Open, ClassifiedPosted Oct 30, 2024·Initiated Sep 26, 2024
KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway.
Model/Catalog Number: KLTSD4225
Reason: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Root cause: No Marketing Application
Recalling firm: King Systems Corp. dba Ambu, Inc.Type: Airway, Oropharyngeal, AnesthesiologyDistribution: NationwideRecall #Z-0272-2025
Open, ClassifiedPosted Oct 30, 2024·Initiated Sep 26, 2024
KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway.
Model/Catalog Number: KLTSD430
Reason: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Root cause: No Marketing Application
Recalling firm: King Systems Corp. dba Ambu, Inc.Type: Airway, Oropharyngeal, AnesthesiologyDistribution: NationwideRecall #Z-0273-2025
Open, ClassifiedPosted Oct 30, 2024·Initiated Sep 26, 2024
KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431
Reason: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Root cause: No Marketing Application
Recalling firm: King Systems Corp. dba Ambu, Inc.Type: Airway, Oropharyngeal, AnesthesiologyDistribution: NationwideRecall #Z-0274-2025
Open, ClassifiedPosted Oct 30, 2024·Initiated Sep 26, 2024
KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway.
Model/Catalog Number: KLTSD432
Reason: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Root cause: No Marketing Application
Recalling firm: King Systems Corp. dba Ambu, Inc.Type: Airway, Oropharyngeal, AnesthesiologyDistribution: NationwideRecall #Z-0275-2025
Open, ClassifiedPosted Oct 30, 2024·Initiated Sep 26, 2024
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway.
Model/Catalog Number: KKLTSD4325
Reason: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Root cause: No Marketing Application
Recalling firm: King Systems Corp. dba Ambu, Inc.Type: Airway, Oropharyngeal, AnesthesiologyDistribution: NationwideRecall #Z-0276-2025
Open, ClassifiedPosted Oct 30, 2024·Initiated Oct 2, 2024
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Reason: Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Root cause: Packaging change control
Recalling firm: Smith & Nephew IncType: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.Recall #Z-0277-2025
Open, ClassifiedPosted Oct 30, 2024·Initiated Oct 2, 2024
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Reason: Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Root cause: Packaging change control
Recalling firm: Smith & Nephew IncType: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.Recall #Z-0278-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 12, 2024
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
Reason: Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
Root cause: Device Design
Recalling firm: Abbott Molecular, Inc.Type: Kit, Dna Detection, Human PapillomavirusDistribution: Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) countries of: AUSTRIA, BELGUIM, BULGARIA, CAMBODIA, CANADA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, KAZAKHSTAN, KENYA, LUXEMBOURG, MALAWI, MALAYSIA, MONTENEGRO, MOROCCO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TANZANIA, THAILAND, UNITED KINGDOM, AND VIETNAM.Recall #Z-0233-2025 Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 12, 2024
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
Reason: Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
Root cause: Device Design
Recalling firm: Abbott Molecular, Inc.Type: Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsDistribution: Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) countries of: AUSTRIA, BELGUIM, BULGARIA, CAMBODIA, CANADA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, KAZAKHSTAN, KENYA, LUXEMBOURG, MALAWI, MALAYSIA, MONTENEGRO, MOROCCO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TANZANIA, THAILAND, UNITED KINGDOM, AND VIETNAM.Recall #Z-0234-2025 Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
MICR PATIE RND
Model/Catalog Number: 801396.
CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Root cause: Nonconforming Material/Component
Recalling firm: Integra LifeSciences Corp.Type: Neurosurgical PaddieDistribution: Worldwide Distribution. US Nationwide,
Canada
Germany
United Kingdom of Great Britain and Northern Ireland (the)
Malta
Italy
Barbados
Trinidad and Tobago
Australia
New Zealand
Netherlands (the)
Belgium
France
Ireland
Switzerland
Brunei Darussalam
Bahamas (the)
South Africa
China
Ecuador
Korea (the Republic of)
Czechia
Kuwait
Luxembourg
French Guiana
Mayotte
Burundi
Reunion
Martinique
Poland
Costa Rica
Japan
Senegal
Turkey
Serbia
Mexico
Cambodia
Spain
Ghana
Iceland
Jersey
Iraq
Bahrain
Lebanon
Dominican Republic (the)
Singapore
Portugal
Greece
Austria
C¿te d'Ivoire
Palestine, State of
Georgia
Nigeria
Slovenia
Sweden
Colombia
United Arab Emirates (the)
Saudi Arabia
Qatar
Hong Kong
Oman
Albania
Panama
Holy See (the)
Kenya
Pakistan
Guernsey
Morocco
Chile
Brazil
Argentina
Puerto Rico
Rwanda
Jordan
Philippines (the)
Hungary
Romania
Bolivia (Plurinational State of)
Malaysia
El Salvador
Peru
Lithuania
Republic of North Macedonia
Taiwan (Province of China)
Israel
Cyprus
BulgariaRecall #Z-0235-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG PAT XRAY 1/4X1-1/2
Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Root cause: Nonconforming Material/Component
Recalling firm: Integra LifeSciences Corp.Type: Neurosurgical PaddieDistribution: Worldwide Distribution. US Nationwide,
Canada
Germany
United Kingdom of Great Britain and Northern Ireland (the)
Malta
Italy
Barbados
Trinidad and Tobago
Australia
New Zealand
Netherlands (the)
Belgium
France
Ireland
Switzerland
Brunei Darussalam
Bahamas (the)
South Africa
China
Ecuador
Korea (the Republic of)
Czechia
Kuwait
Luxembourg
French Guiana
Mayotte
Burundi
Reunion
Martinique
Poland
Costa Rica
Japan
Senegal
Turkey
Serbia
Mexico
Cambodia
Spain
Ghana
Iceland
Jersey
Iraq
Bahrain
Lebanon
Dominican Republic (the)
Singapore
Portugal
Greece
Austria
C¿te d'Ivoire
Palestine, State of
Georgia
Nigeria
Slovenia
Sweden
Colombia
United Arab Emirates (the)
Saudi Arabia
Qatar
Hong Kong
Oman
Albania
Panama
Holy See (the)
Kenya
Pakistan
Guernsey
Morocco
Chile
Brazil
Argentina
Puerto Rico
Rwanda
Jordan
Philippines (the)
Hungary
Romania
Bolivia (Plurinational State of)
Malaysia
El Salvador
Peru
Lithuania
Republic of North Macedonia
Taiwan (Province of China)
Israel
Cyprus
BulgariaRecall #Z-0236-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG PAT XRAY 1/4X3
Model/Catalog Number: 801398.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Root cause: Nonconforming Material/Component
Recalling firm: Integra LifeSciences Corp.Type: Neurosurgical PaddieDistribution: Worldwide Distribution. US Nationwide,
Canada
Germany
United Kingdom of Great Britain and Northern Ireland (the)
Malta
Italy
Barbados
Trinidad and Tobago
Australia
New Zealand
Netherlands (the)
Belgium
France
Ireland
Switzerland
Brunei Darussalam
Bahamas (the)
South Africa
China
Ecuador
Korea (the Republic of)
Czechia
Kuwait
Luxembourg
French Guiana
Mayotte
Burundi
Reunion
Martinique
Poland
Costa Rica
Japan
Senegal
Turkey
Serbia
Mexico
Cambodia
Spain
Ghana
Iceland
Jersey
Iraq
Bahrain
Lebanon
Dominican Republic (the)
Singapore
Portugal
Greece
Austria
C¿te d'Ivoire
Palestine, State of
Georgia
Nigeria
Slovenia
Sweden
Colombia
United Arab Emirates (the)
Saudi Arabia
Qatar
Hong Kong
Oman
Albania
Panama
Holy See (the)
Kenya
Pakistan
Guernsey
Morocco
Chile
Brazil
Argentina
Puerto Rico
Rwanda
Jordan
Philippines (the)
Hungary
Romania
Bolivia (Plurinational State of)
Malaysia
El Salvador
Peru
Lithuania
Republic of North Macedonia
Taiwan (Province of China)
Israel
Cyprus
BulgariaRecall #Z-0237-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG PAT XRAY 1/4X1/4
Model/Catalog Number: 801399.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Root cause: Nonconforming Material/Component
Recalling firm: Integra LifeSciences Corp.Type: Neurosurgical PaddieDistribution: Worldwide Distribution. US Nationwide,
Canada
Germany
United Kingdom of Great Britain and Northern Ireland (the)
Malta
Italy
Barbados
Trinidad and Tobago
Australia
New Zealand
Netherlands (the)
Belgium
France
Ireland
Switzerland
Brunei Darussalam
Bahamas (the)
South Africa
China
Ecuador
Korea (the Republic of)
Czechia
Kuwait
Luxembourg
French Guiana
Mayotte
Burundi
Reunion
Martinique
Poland
Costa Rica
Japan
Senegal
Turkey
Serbia
Mexico
Cambodia
Spain
Ghana
Iceland
Jersey
Iraq
Bahrain
Lebanon
Dominican Republic (the)
Singapore
Portugal
Greece
Austria
C¿te d'Ivoire
Palestine, State of
Georgia
Nigeria
Slovenia
Sweden
Colombia
United Arab Emirates (the)
Saudi Arabia
Qatar
Hong Kong
Oman
Albania
Panama
Holy See (the)
Kenya
Pakistan
Guernsey
Morocco
Chile
Brazil
Argentina
Puerto Rico
Rwanda
Jordan
Philippines (the)
Hungary
Romania
Bolivia (Plurinational State of)
Malaysia
El Salvador
Peru
Lithuania
Republic of North Macedonia
Taiwan (Province of China)
Israel
Cyprus
BulgariaRecall #Z-0238-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG PAT XRAY 1/2X1/2
Model/Catalog Number: 801400.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Root cause: Nonconforming Material/Component
Recalling firm: Integra LifeSciences Corp.Type: Neurosurgical PaddieDistribution: Worldwide Distribution. US Nationwide,
Canada
Germany
United Kingdom of Great Britain and Northern Ireland (the)
Malta
Italy
Barbados
Trinidad and Tobago
Australia
New Zealand
Netherlands (the)
Belgium
France
Ireland
Switzerland
Brunei Darussalam
Bahamas (the)
South Africa
China
Ecuador
Korea (the Republic of)
Czechia
Kuwait
Luxembourg
French Guiana
Mayotte
Burundi
Reunion
Martinique
Poland
Costa Rica
Japan
Senegal
Turkey
Serbia
Mexico
Cambodia
Spain
Ghana
Iceland
Jersey
Iraq
Bahrain
Lebanon
Dominican Republic (the)
Singapore
Portugal
Greece
Austria
C¿te d'Ivoire
Palestine, State of
Georgia
Nigeria
Slovenia
Sweden
Colombia
United Arab Emirates (the)
Saudi Arabia
Qatar
Hong Kong
Oman
Albania
Panama
Holy See (the)
Kenya
Pakistan
Guernsey
Morocco
Chile
Brazil
Argentina
Puerto Rico
Rwanda
Jordan
Philippines (the)
Hungary
Romania
Bolivia (Plurinational State of)
Malaysia
El Salvador
Peru
Lithuania
Republic of North Macedonia
Taiwan (Province of China)
Israel
Cyprus
BulgariaRecall #Z-0239-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG PAT XRAY 3/4X3/4
Model/Catalog Number: 801401.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Root cause: Nonconforming Material/Component
Recalling firm: Integra LifeSciences Corp.Type: Neurosurgical PaddieDistribution: Worldwide Distribution. US Nationwide,
Canada
Germany
United Kingdom of Great Britain and Northern Ireland (the)
Malta
Italy
Barbados
Trinidad and Tobago
Australia
New Zealand
Netherlands (the)
Belgium
France
Ireland
Switzerland
Brunei Darussalam
Bahamas (the)
South Africa
China
Ecuador
Korea (the Republic of)
Czechia
Kuwait
Luxembourg
French Guiana
Mayotte
Burundi
Reunion
Martinique
Poland
Costa Rica
Japan
Senegal
Turkey
Serbia
Mexico
Cambodia
Spain
Ghana
Iceland
Jersey
Iraq
Bahrain
Lebanon
Dominican Republic (the)
Singapore
Portugal
Greece
Austria
C¿te d'Ivoire
Palestine, State of
Georgia
Nigeria
Slovenia
Sweden
Colombia
United Arab Emirates (the)
Saudi Arabia
Qatar
Hong Kong
Oman
Albania
Panama
Holy See (the)
Kenya
Pakistan
Guernsey
Morocco
Chile
Brazil
Argentina
Puerto Rico
Rwanda
Jordan
Philippines (the)
Hungary
Romania
Bolivia (Plurinational State of)
Malaysia
El Salvador
Peru
Lithuania
Republic of North Macedonia
Taiwan (Province of China)
Israel
Cyprus
BulgariaRecall #Z-0240-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG PAT XRAY 1/2X1
Model/Catalog Number: 801402.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Root cause: Nonconforming Material/Component
Recalling firm: Integra LifeSciences Corp.Type: Neurosurgical PaddieDistribution: Worldwide Distribution. US Nationwide,
Canada
Germany
United Kingdom of Great Britain and Northern Ireland (the)
Malta
Italy
Barbados
Trinidad and Tobago
Australia
New Zealand
Netherlands (the)
Belgium
France
Ireland
Switzerland
Brunei Darussalam
Bahamas (the)
South Africa
China
Ecuador
Korea (the Republic of)
Czechia
Kuwait
Luxembourg
French Guiana
Mayotte
Burundi
Reunion
Martinique
Poland
Costa Rica
Japan
Senegal
Turkey
Serbia
Mexico
Cambodia
Spain
Ghana
Iceland
Jersey
Iraq
Bahrain
Lebanon
Dominican Republic (the)
Singapore
Portugal
Greece
Austria
C¿te d'Ivoire
Palestine, State of
Georgia
Nigeria
Slovenia
Sweden
Colombia
United Arab Emirates (the)
Saudi Arabia
Qatar
Hong Kong
Oman
Albania
Panama
Holy See (the)
Kenya
Pakistan
Guernsey
Morocco
Chile
Brazil
Argentina
Puerto Rico
Rwanda
Jordan
Philippines (the)
Hungary
Romania
Bolivia (Plurinational State of)
Malaysia
El Salvador
Peru
Lithuania
Republic of North Macedonia
Taiwan (Province of China)
Israel
Cyprus
BulgariaRecall #Z-0241-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG PAT XRAY 1X1
Model/Catalog Number: 801403.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Root cause: Nonconforming Material/Component
Recalling firm: Integra LifeSciences Corp.Type: Neurosurgical PaddieDistribution: Worldwide Distribution. US Nationwide,
Canada
Germany
United Kingdom of Great Britain and Northern Ireland (the)
Malta
Italy
Barbados
Trinidad and Tobago
Australia
New Zealand
Netherlands (the)
Belgium
France
Ireland
Switzerland
Brunei Darussalam
Bahamas (the)
South Africa
China
Ecuador
Korea (the Republic of)
Czechia
Kuwait
Luxembourg
French Guiana
Mayotte
Burundi
Reunion
Martinique
Poland
Costa Rica
Japan
Senegal
Turkey
Serbia
Mexico
Cambodia
Spain
Ghana
Iceland
Jersey
Iraq
Bahrain
Lebanon
Dominican Republic (the)
Singapore
Portugal
Greece
Austria
C¿te d'Ivoire
Palestine, State of
Georgia
Nigeria
Slovenia
Sweden
Colombia
United Arab Emirates (the)
Saudi Arabia
Qatar
Hong Kong
Oman
Albania
Panama
Holy See (the)
Kenya
Pakistan
Guernsey
Morocco
Chile
Brazil
Argentina
Puerto Rico
Rwanda
Jordan
Philippines (the)
Hungary
Romania
Bolivia (Plurinational State of)
Malaysia
El Salvador
Peru
Lithuania
Republic of North Macedonia
Taiwan (Province of China)
Israel
Cyprus
BulgariaRecall #Z-0242-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG PAT XRAY 1/2X1-1/2
Model/Catalog Number: 801404.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Root cause: Nonconforming Material/Component
Recalling firm: Integra LifeSciences Corp.Type: Neurosurgical PaddieDistribution: Worldwide Distribution. US Nationwide,
Canada
Germany
United Kingdom of Great Britain and Northern Ireland (the)
Malta
Italy
Barbados
Trinidad and Tobago
Australia
New Zealand
Netherlands (the)
Belgium
France
Ireland
Switzerland
Brunei Darussalam
Bahamas (the)
South Africa
China
Ecuador
Korea (the Republic of)
Czechia
Kuwait
Luxembourg
French Guiana
Mayotte
Burundi
Reunion
Martinique
Poland
Costa Rica
Japan
Senegal
Turkey
Serbia
Mexico
Cambodia
Spain
Ghana
Iceland
Jersey
Iraq
Bahrain
Lebanon
Dominican Republic (the)
Singapore
Portugal
Greece
Austria
C¿te d'Ivoire
Palestine, State of
Georgia
Nigeria
Slovenia
Sweden
Colombia
United Arab Emirates (the)
Saudi Arabia
Qatar
Hong Kong
Oman
Albania
Panama
Holy See (the)
Kenya
Pakistan
Guernsey
Morocco
Chile
Brazil
Argentina
Puerto Rico
Rwanda
Jordan
Philippines (the)
Hungary
Romania
Bolivia (Plurinational State of)
Malaysia
El Salvador
Peru
Lithuania
Republic of North Macedonia
Taiwan (Province of China)
Israel
Cyprus
BulgariaRecall #Z-0243-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG PAT XRAY 1/2X2
Model/Catalog Number: 801406.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Root cause: Nonconforming Material/Component
Recalling firm: Integra LifeSciences Corp.Type: Neurosurgical PaddieDistribution: Worldwide Distribution. US Nationwide,
Canada
Germany
United Kingdom of Great Britain and Northern Ireland (the)
Malta
Italy
Barbados
Trinidad and Tobago
Australia
New Zealand
Netherlands (the)
Belgium
France
Ireland
Switzerland
Brunei Darussalam
Bahamas (the)
South Africa
China
Ecuador
Korea (the Republic of)
Czechia
Kuwait
Luxembourg
French Guiana
Mayotte
Burundi
Reunion
Martinique
Poland
Costa Rica
Japan
Senegal
Turkey
Serbia
Mexico
Cambodia
Spain
Ghana
Iceland
Jersey
Iraq
Bahrain
Lebanon
Dominican Republic (the)
Singapore
Portugal
Greece
Austria
C¿te d'Ivoire
Palestine, State of
Georgia
Nigeria
Slovenia
Sweden
Colombia
United Arab Emirates (the)
Saudi Arabia
Qatar
Hong Kong
Oman
Albania
Panama
Holy See (the)
Kenya
Pakistan
Guernsey
Morocco
Chile
Brazil
Argentina
Puerto Rico
Rwanda
Jordan
Philippines (the)
Hungary
Romania
Bolivia (Plurinational State of)
Malaysia
El Salvador
Peru
Lithuania
Republic of North Macedonia
Taiwan (Province of China)
Israel
Cyprus
BulgariaRecall #Z-0244-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG PAT XRAY 1/2X3
Model/Catalog Number: 801407.
The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Reason: Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Root cause: Nonconforming Material/Component
Recalling firm: Integra LifeSciences Corp.Type: Neurosurgical PaddieDistribution: Worldwide Distribution. US Nationwide,
Canada
Germany
United Kingdom of Great Britain and Northern Ireland (the)
Malta
Italy
Barbados
Trinidad and Tobago
Australia
New Zealand
Netherlands (the)
Belgium
France
Ireland
Switzerland
Brunei Darussalam
Bahamas (the)
South Africa
China
Ecuador
Korea (the Republic of)
Czechia
Kuwait
Luxembourg
French Guiana
Mayotte
Burundi
Reunion
Martinique
Poland
Costa Rica
Japan
Senegal
Turkey
Serbia
Mexico
Cambodia
Spain
Ghana
Iceland
Jersey
Iraq
Bahrain
Lebanon
Dominican Republic (the)
Singapore
Portugal
Greece
Austria
C¿te d'Ivoire
Palestine, State of
Georgia
Nigeria
Slovenia
Sweden
Colombia
United Arab Emirates (the)
Saudi Arabia
Qatar
Hong Kong
Oman
Albania
Panama
Holy See (the)
Kenya
Pakistan
Guernsey
Morocco
Chile
Brazil
Argentina
Puerto Rico
Rwanda
Jordan
Philippines (the)
Hungary
Romania
Bolivia (Plurinational State of)
Malaysia
El Salvador
Peru
Lithuania
Republic of North Macedonia
Taiwan (Province of China)
Israel
Cyprus
BulgariaRecall #Z-0245-2025