Open, ClassifiedPosted Mar 3, 2025·Initiated Jan 31, 2025
MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Reason: All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Root cause: Device Design
Recalling firm: Medtronic MiniMed, Inc.Type: Pump, Infusion, Insulin, To Be Used With Invasive Glucose SensorDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY and the countries of Algeria, Andorra, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State Of Bosnia, Herzegovina , Botswana, Brazil, Brunei, Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Cayman, Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic, Republic Of Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malawi, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Republic Of Montenegro, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion Romania, Russia, Saint Pierre And Miquelon, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Tanzania, United Republic Of Thailand, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian Republic Of Vietnam, Yemen, Zimbabwe.Recall #Z-1263-2025 Open, ClassifiedPosted Mar 3, 2025·Initiated Jan 31, 2025
MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
Reason: All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Root cause: Device Design
Recalling firm: Medtronic MiniMed, Inc.Type: Pump, Infusion, Insulin, To Be Used With Invasive Glucose SensorDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY and the countries of Algeria, Andorra, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State Of Bosnia, Herzegovina , Botswana, Brazil, Brunei, Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Cayman, Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic, Republic Of Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malawi, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Republic Of Montenegro, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion Romania, Russia, Saint Pierre And Miquelon, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Tanzania, United Republic Of Thailand, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian Republic Of Vietnam, Yemen, Zimbabwe. Open, ClassifiedPosted Mar 3, 2025·Initiated Jan 31, 2025
MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
Reason: All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Root cause: Device Design
Recalling firm: Medtronic MiniMed, Inc.Type: Automated Insulin Dosing Device System, Single Hormonal ControlDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY and the countries of Algeria, Andorra, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State Of Bosnia, Herzegovina , Botswana, Brazil, Brunei, Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Cayman, Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic, Republic Of Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malawi, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Republic Of Montenegro, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion Romania, Russia, Saint Pierre And Miquelon, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Tanzania, United Republic Of Thailand, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian Republic Of Vietnam, Yemen, Zimbabwe. Open, ClassifiedPosted Mar 3, 2025·Initiated Jan 31, 2025
MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
Reason: All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Root cause: Device Design
Recalling firm: Medtronic MiniMed, Inc.Type: Automated Insulin Dosing Device System, Single Hormonal ControlDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY and the countries of Algeria, Andorra, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State Of Bosnia, Herzegovina , Botswana, Brazil, Brunei, Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Cayman, Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic, Republic Of Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malawi, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Republic Of Montenegro, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion Romania, Russia, Saint Pierre And Miquelon, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Tanzania, United Republic Of Thailand, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian Republic Of Vietnam, Yemen, Zimbabwe. Open, ClassifiedPosted Feb 28, 2025·Initiated Jan 5, 2025
VARIPULSE Bi-Directional Ablation Catheter REF D141201.
The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System.
Reason: Due to an observed trend of neurovascular events
Root cause: Labeling design
Recalling firm: Biosense Webster, Inc.Type: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationDistribution: Worldwide distribution; US states of AR, CA, CO, KS, LA, MA, MO, NY, OH and TX.
EMEA, New Zealand, Saudi Arabia, Oman, United Ecuador, Panama, South Africa, China
Austria
Belgium
Czech Republic
France
Germany
Hungary
Ireland
Israel
Italy
UK
Sweden
Norway
Denmark
Finland
Luxembourg
Netherlands
Poland
Portugal
Slovenia
Spain
Switzerland
Serbia
United Arab Emirates
Croatia
Canada
South Korea
JapanRecall #Z-1205-2025
Open, ClassifiedPosted Feb 28, 2025·Initiated Jan 31, 2025
SIGNA Creator, SIGNA Explorer, NMRI systems
Reason: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Root cause: Software design
Recalling firm: GE Healthcare (China) Co., Ltd.Type: System, Nuclear Magnetic Resonance ImagingDistribution: Domestic US distribution nationwide.
International distribution worldwide.Recall #Z-1239-2025
Open, ClassifiedPosted Feb 28, 2025·Initiated Jan 31, 2025
Brivo MR355, NMRI system
Reason: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Root cause: Software design
Recalling firm: GE Healthcare (China) Co., Ltd.Type: System, Nuclear Magnetic Resonance ImagingDistribution: Domestic US distribution nationwide.
International distribution worldwide.Recall #Z-1240-2025
Open, ClassifiedPosted Feb 28, 2025·Initiated Jan 31, 2025
Optima MR360, NMRI system
Reason: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Root cause: Software design
Recalling firm: GE Healthcare (China) Co., Ltd.Type: System, Nuclear Magnetic Resonance ImagingDistribution: Domestic US distribution nationwide.
International distribution worldwide.Recall #Z-1241-2025
Open, ClassifiedPosted Feb 28, 2025·Initiated Jan 31, 2025
SIGNA MR355, SIGNA MR360, NMRI system
Reason: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Root cause: Software design
Recalling firm: GE Healthcare (China) Co., Ltd.Type: System, Nuclear Magnetic Resonance ImagingDistribution: Domestic US distribution nationwide.
International distribution worldwide.Recall #Z-1242-2025
Open, ClassifiedPosted Feb 28, 2025·Initiated Jan 31, 2025
SIGNA MR380, NMRI system, Non-US Only
Reason: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Root cause: Software design
Recalling firm: GE Healthcare (China) Co., Ltd.Type: System, Nuclear Magnetic Resonance ImagingDistribution: Domestic US distribution nationwide.
International distribution worldwide.Recall #Z-1243-2025
Open, ClassifiedPosted Feb 28, 2025·Initiated Feb 3, 2025
Access Erythropoietin (EPO), Catalog Number - A16364
a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis)
in mammals. Renal production of EPO is regulated by changes in oxygen
availability. Under conditions of hypoxia, the level of EPO in the circulation
increases and this leads to increased production of red blood cells.
Reason: Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.
Root cause: Unknown/Undetermined by firm
Recalling firm: Beckman Coulter, Inc.Type: Assay, ErythropoietinDistribution: Domestic distribution to AL
AR
AZ
CA
CT
FL
ID
IL
IN
KS
MA
MI
NC
NE
NJ
NY
OH
OR
PA
TN
TX
UT
WA
WV.
International distribution to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada,
China, Czechia, Denmark, France, Germany, Hungary, India,
Italy, Japan, Korea, Republic of, Netherlands, Philippines,
Russian Federation, Saudi Arabia, Slovakia, Spain, United
Kingdom of Great Britain and Northern IrelandRecall #Z-1249-2025
Open, ClassifiedPosted Feb 28, 2025·Initiated Feb 3, 2025
Brand Name: TBS Osteo
Product Name: TBS iNsight
Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi
Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0
Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management
Component: No
Reason: Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
Root cause: Software Design Change
Recalling firm: Medimaps GroupType: Densitometer, BoneDistribution: Domestic: AL, AZ, CA, CO, DE, FL, IL, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, PA, SC, TX, UT, WA.
International: ALGERIA, ANDORRA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, CHILE, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, SOUTH KOREA, LEBANON, MALAYSIA, MEXICO, MONTENEGRO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAYRecall #Z-1250-2025
Open, ClassifiedPosted Feb 28, 2025·Initiated Oct 18, 2024
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Reason: The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.
Root cause: Process control
Recalling firm: HUMAN MED AGType: System, Suction, Lipoplasty For RemovalDistribution: US Nationwide distribution in the state of FL.Recall #Z-1251-2025
Open, ClassifiedPosted Feb 28, 2025·Initiated Apr 4, 2024
Philips IntelliSpace Cardiovascular software, Model 830089.
Reason: Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Root cause: Software design
Recalling firm: Philips Medical Systems Nederland B.V.Type: System, Image Processing, RadiologicalDistribution: US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.Recall #Z-1252-2025
Open, ClassifiedPosted Feb 27, 2025·Initiated Jan 30, 2025
Brand Name: Leica Biosystems Cryostats
Product Name: CM1950
Model/Catalog Number: 1491950C4US
Software Version: firmware V3.01
Reason: Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Root cause: Under Investigation by firm
Recalling firm: LEICA BIOSYSTEMS NUSSLOCH GMBHType: Microtome, CryostatDistribution: Worldwide - US Nationwide distribution in the states of Idaho and Ohio. The countries of France, Australia, Belgium, China, Germany, Spain, UK, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, Singapore.Recall #Z-1247-2025
Open, ClassifiedPosted Feb 27, 2025·Initiated Jan 15, 2025
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Reason: Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Root cause: Labeling False and Misleading
Recalling firm: TERRAGENE S.A.Type: Indicator, Biological Sterilization ProcessDistribution: US Nationwide distribution in the states of CA and KY.Recall #Z-1248-2025 Open, ClassifiedPosted Feb 26, 2025·Initiated Feb 3, 2025
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Reason: Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.
Root cause: Component change control
Recalling firm: Ventec Life Systems, Inc.Type: Ventilator, Continuous, Facility UseDistribution: US distribution in CA, NY, and MO.Recall #Z-1196-2025
Open, ClassifiedPosted Feb 26, 2025·Initiated Jan 2, 2025
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001
The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
Reason: Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Scientia Vascular, Inc.Type: Catheter, Thrombus RetrieverDistribution: U..S. Nationwide distribution in the states of AL, AZ, FL, GA, HI, IL, IN, KS, MN, NC, NJ, NY, PA, SD, TX, VA, WI and WV.Recall #Z-1234-2025
Open, ClassifiedPosted Feb 26, 2025·Initiated Jan 16, 2025
Plato 17 Microcatheter REF PL17-160-090
To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
Reason: Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Scientia Vascular, Inc.Type: Catheter, Percutaneous, NeurovasculatureDistribution: U.S. Nationwide distribution in the state of DE.Recall #Z-1235-2025
Open, ClassifiedPosted Feb 26, 2025·Initiated Jan 29, 2025
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract
Model: EC38-i20cL
Reason: During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
Root cause: Device Design
Recalling firm: Pentax of America IncType: Endoscope, Accessories, Image Post-Processing For Color EnhancementDistribution: NationwideRecall #Z-1236-2025