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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Vascular Solutions, Inc.: The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Agency Publication Date: October 20, 2020
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Affected Products

Product: Langston Dual Lumen Catheter

Model Number: 5515, UDI 10841156100506 Lot Numbers: 635806, 640206, 644140, 648701, 654143, 658252, 659635, 661470, 665301, 670376, 654130, 672728, 656020, 638111, 677058.

Lot Numbers:
Numbers
Product: Langston Dual Lumen Catheter.

Model Number: 5540, UDI, 10841156100513, Lots 643376, 633647, 639516, 645032, 649315, 650991, 656191, 658151, 659443, 660590, 666438, 670586, 672660, 635207, 636898, 643051, 644573, 645360, 645482, 648481, 649729, 650018, 650873, 651457, 653053, 655645, 655738, 657627, 658250, 658824, 659122, 659217, 660910, 661139, 663039, 663344, 665098, 665099, 666559, 668703, 671743, 671948, 672894, 633211, 635208, 635542, 636901, 637832, 644015, 646106, 649078, 650765, 654190, 657517, 657680, 660717, 662903, 663138, 665303, 667164, 669190, 647786, 671427, 634423, 634247, 648043, 648963, 651920, 653863, 660823, 662493, 661257, 650369, 638953, 669199, 658438, 668701, 636284, 640938, 641222, 641543, 641679, 642031, 650023, 654010, 655128, 657030, 660075, 663281, 663790, 663854, 635805, 659362, 668303, 666966, 632018, 635209, 643835, 645118, 646247, 647482, 649456, 652176, 653319, 656554, 659630, 661863, 662824, 665234, 669602, 647370, 648337, 672813, 664087, 657243, 652097, 668095, 636471, 640676, 642373, 642520, 644650, 654890, 655460, 657866, 658018, 661474, 662053, 662133, 664449, 667465, 668934, 670503, 672130, 663791, 635280, 669402, 632020, 638198, 639892, 640034, 648603, 653565, 654889, 658984, 662642, 671202, 643542, 645481, 672349, 635541, 661707, 666332, 670144, 654514, 654657, 671004, 671633,637388,645031, 646641, 650606, 670299, 642928, 670865, 639414, 642178, 646110, 651524, 660199, 668094, 669591, 641060, 647014, 651163, 655869, 656727 ,647697, 635861, 640459, 666067, 667936, 632019, 638323, 643874, 646108, 648210, 649584, 654340, 658541, 664236, 633929, 646640, 653443, 668305, 668771, 655287, 662265, 637384, 651829, 669737, 648780, 652777, 653776, 658671, 667832, 637945, 651278, 652628, 660288, 667151, 656801, 646879, 650560, 652459, 659855, 660397, 667835, 636709, 647206, 673021, 649315.

Product: Langston Dual Lumen Catheter.

Model Number: 5545, UDI 10841156100520 total 1745, Lots: 634357, 645111, 649740, 650126, 655647, 657411, 661790, 666866, 673313, 638819, 650127, 659802, 672219, 675001, 638547, 668503.

Product: Langston Dual Lumen Catheter.

Model Number: 5550, UDI 10841156100537 total 2990, Lots: 637973, 640204, 659555, 660597, 633668, 663767, 669593, 659856, 644096, 676528, 672481, 632704, 656792, 658273, 666755, 635885.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86433
Status: Resolved
Manufacturer: Vascular Solutions, Inc.
Manufactured In: United States
Units Affected: 4 products (1,680 units; 89,121 units; 1,745 units; 2990 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.