PlainRecalls

Maquet Cardiovascular Us Sales, Llc

46 recalls on record · Latest: Dec 23, 2020

Maquet Cardiovascular Us Sales, Llc Recall Insight

Maquet Cardiovascular Us Sales, Llc appears on 46 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.055% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 23, 2020, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 46 entries, severity tagging shows 5 critical, 39 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 46 of 46 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (46). The date window on this page runs from Jul 18, 2012 to Dec 23, 2020.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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 wit…

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…

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 intervention…

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 …

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 met…

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,…

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 Jun 19, 2019

Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector i…

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 desig…

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 7…

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 dispos…

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…

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 he…

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 ta…

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 Nov 18, 2015

Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elem…

FDA Devices Moderate Nov 18, 2015

Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Po…

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 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 …

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 populat…

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 extrac…

FDA Devices Moderate Dec 31, 2014

Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with…

FDA Devices Moderate Nov 19, 2014

Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass c…

FDA Devices Moderate Feb 5, 2014

Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the spec…

FDA Devices Moderate Oct 2, 2013

QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators a…

FDA Devices Moderate Jul 10, 2013

MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedur…

FDA Devices Moderate Jul 3, 2013

MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorpor…

FDA Devices Critical May 8, 2013

Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator S…

FDA Devices Moderate Nov 7, 2012

QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The Q…

FDA Devices Critical Jul 18, 2012

FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds