PlainRecalls

Maquet Cardiovascular Us Sales, Llc

62 recalls on record · Latest: Dec 23, 2020

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Agency notice ledger

Federal filing book Maquet Cardiovascular Us Sa… MID-BOOK · SINGLE-AGENCY

#289 of 14,151 · 62 notices · 0.059% archive

  • BOOK 62 notices
  • RANK #289 of 14,151
  • SHARE 0.059% archive
  • AGENCY FDA Devices (62)
  • CAT medical devices
  • CATS 1 category
  • LATEST Dec 23, 2020
  • PHOTO Edge Pharma, LLC

Nearest notice-volume peer: Edge Pharma, LLC (0 notice gap)

Maquet Cardiovascular Us Sales, Llc accounts for about 0.059% of the 104,423-notice archive on 62 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Maquet Cardiovascular Us Sa… compares to 14,151 recalling firms

Maquet Cardiovascular Us Sales, Llc ranks 289th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Maquet Cardiovascular Us Sa… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

62 289th of 14151 higher than 13,861 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Maquet Cardiovascular Us Sa… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Maquet Cardiovascular Us Sales, Llc holds about 0.059% of archive notices alongside 62 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Dec 23, 2020

HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.

FDA Devices Moderate Dec 23, 2020

HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.

FDA Devices Moderate Nov 18, 2020

Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).

FDA Devices Moderate Oct 28, 2020

Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS)

FDA Devices Moderate Oct 28, 2020

Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143302F0 (US) Part 143302B0 (OUS)

FDA Devices Low Sep 23, 2020

Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292

FDA Devices Moderate Aug 19, 2020

Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric Oxygenator and can also be used in combination with the holder's arm (016061) to use in cardiopulmonary bypass procedures (CPB) in a pediatric patient population.

FDA Devices Moderate Apr 8, 2020

Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039

FDA Devices Moderate Mar 18, 2020

Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203

FDA Devices Low Mar 4, 2020

Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.

FDA Devices Low Mar 4, 2020

Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.

FDA Devices Moderate Dec 18, 2019

Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

FDA Devices Moderate Sep 25, 2019

Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP

FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF

FDA Devices Moderate Jun 19, 2019

Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

FDA Devices Moderate Jun 19, 2019

Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

FDA Devices Moderate Jun 12, 2019

GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.

FDA Devices Critical Apr 3, 2019

Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.

FDA Devices Critical Dec 5, 2018

QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

FDA Devices Critical Dec 5, 2018

QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

FDA Devices Moderate Nov 9, 2016

Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

FDA Devices Moderate Sep 14, 2016

The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. The fixture is used to adapt a range of different head and horseshoe head rests with a central square mount

FDA Devices Moderate Apr 20, 2016

Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator

FDA Devices Moderate Apr 20, 2016

QUADROX-i oxygenators Custom tubing packs for the oxygenator

FDA Devices Moderate Apr 20, 2016

HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator

FDA Devices Moderate Apr 20, 2016

Custom Tubing Packs Custom tubing pack for oxygenators

FDA Devices Moderate Mar 9, 2016

Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table.

FDA Devices Critical Mar 2, 2016

Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia adminis

FDA Devices Moderate Jan 13, 2016

Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

FDA Devices Moderate Nov 18, 2015

Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning elements stabilize the upper body while simultaneously relieving the abdominal region in the verti

FDA Devices Moderate Nov 18, 2015

Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning elements stabilize the upper body while simultaneously relieving the abdominal regio

FDA Devices Moderate Jul 29, 2015

Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.

FDA Devices Moderate Jul 22, 2015

The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.The system is intended for use in a wide range of population: from neonatal to adult patients. The system is intended for use in hospital environments, except for the MRI environm

FDA Devices Moderate Jul 15, 2015

The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.

FDA Devices Critical Jun 17, 2015

FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.

FDA Devices Moderate Jun 3, 2015

Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules ar

FDA Devices Moderate Jun 3, 2015

HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support

FDA Devices Moderate Mar 11, 2015

Servo-I ventilator system CO2 analyzer. Part number 65 23 588.

Maquet Cardiovascular Us Sa… carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (62 here — heavy-book).

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Frequently Asked Questions

How many federal recall notices name Maquet Cardiovascular Us Sa…?
PlainRecalls indexes 62 distinct federal recall events naming Maquet Cardiovascular Us Sales, Llc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Maquet Cardiovascular Us Sa… sit among other recalling firms?
Maquet Cardiovascular Us Sales, Llc ranks #289 of 14,151 by distinct recall-event count among 14,151 firms in this archive (98th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Maquet Cardiovascular Us Sa…'s notices?
FDA Devices accounts for 62 of this firm's 62 indexed notices.
What product category dominates Maquet Cardiovascular Us Sa…'s filing book?
Filings for Maquet Cardiovascular Us Sales, Llc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous?
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Maquet Cardiovascular Us Sales, Llc: 62 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Maquet Cardiovascular Us Sales, Llc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026