thejoe Maquet Medical Systems USA

Maquet Medical Systems USA: 41 FDA recall reports

Every medical device recall the FDA has published for Maquet Medical Systems USA. The fault, and how the agency graded it.

41Reports

1Class I

35Ongoing

2024-05-22Most recent

1 Class I on this page

Class 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	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

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

Class	Reports
Class II	39
Class I	1
Class III	1

By year reported

Year	Reports
2012	1
2013	1
2014	1
2015	1
2016	1
2021	1
2022	5
2023	24
2024	6

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.

CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.

Z-1831-2024 · Class II · reported 2024-05-22 · Ongoing

Why it was recalled: The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Product: CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Where it went: US Nationwide distribution in the states of NJ & TX.
How much: 148 units (US: 5; OUS: 143)

BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-

Z-1077-2024 · Class II · reported 2024-02-21 · Ongoing

Why it was recalled: The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Product: BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Where it went: Worldwide - US Nationwide distribution.
How much: 16520 worldwide; 6657 US

Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOH

Z-1076-2024 · Class II · reported 2024-02-21 · Ongoing

Why it was recalled: The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Product: Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Where it went: Worldwide - US Nationwide distribution.
How much: 16520 worldwide; 6657 US

Bubble Sensor (REF: 70105.5720)

Z-1053-2024 · Class II · reported 2024-02-14 · Ongoing

Why it was recalled: The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
Product: Bubble Sensor (REF: 70105.5720)
Where it went: AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.
How much: 274 units (70 US, 204 OUS)

BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracor

Z-0978-2024 · Class II · reported 2024-02-14 · Ongoing

Why it was recalled: Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
Product: BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Where it went: Worldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC, NY, OH, OR, PA, TX, UT, VA and the countries of Canada, Germany, Italy, Japan, and Netherlands.
How much: 1090 total

BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracor

Z-0977-2024 · Class II · reported 2024-02-14 · Ongoing

Why it was recalled: Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
Product: BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Where it went: Worldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC, NY, OH, OR, PA, TX, UT, VA and the countries of Canada, Germany, Italy, Japan, and Netherlands.
How much: 1090 total

Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 70

Z-0605-2024 · Class II · reported 2023-12-27 · Ongoing

Why it was recalled: Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to inappropriate blood flow, blood temperature, or hematocrit/hemoglobin levels as a result of the CARDIOHELP-i not receiving information from the venous probe.
Product: Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Where it went: Domestic distribution Nationwide. Foreign distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Canada, Cayman Islands, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Islamic Republic Of Iraq, Italy, Japan, Kazakhstan, Korea, Republic Of Kuwait, Latvia, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Martinique, Mauritius, Mayotte, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.
How much: 1213 US, 2589 OUS

CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood

Z-0595-2024 · Class III · reported 2023-12-27 · Ongoing

Why it was recalled: CARDIOHELP-i System was not properly tested to measure leakage current
Product: CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012
Where it went: Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iran, Islamic Republic Of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Macao, Maldives, Martinique, Mayotte, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom,Vietnam, Yemen
How much: 1594 units

CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blo

Z-0555-2024 · Class II · reported 2023-12-20 · Ongoing

Why it was recalled: Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp
Product: CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)
Where it went: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Brunei, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Maldives, Martinique, Mauritius, Mayotte, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Republic of Korea, R¿union, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.
How much: 1595 units

Class I

CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation

Z-0420-2024 · Class I · reported 2023-12-13 · Ongoing

Why it was recalled: Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.
Product: CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Where it went: US Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC, FL, HI, IA, IL, IN, KY, MD, MI, MN, MO, NE, OH, SC, VA Foreign distribution to: Austria, Australia, Brazil, Canada, Chile, China, Czech Republic, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Jordan, Mexico, New Zealand, Pakistan, Portugal, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom
How much: Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S.

Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 7010

Z-0290-2024 · Class II · reported 2023-11-15 · Ongoing

Why it was recalled: It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.
Product: Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Where it went: US Nationwide.
How much: 1022 units

QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model

Z-1660-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Product: QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Where it went: Nationwide domestic distribution
How much: 0 (US)

QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Ite

Z-1657-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Product: QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895
Where it went: Nationwide domestic distribution
How much: 1,784 (US)

QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO

Z-1641-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Product: QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Where it went: Domestic distribution nationwide.
How much: 0 (US)

BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905

Z-1636-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Product: BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
Where it went: Domestic distribution nationwide.
How much: 1,784 (US)

QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO

Z-1640-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Product: QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Where it went: Domestic distribution nationwide.
How much: 0 (US)

QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model It

Z-1659-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Product: QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829
Where it went: Nationwide domestic distribution
How much: 0 (US)

QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No.

Z-1656-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Product: QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
Where it went: Nationwide domestic distribution
How much: 24,250 (US)

QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model

Z-1658-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Product: QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
Where it went: Nationwide domestic distribution
How much: 5,022 (US)

BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859

Z-1635-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Product: BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Where it went: Domestic distribution nationwide.
How much: 15,880 (US)

QUADROX-iR, used during cardiopulmonary bypass Model Item No. Descrip

Z-1643-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Product: QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating
Where it went: Domestic distribution nationwide.
How much: 0 (US)

QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 700

Z-1638-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Product: QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823
Where it went: Domestic distribution nationwide.
How much: 0 (US)

QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item

Z-1655-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Product: QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Where it went: Nationwide domestic distribution
How much: 0 (US)

QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO

Z-1637-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Product: QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895
Where it went: Domestic distribution nationwide.
How much: 0 (US)

Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item N

Z-1642-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Product: Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Where it went: Domestic distribution nationwide.
How much: 0 (US)

Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model

Z-1661-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Product: Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Where it went: Nationwide domestic distribution
How much: 0 (US)

QUADROX-iR, used during cardiopulmonary bypass Model Item No.

Z-1662-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Product: QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating
Where it went: Nationwide domestic distribution
How much: 0 (US)

BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829

Z-1639-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Product: BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
Where it went: Domestic distribution nationwide.
How much: 0 (US)

HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840

Z-1634-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Product: HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
Where it went: Domestic distribution nationwide.
How much: 8,670 (US)

BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, P

Z-1188-2023 · Class II · reported 2023-03-08 · Ongoing

Why it was recalled: Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.
Product: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
Where it went: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czechia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Myanmar, Mexico, Moldova, Morocco, Namibia, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of North Macedonia, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, The Republic of Korea, The Russian Federation, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam.
How much: 10,587 units (US); 94,987 (worldwide)

Showing the 30 most recent of 41. 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