 3000466027, 3000468435, 3000471532, 3000478750, 3000485149, 3000489899, 3000501535, 3000508513, 3000518008, 3000524542, 3000525465, 3000526923, 3000534009, 3000539532, 3000541224;
Quantity
16697 units (492 USA, 16205 OUS)
Classification
Class II

Exactly as the agency lists them

Identifiers and details

FDA event ID: 99668
Initiated: Voluntary: Firm initiated
Status: Ongoing
Firm location: Rastatt, N/A, Germany

Why it was recalled

The reason the FDA lists: “The packaging may not consistently maintain sterile barrier integrity.”

Where it was sold

Nationwide. Distribution as the FDA records it: “Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom;”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99668, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

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FAQ

About this recall

Is Maquet Cardiopulmonary Percutaneous Insertion Kit recalled?

Yes. Maquet Cardiopulmonary Gmbh recalled it on July 31, 2026; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it recalled?

The packaging may not consistently maintain sterile barrier integrity.

What should I do if I have it?

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.