Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Gynecological Laparoscopic KitDistribution: US Nationwide. Canada.Recall #Z-0725-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; 4) CRANIOTOMY CDS, SKU CDS981753K; 5) LAMINECTOMY CDS-LF, SKU CDS981923X; 6) CRANIOTOMY, SKU CDS982719Q; 7) CRANIOTOMY, SKU CDS982719R; 8) CRANIOTOMY, SKU CDS982719S; 9) CRANIOTOMY, SKU CDS982719T; 10) CRANIOTOMY, SKU CDS982719U; 11) CRANIOTOMY, SKU CDS982719V; 12) CRANIOTOMY, SKU CDS982719W; 13) CRANIOTOMY, SKU CDS984074I; 14) SPINE, SKU CDS984943I; 15) SPINE, SKU CDS984943J; 16) KIT NEURO CRANIOTOMY FOR TUMOR, SKU DYKMBNDL144; 17) KIT NEURO CRANIOTOMY FOR TUMOR, SKU DYKMBNDL144A; 18) CRANIOTOMY #IMF 56646-LF, SKU DYNJVB91001; 19) NEURO SPINE #IMF 56655-LF, SKU DYNJVB91004; 20) CRANIOTOMY HARPER PACK-LF, SKU DYNJ0162022G; 21) CRANIOTOMY PACK-LF, SKU DYNJ0530906AP; 22) CRANIOTOMY PACK-LF, SKU DYNJ0530906AQ; 23) LAMINECTOMY PACK-LF, SKU DYNJ17452R; 24) LAMINECTOMY PACK-LF, SKU DYNJ17452S; 25) CRANIOTOMY PACK-LF, SKU DYNJ17455J; 26) CRANIOTOMY PACK-LF, SKU DYNJ17455K; 27) DEPAUL CRANIOTOMY-LF, SKU DYNJ20018P; 28) SPINAL PROCEDURE SC, SKU DYNJ33402K; 29) LAMINECTOMY PACK SC, SKU DYNJ35328J; 30) CRANIOTOMY PACK 9128175-LF, SKU DYNJ35982J; 31) LAMINECTOMY PACK, SKU DYNJ37683J; 32) SPINAL RECONSTRUCTION PACK, SKU DYNJ37689G; 33) CRANIOTOMY PACK, SKU DYNJ37714G; 34) CRANIOTOMY PACK, SKU DYNJ38317G; 35) SPINE PACK-LF, SKU DYNJ38889I; 36) ORTHO SPINE, SKU DYNJ40221A; 37) ORTHO SPINE, SKU DYNJ40221B; 38) ORTHO SPINE, SKU DYNJ40221C; 39) ORTHO SPINE, SKU DYNJ40221D; 40) ORTHO SPINE, SKU DYNJ40221F; 41) CRANIOTOMY PK, SKU DYNJ40388B; 42) CRANIOTOMY-LF, SKU DYNJ43319F; 43) NEURO SPINE PACK 319728, SKU DYNJ44628D; 44) CRANI PACK-LF, SKU DYNJ44805L; 45) LAMINECTOMY PACK-LF, SKU DYNJ44815J; 46) NEURO SPINE PACK, SKU DYNJ45419D; 47) NEURO SPINE PACK, SKU DYNJ45419F; 48) SPINE PACK, SKU DYNJ46317F; 49) CRANI PACK, SKU DYNJ47605B; 50) SCRIPPS SW CRANIOTOMY PACK-LF, SKU DYNJ49653C; 51) PK) NEURO-CRANI, SKU DYNJ53453A; 52) ACDF PACK-LF, SKU DYNJ57136A; 53) PEDI CRANI MAJOR, SKU DYNJ59338C; 54) UMC CRANIOTOMY, SKU DYNJ60497A; 55) UMC CRANIOTOMY PK, SKU DYNJ60497B; 56) CMC NEURO PACK-LF, SKU DYNJ61079C; 57) CMC NEURO PACK-LF, SKU DYNJ61079D; 58) CRANIOTOMY PK, SKU DYNJ65934B; 59) METREX PACK-LF, SKU DYNJ66104A; 60) CRANIOTOMY PACK, SKU DYNJ66419; 61) CRANIOTOMY PACK, SKU DYNJ66419A; 62) CRANIOTOMY PACK RFID, SKU DYNJ66419B; 63) CRANIOTOMY PACK, SKU DYNJ67355A; 64) CRANIOTOMY PACK, SKU DYNJ67355B; 65) OSC LAMINECTOMY PACK, SKU DYNJ67395; 66) SPINE PACK, SKU DYNJ67505F; 67) SPINE PACK, SKU DYNJ67505G; 68) SPINE PACK, SKU DYNJ67652A; 69) NEURO CRANI PACK, SKU DYNJ69752; 70) SPINE PACK, SKU DYNJ69753; 71) SPINE PACK, SKU DYNJ80550A; 72) CRANI PACK, SKU DYNJ80554A; 73) SPINE PACK, SKU DYNJ82105; 74) LAMINECTOMY I-LF, SKU DYNJ83783; 75) ANTERIOR CERVICAL-LF, SKU DYNJ83785; 76) NEURO-CRANI PK-LF, SKU DYNJ85475; 77) CRANIOTOMY PACK, SKU DYNJ85527A; 78) CRANIOTOMY-LF, SKU DYNJ900718D; 79) WMC ANTERIOR CERVICAL-LF, SKU DYNJ902443D; 80) WMC LAMINECTOMY-LF, SKU DYNJ902468J; 81) WMC LAMINECTOMY-LF, SKU DYNJ902468K; 82) WMC LAMINECTOMY-LF, SKU DYNJ902468L; 83) WMC LAMINECTOMY-LF, SKU DYNJ902468M; 84) WMC CRANIOTOMY ADD ON-LF, SKU DYNJ902473L; 85) CRANIOTOMY, SKU DYNJ903224R; 86) CRANIOTOMY, SKU DYNJ903224S; 87) CRANIOTOMY, SKU DYNJ903224T; 88) CRANIOTOMY, SKU DYNJ903224V; 89) DAVIS LAMI, SKU DYNJ903452D; 90) ORTHO INS-SPINE BACK, SKU DYNJ904661D; 91) ORTHO INS-SPINE ACDF, SKU DYNJ904662D; 92) CCOC SPINE EHRLER, SKU DYNJ904681F; 93) KIT) SPINE LH, SKU DYNJ906448B; 94) CRANI, SKU DYNJ906469F; 95) SPINE, SKU DYNJ907030; 96) JVL - MODULE BURR HOLE - CRAN, SKU DYNJ907147A; 97) BGMC MICRODISK-SPINAL, SKU DYNJ907349B; 98) KIT PEDI CRANI LAMI, SKU DYNJ907372A; 99) KIT SPINAL INSTRUMENTATION, SKU DYNJ907376; 100) SPINE, SKU DYNJ907819A; 101) UMC CRANIOTOMY, SKU DYNJ907945; 102)
Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Root cause: Nonconforming Material/Component
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Orthopedic TrayDistribution: US Nationwide. Canada.Recall #Z-0726-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 18, 2024
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit.
For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
Reason: Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay carryover due to insufficient washing. The contamination can cause a falsely elevated Access hsTnI result in subsequent sample(s) which can impact patient care (potentially but not limited to unnecessary coronary imaging or diagnostic catheterization) if the result is near the medical decision points.
Root cause: Component design/selection
Recalling firm: Beckman Coulter, Inc.Type: Immunoassay Method, Troponin SubunitDistribution: WorldwideRecall #Z-0727-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 8, 2024
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask
Product Code: 47117
Reason: Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Root cause: Nonconforming Material/Component
Recalling firm: O&M HALYARD, INC.Type: Mask, SurgicalDistribution: NationwideRecall #Z-0728-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 8, 2024
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask
Product Code: 47500
Reason: Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Root cause: Nonconforming Material/Component
Recalling firm: O&M HALYARD, INC.Type: Mask, SurgicalDistribution: NationwideRecall #Z-0729-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
Reason: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Root cause: Component change control
Recalling firm: Abbott Vascular IncType: Syringe, Balloon InflationDistribution: US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC.
OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.Recall #Z-0730-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Reason: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Root cause: Component change control
Recalling firm: Abbott Vascular IncType: Syringe, Balloon InflationDistribution: US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC.
OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.Recall #Z-0731-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Reason: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Root cause: Component change control
Recalling firm: Abbott Vascular IncType: Syringe, Balloon InflationDistribution: US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC.
OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.Recall #Z-0732-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 6, 2024
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
Reason: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Root cause: Component change control
Recalling firm: Abbott Vascular IncType: Syringe, Balloon InflationDistribution: US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC.
OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.Recall #Z-0733-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 22, 2024
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
Reason: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Root cause: Software design
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Nationwide
Foreign:
Albania
Angola
Argentina
Australia
Austria
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Cambodia
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Ecuador
Egypt
Estonia
Finland
France
Germany
Ghana
Greece
Guadeloupe
Hong Kong
Hungary
Iceland
India
Indonesia
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kazakhstan
Kuwait
Latvia
Lithuania
Luxembourg
Macau
Madagascar
Malaysia
Mexico
Monaco
Mongolia
Morocco
Myanmar
Netherlands
New Caledonia
New Zealand
Norway
Paraguay
Peru
Philippines
Poland
Portugal
Republic Korea
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Swaziland
Sweden
Switzerland
Thailand
Tunisia
Turkey
Ukraine
United Arab Emirates
United Kingdom Great Britain
Uruguay
VietnamRecall #Z-0734-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 22, 2024
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
Reason: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Root cause: Software design
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Nationwide
Foreign:
Albania
Angola
Argentina
Australia
Austria
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Cambodia
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Ecuador
Egypt
Estonia
Finland
France
Germany
Ghana
Greece
Guadeloupe
Hong Kong
Hungary
Iceland
India
Indonesia
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kazakhstan
Kuwait
Latvia
Lithuania
Luxembourg
Macau
Madagascar
Malaysia
Mexico
Monaco
Mongolia
Morocco
Myanmar
Netherlands
New Caledonia
New Zealand
Norway
Paraguay
Peru
Philippines
Poland
Portugal
Republic Korea
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Swaziland
Sweden
Switzerland
Thailand
Tunisia
Turkey
Ukraine
United Arab Emirates
United Kingdom Great Britain
Uruguay
VietnamRecall #Z-0735-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 22, 2024
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
Reason: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Root cause: Software design
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Nationwide
Foreign:
Albania
Angola
Argentina
Australia
Austria
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Cambodia
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Ecuador
Egypt
Estonia
Finland
France
Germany
Ghana
Greece
Guadeloupe
Hong Kong
Hungary
Iceland
India
Indonesia
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kazakhstan
Kuwait
Latvia
Lithuania
Luxembourg
Macau
Madagascar
Malaysia
Mexico
Monaco
Mongolia
Morocco
Myanmar
Netherlands
New Caledonia
New Zealand
Norway
Paraguay
Peru
Philippines
Poland
Portugal
Republic Korea
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Swaziland
Sweden
Switzerland
Thailand
Tunisia
Turkey
Ukraine
United Arab Emirates
United Kingdom Great Britain
Uruguay
VietnamRecall #Z-0736-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 22, 2024
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
Reason: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Root cause: Software design
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Nationwide
Foreign:
Albania
Angola
Argentina
Australia
Austria
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Cambodia
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Ecuador
Egypt
Estonia
Finland
France
Germany
Ghana
Greece
Guadeloupe
Hong Kong
Hungary
Iceland
India
Indonesia
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kazakhstan
Kuwait
Latvia
Lithuania
Luxembourg
Macau
Madagascar
Malaysia
Mexico
Monaco
Mongolia
Morocco
Myanmar
Netherlands
New Caledonia
New Zealand
Norway
Paraguay
Peru
Philippines
Poland
Portugal
Republic Korea
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Swaziland
Sweden
Switzerland
Thailand
Tunisia
Turkey
Ukraine
United Arab Emirates
United Kingdom Great Britain
Uruguay
VietnamRecall #Z-0737-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 22, 2024
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
Reason: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Root cause: Software design
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Nationwide
Foreign:
Albania
Angola
Argentina
Australia
Austria
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Cambodia
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Ecuador
Egypt
Estonia
Finland
France
Germany
Ghana
Greece
Guadeloupe
Hong Kong
Hungary
Iceland
India
Indonesia
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kazakhstan
Kuwait
Latvia
Lithuania
Luxembourg
Macau
Madagascar
Malaysia
Mexico
Monaco
Mongolia
Morocco
Myanmar
Netherlands
New Caledonia
New Zealand
Norway
Paraguay
Peru
Philippines
Poland
Portugal
Republic Korea
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Swaziland
Sweden
Switzerland
Thailand
Tunisia
Turkey
Ukraine
United Arab Emirates
United Kingdom Great Britain
Uruguay
VietnamRecall #Z-0738-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 22, 2024
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
Reason: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Root cause: Software design
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Nationwide
Foreign:
Albania
Angola
Argentina
Australia
Austria
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Cambodia
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Ecuador
Egypt
Estonia
Finland
France
Germany
Ghana
Greece
Guadeloupe
Hong Kong
Hungary
Iceland
India
Indonesia
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kazakhstan
Kuwait
Latvia
Lithuania
Luxembourg
Macau
Madagascar
Malaysia
Mexico
Monaco
Mongolia
Morocco
Myanmar
Netherlands
New Caledonia
New Zealand
Norway
Paraguay
Peru
Philippines
Poland
Portugal
Republic Korea
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Swaziland
Sweden
Switzerland
Thailand
Tunisia
Turkey
Ukraine
United Arab Emirates
United Kingdom Great Britain
Uruguay
VietnamRecall #Z-0739-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 22, 2024
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
Reason: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Root cause: Software design
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Nationwide
Foreign:
Albania
Angola
Argentina
Australia
Austria
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Cambodia
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Ecuador
Egypt
Estonia
Finland
France
Germany
Ghana
Greece
Guadeloupe
Hong Kong
Hungary
Iceland
India
Indonesia
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kazakhstan
Kuwait
Latvia
Lithuania
Luxembourg
Macau
Madagascar
Malaysia
Mexico
Monaco
Mongolia
Morocco
Myanmar
Netherlands
New Caledonia
New Zealand
Norway
Paraguay
Peru
Philippines
Poland
Portugal
Republic Korea
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Swaziland
Sweden
Switzerland
Thailand
Tunisia
Turkey
Ukraine
United Arab Emirates
United Kingdom Great Britain
Uruguay
VietnamRecall #Z-0740-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Nov 22, 2024
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9.
Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
Reason: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Root cause: Software design
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Nationwide
Foreign:
Albania
Angola
Argentina
Australia
Austria
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Cambodia
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Ecuador
Egypt
Estonia
Finland
France
Germany
Ghana
Greece
Guadeloupe
Hong Kong
Hungary
Iceland
India
Indonesia
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kazakhstan
Kuwait
Latvia
Lithuania
Luxembourg
Macau
Madagascar
Malaysia
Mexico
Monaco
Mongolia
Morocco
Myanmar
Netherlands
New Caledonia
New Zealand
Norway
Paraguay
Peru
Philippines
Poland
Portugal
Republic Korea
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Swaziland
Sweden
Switzerland
Thailand
Tunisia
Turkey
Ukraine
United Arab Emirates
United Kingdom Great Britain
Uruguay
VietnamRecall #Z-0741-2025 Open, ClassifiedPosted Dec 20, 2024·Initiated Oct 28, 2024
Galaxy System (GAL-001).
Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Reason: Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.
Root cause: Component change control
Recalling firm: Noah MedicalType: Bronchoscope (Flexible Or Rigid)Distribution: US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NCRecall #Z-0742-2025
Open, ClassifiedPosted Dec 20, 2024·Initiated Oct 2, 2024
TEMA Elbow - Axle Small REF 1590.15.010
TEMA Elbow - Axle Large REF 1590.15.020
TEMA Elbow System is a cemented total elbow prosthesis.
Reason: Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Root cause: Process control
Recalling firm: Limacorporate S.p.AType: Prosthesis, Elbow, Semi-Constrained, CementedDistribution: U.S: FL and TX
O.U.S.: N/ARecall #Z-0744-2025
Open, ClassifiedPosted Dec 19, 2024·Initiated Nov 1, 2024
Becker External Drainage and Monitoring System:
24146 EDMS 24146 BECKER NO Y-SITE
25120 EDMS II 25120 BECKER W/1-WAY VALVE
26040 KIT 26040 BECKER EDMS II
27609 BECKER 27609 W/NEEDLESLESS INJ. SITE
27670 BECKER 27670 STOP BELOW DC NDL-LS IN
27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN
27702 EDMS 27702 EURO BECKER II GR PT LN
27761 BECKER 27761 STOP BCNDLESS PATLN 24
27767 BECKER 27767 NO STPCOCK ON PTLN 63
27779 EDMS 27779 BECKER BC NDLESS BOND CONN
27811 EDMS 27811 BECKER GRN PL VCATH
27931 EDMS 27931 BECKER GS TUBING SMARTSITES
46128 EDMS 46128 BECKER II BLUE PT LN
46129 EDMS 46129 EURO BECKER II BLUE PT LN
The Becker External Drainage and Monitoring System (Becker EDMS) is a closed system for:
1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space.
2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
Reason: Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Root cause: Under Investigation by firm
Recalling firm: Medtronic NeurosurgeryType: Device, Monitoring, Intracranial PressureDistribution: Worldwide distribution. US nationwide including Puerto Rico; Algeria, Argentina, Australia, Austria, Bahrain, Barbados, Bosnia And Herzegovina, Brunei Darussalam, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, French Guiana, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Honduras, Hong Kong, Iceland, Indonesia, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Lao People s Democratic Republic, Latvia, Lebanon, Libya, Malaysia, Malta, Mauritania, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Republic of Tanzania, Thailand, Trinidad And Tobago, Tunisia, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.Recall #Z-0661-2025