Open, ClassifiedPosted Sep 30, 2024·Initiated Oct 4, 2023
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Reason: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Root cause: Device Design
Recalling firm: Philips North AmericaType: Interventional Fluoroscopic X-Ray SystemDistribution: United States
Territories of Puerto Rico, Guam, and Virgin IslandsRecall #Z-0224-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Oct 4, 2023
Zenition 50 & 70 Mobile Surgery C-arm
Reason: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Root cause: Device Design
Recalling firm: Philips North AmericaType: Interventional Fluoroscopic X-Ray SystemDistribution: United States
Territories of Puerto Rico, Guam, and Virgin IslandsRecall #Z-0226-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Oct 4, 2023
Integris-Allura IGTS Fixed Systems
Reason: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Root cause: Device Design
Recalling firm: Philips North AmericaType: Interventional Fluoroscopic X-Ray SystemDistribution: United States
Territories of Puerto Rico, Guam, and Virgin IslandsRecall #Z-0227-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Oct 4, 2023
Allura Xper IGTS Fixed Systems
Reason: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Root cause: Device Design
Recalling firm: Philips North AmericaType: Interventional Fluoroscopic X-Ray SystemDistribution: United States
Territories of Puerto Rico, Guam, and Virgin IslandsRecall #Z-0228-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Oct 4, 2023
Azurion IGTS Fixed Systems
Reason: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Root cause: Device Design
Recalling firm: Philips North AmericaType: Interventional Fluoroscopic X-Ray SystemDistribution: United States
Territories of Puerto Rico, Guam, and Virgin IslandsRecall #Z-0229-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Oct 4, 2023
Veradius Unity Mobile Surgery C-arm
Reason: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Root cause: Device Design
Recalling firm: Philips North AmericaType: Interventional Fluoroscopic X-Ray SystemDistribution: United States
Territories of Puerto Rico, Guam, and Virgin IslandsRecall #Z-0230-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Oct 19, 2023
Medline Leg bag, REF DYND12574
Reason: Undeclared latex
Root cause: Labeling mix-ups
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Bag, Urine Collection, Leg, For External Use, SterileDistribution: US and PanamaRecall #Z-0533-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Oct 19, 2023
Medline Leg bag, REF DYND12578
Reason: Undeclared latex
Root cause: Labeling mix-ups
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Bag, Urine Collection, Leg, For External Use, SterileDistribution: US and PanamaRecall #Z-0534-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Oct 19, 2023
Medline Leg bag, REF URO12573
Reason: Undeclared latex
Root cause: Labeling mix-ups
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Bag, Urine Collection, Leg, For External Use, SterileDistribution: US and PanamaRecall #Z-0535-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Nov 14, 2023
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours).
Product REF Numbers:
701072780; 701048012
Reason: CARDIOHELP-i System was not properly tested to measure leakage current
Root cause: Process design
Recalling firm: Maquet Medical Systems USAType: Console, Heart-Lung Machine, Cardiopulmonary BypassDistribution: Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iran, Islamic Republic Of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Macao, Maldives, Martinique, Mayotte, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom,Vietnam, YemenRecall #Z-0595-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Nov 22, 2023
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Reason: Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
Root cause: Device Design
Recalling firm: DeRoyal Industries IncType: General Surgery TrayDistribution: US: VirginiaRecall #Z-0622-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Jan 4, 2024
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Reason: Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Syringe, Irrigating (Non Dental)Distribution: US, NationwideRecall #Z-1157-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Jan 17, 2024
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Reason: The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Root cause: Labeling Change Control
Recalling firm: ConvaTec, IncType: Bag, Drainage, With Adhesive, OstomyDistribution: Distribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX. There was government distribution but no military distribution.
Foreign distribution was made to Canada.Recall #Z-1276-2024
Open, ClassifiedPosted Sep 30, 2024·Initiated Feb 1, 2023
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum
Catalogue number: CP3826
Reason: The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
Root cause: Under Investigation by firm
Recalling firm: Randox LaboratoriesType: C-Reactive Protein, Antigen, Antiserum, And ControlDistribution: PA, OH, WVRecall #Z-1286-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Feb 3, 2023
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.
Part Number: 0000880311
Reason: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Root cause: Device Design
Recalling firm: Instrumentation LaboratoryType: Assay, HeparinDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria,
Australia, Austria, Azerbaijan, Belarus, Belgium, Brazil, Bulgaria, Cape Verde, China,
Colombia, Czech Republic, Egypt, Falkland Islands, Finland, France, Georgia, Germany,
Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan,
Kazakhstan, Kenya, Kossovo, Latvia, Lebanon, Lithuania, Malawi, Malaysia, Mexico,
Philippines, Poland, Romania, Russian Fed., Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom,
Uruguay, Utd.Arab Emir., Vietnam, Zimbabwe.Recall #Z-1304-2023 Open, ClassifiedPosted Sep 30, 2024·Initiated Feb 3, 2023
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.
Part Number: 0001000311
Reason: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Root cause: Device Design
Recalling firm: Instrumentation LaboratoryType: Assay, HeparinDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria,
Australia, Austria, Azerbaijan, Belarus, Belgium, Brazil, Bulgaria, Cape Verde, China,
Colombia, Czech Republic, Egypt, Falkland Islands, Finland, France, Georgia, Germany,
Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan,
Kazakhstan, Kenya, Kossovo, Latvia, Lebanon, Lithuania, Malawi, Malaysia, Mexico,
Philippines, Poland, Romania, Russian Fed., Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom,
Uruguay, Utd.Arab Emir., Vietnam, Zimbabwe.Recall #Z-1305-2023 Open, ClassifiedPosted Sep 30, 2024·Initiated Feb 3, 2023
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.
Part Number: 0000880311R
Reason: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Root cause: Device Design
Recalling firm: Instrumentation LaboratoryType: Assay, HeparinDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria,
Australia, Austria, Azerbaijan, Belarus, Belgium, Brazil, Bulgaria, Cape Verde, China,
Colombia, Czech Republic, Egypt, Falkland Islands, Finland, France, Georgia, Germany,
Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan,
Kazakhstan, Kenya, Kossovo, Latvia, Lebanon, Lithuania, Malawi, Malaysia, Mexico,
Philippines, Poland, Romania, Russian Fed., Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom,
Uruguay, Utd.Arab Emir., Vietnam, Zimbabwe.Recall #Z-1306-2023 Open, ClassifiedPosted Sep 30, 2024·Initiated Feb 3, 2023
ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.
Part Number: 0001000311R
Reason: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Root cause: Device Design
Recalling firm: Instrumentation LaboratoryType: Assay, HeparinDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria,
Australia, Austria, Azerbaijan, Belarus, Belgium, Brazil, Bulgaria, Cape Verde, China,
Colombia, Czech Republic, Egypt, Falkland Islands, Finland, France, Georgia, Germany,
Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan,
Kazakhstan, Kenya, Kossovo, Latvia, Lebanon, Lithuania, Malawi, Malaysia, Mexico,
Philippines, Poland, Romania, Russian Fed., Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom,
Uruguay, Utd.Arab Emir., Vietnam, Zimbabwe.Recall #Z-1307-2023 Open, ClassifiedPosted Sep 30, 2024·Initiated Mar 21, 2023
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6.
Models/Model Number:
(1) Azurion 3M12: 722063, 722221;
(2) Azurion 3M15: 722064, 722222;
(3) Azurion SM12: 722227;
(4) Azurion SM20: 722228;
(5) Azurion 7B12/12: 722067, 722225;
(6) Azurion 7820/15: 722068, 722226;
(7) Azurion 7M12: 722078, 722223;
(8) Azurion 7M20 : 722079, 722224
Reason: Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available
there will be a sudden interruption of the procedure
Root cause: Under Investigation by firm
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Nationwide
Foreign:
Algeria
Argentina
Armenia
Australia
Austria
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Brazil
Bulgaria
Cambodia
Chile
China
Colombia
Costa Rica
C¿te D'Ivoire
Croatia
Cyprus
Czech Republic
Denmark
Dominican Rep
Ecuador
Egypt
Estonia
Finland
France
French Polynesia
Germany
Greece
Hong Kong
Hungary
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kazakhstan
Kenya
Korea, Republic of
Kosovo
Kuwait
Latvia
Lebanon
Lithuania
Macao
Macedonia
Malaysia
Mexico
Morocco
Myanmar
Nepal
Netherlands
New Zealand
Nicaragua
Nigeria
Norway
Oman
Pakistan
Palestine
Palestine, State of
Panama
Peru
Philippines
Poland
Portugal
Puerto Rico
Qatar
Romania
Russian Federation
Saudi Arabia
Senegal
Serbia
Singapore
Slovakia
Slovenia
South Africa
South Korea
Spain
Sri Lanka
Sweden
Switzerland
Taiwan
Thailand
Tunisia
Turkey
Turkmenistan
Ukraine
United Kingdom
Utd.Arab.Emir.
Uzbekistan
Vietnam
YemenRecall #Z-1647-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm.
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Mesh, SurgicalDistribution: Domestic: Nationwide Distribution.Recall #Z-2069-2023