FDA Class II · Medical device · Recall Z-3145-2026 · Recalled September 23, 2026
Percutaneous Insertion Kit (PIK) recall — Maquet Cardiopulmonary Gmbh Compare identifiers Agency action Open official record ↗ Agency report date: September 23, 2026.
Source checks: October 22, 2026 at 6:00 PM UTC (oldest successful check).
Sources, dates and coverage limits We collect recent notices on a six-hour schedule using a rolling 90-day source request. Older retained records may also appear. This is a recall index, not a catalogue of all products or a complete recall history.
FDA: stored recall dates April 29, 2026 to October 14, 2026. USDA FSIS is not aggregated here. Check USDA meat, poultry and processed egg notices . EPA and U.S. Coast Guard are not aggregated. Source delays and missing identifiers can prevent a match.
1. Compare your item This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named Percutaneous Insertion Kit (PIK) Company / brand Maquet Cardiopulmonary Lot / serial / date codes 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; Distribution 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; Agency product description and boundaries Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action FDA reports: The packaging may not consistently maintain sterile barrier integrity.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: Percutaneous Insertion Kit (PIK) recall status
3. Open the official notice or contact View the official FDA enforcement record (openFDA) ↗
Official recall ID Z-3145-2026 Brand All Maquet Cardiopulmonary recalls Classification Class II Units affected 185617 units (5926 US, 179691 OUS) Recall status Ongoing Initiated Voluntary: Firm initiated Affected products Companies & origin Recalling firm location Rastatt, N/A, Germany Firm address Kehler Str. 31, N/A, N/A Identifying details (verbatim from the notice) Product codes / lots 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; Distribution 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; Firm notified the public via Letter FDA event ID 99668 Recall initiated July 31, 2026 FDA classified September 11, 2026 FDA report date September 23, 2026 Other medical device recalls from around the same time INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recall — CooperSurgical, Inc. FDA · September 30, 2026 INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP recall — CooperSurgical, Inc. FDA · September 30, 2026 Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall — AVID Medical, Inc. FDA · September 23, 2026 Haylard BASIC BIOPSY TRAY recall — AVID Medical, Inc. FDA · September 23, 2026 Haylard CONTINUOUS NERVE BLOCK TRAY recall — AVID Medical, Inc. FDA · September 23, 2026
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes;
the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.
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