Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG PAT XRAY 1X3
Model/Catalog Number: 801408. 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-0246-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG PAT XRAY 3X3
Model/Catalog Number: 801409.
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-0247-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG STRP 1/8X6
Model/Catalog Number: 801449. 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-0248-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG STRP 1/4X6
Model/Catalog Number: 801450.
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-0249-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG STRP 1/2X6
Model/Catalog Number: 801451.
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-0250-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG STRP 3/4X6
Model/Catalog Number: 801452. 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-0251-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG STRP 1X6-200
Model/Catalog Number: 801453. 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-0252-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG STRP 1-1/2X6
Model/Catalog Number: 801454.
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-0253-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG STRP 2X6
Model/Catalog Number: 801455. 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-0254-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG STRP 3X6
Model/Catalog Number: 801456. 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-0255-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 20, 2024
SURG STRP 3-1/2X6
Model/Catalog Number:801457. 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-0256-2025
Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 19, 2024
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)
Reason: Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
Root cause: Under Investigation by firm
Recalling firm: Covidien LPType: Catheter, Angioplasty, Peripheral, TransluminalDistribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Canada, Canary Islands, China, France, French Guiana, Germany, Greece, Guadeloupe, India, Ireland, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Spain and Turkey.Recall #Z-0257-2025 Open, ClassifiedPosted Oct 29, 2024·Initiated Sep 13, 2024
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma
Model/Catalog Number: EIA-1292
Reason: The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.
Root cause: Process change control
Recalling firm: DRG International, Inc.Type: Radioimmunoassay, 17-HydroxyprogesteroneDistribution: AZ, CA, NH
Foreign:
Austria
Belgium
Georgia
Germany
Greece
India
Irak
Italy
Netherlands
Poland
Romania
Russia
Singapore
Spain
Tunesia
VietnamRecall #Z-0258-2025
Open, ClassifiedPosted Oct 25, 2024·Initiated Sep 20, 2024
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
Reason: There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
Root cause: Device Design
Recalling firm: Maquet Cardiovascular, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide distribution. US Nationwide. Brazil, China, and Hong Kong.Recall #Z-0092-2025
Open, ClassifiedPosted Oct 25, 2024·Initiated Sep 13, 2024
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
Model/Catalog Number: BD-410X-1055
Reason: Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Stents, Drains And Dilators For The Biliary DuctsDistribution: Worldwide Distribution: US distribution to states of: CA, FL, IL, NJ, NY, PA, TN, VA, WI; and Foreign OUS to countries of: CA, DE, IN, SG, Latin America.Recall #Z-0225-2025
Open, ClassifiedPosted Oct 25, 2024·Initiated Sep 6, 2024
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Reason: Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)Distribution: Nationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY, OH, Puerto Rico, SC, UT, VA, WA.Recall #Z-0226-2025 Open, ClassifiedPosted Oct 25, 2024·Initiated Sep 18, 2024
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B100026, P7900B100222, P7900B100281, P7900B1SPL05, P7900B000011, P7900B100018, P7900B100028, P7900B100223, P7900B100287, P7900B1SPL06, P7900B000020, P7900B100019, P7900B100039, P7900B100224, P7900B100288, P7900B000022, P7900B100020, P7900B100090, P7900B100231, P7900B100292, P7900B100001, P7900B100021, P7900B100161, P7900B100237, P7900B100293, P7900B100005, P7900B100022, P7900B100203, P7900B100242, P7900B100294, P7900B100009, P7900B100023, P7900B100205, P7900B100264, and P7900B100296.
b. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900A000001, P7900A000010, P7900A000019, P7900A000039, P7900A000005, P7900A000011, P7900A000022, and P7900A000063.
Reason: The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system.
Root cause: Software design
Recalling firm: Baxter Healthcare CorporationType: Bed, Ac-Powered Adjustable HospitalDistribution: Worldwide distribution - US Nationwide. There was government and military distribution. The countries of Canada and Australia.Recall #Z-0228-2025
Open, ClassifiedPosted Oct 25, 2024·Initiated Aug 23, 2024
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Reason: During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
Root cause: Equipment maintenance
Recalling firm: Olympus Corporation of the AmericasType: Pump, Air, Non-Manual, For EndoscopeDistribution: US Nationwide distribution.Recall #Z-0229-2025
Open, ClassifiedPosted Oct 25, 2024·Initiated Aug 30, 2024
LIFEPAK 15 (LP15) Model/Catalog Numbers:
o 97577-000101
o 99577-000046
o 99577-000055
o 99577-000061
o 99577-000076
o 99577-001250
o 99577-001255
o 99577-001256
o 99577-001368
o 99577-001955
o 99577-001956
o 99577-001957
o 99577-001958
o 99577-001962
LIFEPAK 15 intended use monitor/defibrillator.
Reason: Due to an out of tolerance tool being used on monitor/defibrillator systems.
Root cause: Vendor change control
Recalling firm: Physio-Control, Inc.Type: Automated External Defibrillators (Non-Wearable)Distribution: U.S.: CT, GA, MA, NY, OH, WA, and WV.
O.U.S.: N/ARecall #Z-0230-2025 Open, ClassifiedPosted Oct 25, 2024·Initiated Sep 16, 2024
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms.
Model/Catalog Number: CLT-010, CLT-010-1
Reason: Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.
Root cause: Process control
Recalling firm: ImaCor Inc.Type: Transducer, Ultrasonic, DiagnosticDistribution: FL ,GA, NJ, TNRecall #Z-0231-2025