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Maquet Cardiovascular Us Sales, Llc
Maquet Cardiovascular Us Sales, Llc: 62 FDA recall reports
Every medical device recall the FDA has published for Maquet Cardiovascular Us Sales, Llc. The fault, and how the agency graded it.
62Reports
7Class I
0Ongoing
2020-12-23Most recent
7 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Pr
Z-0632-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
- Product
- 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.
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Mexico, Moldavia, Montenegro, Morocco, Myanmar, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand,Turkey, United Arab Emirates, United Kingdom, Vietnam.
- How much
- 58,438 devices worldwide
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product
Z-0633-2021 · Class II · reported 2020-12-23 · Terminated
- Why it was recalled
- The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
- Product
- 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.
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Mexico, Moldavia, Montenegro, Morocco, Myanmar, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand,Turkey, United Arab Emirates, United Kingdom, Vietnam.
- How much
- N/A
Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during car
Z-0443-2021 · Class II · reported 2020-11-18 · Terminated
- Why it was recalled
- The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit board (PCB) where as the standard requires a creepage distance of 4 mm.
- Product
- 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).
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, IA, MD, NC, PA, TX, WA, WI and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Italy, Jordan, Malaysia, Malta, Netherlands, Norway, Pakistan, Peru, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela.
- How much
- 51 units
Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before,
Z-0132-2021 · Class II · reported 2020-10-28 · Terminated
- Why it was recalled
- Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still connected to the main socket (power source), there is a risk that a user or third person may suffer an electric shock when coming in contact with the exposed electronic components
- Product
- 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)
- Where it went
- Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, FINLAND, FRANCE GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, MACAU, MACEDONIA, MALAYSIA, MEXICO, NEW ZEALAND, OMAN, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, RWANDA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TUNESIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM.
- How much
- 62 units US
Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during an
Z-0133-2021 · Class II · reported 2020-10-28 · Terminated
- Why it was recalled
- Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still connected to the main socket (power source), there is a risk that a user or third person may suffer an electric shock when coming in contact with the exposed electronic components
- Product
- 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)
- Where it went
- Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, FINLAND, FRANCE GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, MACAU, MACEDONIA, MALAYSIA, MEXICO, NEW ZEALAND, OMAN, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, RWANDA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TUNESIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM.
- How much
- 6 units US
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal
Z-2957-2020 · Class III · reported 2020-09-23 · Terminated
- Why it was recalled
- Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition
- Product
- 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
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of ME, NY, NV, OH, TX, VA, WA and the countries of China, Colombia, India, Italy, Mexico, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Arabic Emirates, United Kingdom.
- How much
- 105 total: US: 11 each OUS: 94 each
Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495
Z-2780-2020 · Class II · reported 2020-08-19 · Terminated
- Why it was recalled
- Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.
- Product
- 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.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of OH, PA, SC, CT and the countries of Germany, Spain, France, United Kingdom, Italy, United Arab Emirates, Mexico, Canada, Croatia, Georgia, Poland, Slovakia, Thailand, and Vietnam.
- How much
- 50 units
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Z-1603-2020 · Class II · reported 2020-04-08 · Terminated
- Why it was recalled
- A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.
- Product
- Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
- Where it went
- Domestic distribution only to the following states: AL AZ CA CT FL GA IL MA MI NC NH NM NY OH OK TN TX VA
- How much
- 255
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part
Z-1475-2020 · Class II · reported 2020-03-18 · Terminated
- Why it was recalled
- Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water
- Product
- Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
- Where it went
- Nationwide Foreign: Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Iran, Ireland, Israel, Italy, Japan, Kenya, Lithuania, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom
- How much
- 146 US
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such
Z-1390-2020 · Class III · reported 2020-03-04 · Terminated
- Why it was recalled
- Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
- Product
- 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.
- Where it went
- U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
- How much
- 4 units
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such
Z-1391-2020 · Class III · reported 2020-03-04 · Terminated
- Why it was recalled
- Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
- Product
- 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.
- Where it went
- U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
- How much
- 7 units
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the
Z-0678-2020 · Class II · reported 2019-12-18 · Terminated
- Why it was recalled
- A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
- Product
- Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
- Where it went
- The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.
- How much
- 11 distributed in the US
Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 70105279
Z-2149-2019 · Class II · reported 2019-09-25 · Terminated
- Why it was recalled
- The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.
- Product
- Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
- Where it went
- The products were distributed to the following US states: AR, CA, FL, GA, IA, IL, IN, KY, NC, NE, NM, NV, NY, OH, OR, TN, and WI.
- How much
- 54
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
Z-1864-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 10 units
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
Z-1860-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 11 units
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
Z-1857-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 2 units
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
Z-1856-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 7 units
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
Z-1858-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 6 units
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
Z-1855-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 46 units
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
Z-1859-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 12 units
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
Z-1852-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 2 units
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
Z-1853-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 11 units
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
Z-1861-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 5 units
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
Z-1863-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 9 units
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
Z-1854-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 65 units
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
Z-1862-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
- Where it went
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
- How much
- 2 units
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge
Z-1777-2019 · Class II · reported 2019-06-19 · Terminated
- Why it was recalled
- Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.
- Product
- 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.
- Where it went
- Worldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA Foreign: Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine
- How much
- 4 units
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Ser
Z-1778-2019 · Class II · reported 2019-06-19 · Terminated
- Why it was recalled
- Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.
- Product
- 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.
- Where it went
- Worldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA Foreign: Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine
- How much
- 40 units
GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 72
Z-1734-2019 · Class II · reported 2019-06-12 · Terminated
- Why it was recalled
- User may suffer an electric shock when coming in contact with the exposed electronic components
- Product
- 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.
- Where it went
- Worldwide - US Nationwide Distribution Foreign: ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BOLIVIA BOTSWANA BOSNIA AND HERZEGOVINA BRAZIL BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GABON GERMANY GREECE HONG KONG HONDURAS HUNGARY ICELAND INDIA IRAN IRELAND ISRAEL ITALY JAPAN JORDAN KUWAIT LATVIA LEBANON LITHUANIA MACEDONIA MALAYSIA MAURITIUS MEXICO MOLDAVA MONTENEGRO MOROCCO MYANMAR NETHERLANDS NAMIBIA NORWAY NEW ZEALAND PAKISTAN PARAGUAY PERU PHILIPPINES POLAND PORTUGAL ROMANIA SAUDI ARABIA SERBIA SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND SYRIA TAIWAN TANZANIA THAILAND TURKEY TURKMENISTAN UKRAINE UNITED ARAB EMIRATES URUGUAY UNITED KINGDOM VIETNAM
- How much
- U.S: 163; Foreign: 1864. Expanded: US:27 Foreign: 455
Class I
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in e
Z-0986-2019 · Class I · reported 2019-04-03 · Terminated
- Why it was recalled
- Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.
- Product
- 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.
- Where it went
- US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.
- How much
- 10
Showing the 30 most recent of 62. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls