Open, ClassifiedPosted Dec 18, 2025·Initiated Oct 30, 2025
Brand Name: Xpert BCR-ABL Ultra
Model/Catalog Number: GXBCRABL-US-10
Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Root cause: Process design
Recalling firm: CepheidType: Bcr/Abl1 Monitoring TestDistribution: US: AL AR AZ CA CO FL GA IA IL KS KY LA MD ME MI MN MO NC NE NH NJ NY OH PA RI TX VA WA WI
OUS: Algeria Armenia Australia Austria Bahrain Bangladesh Belgium Brazil Burkina Faso Cambodia Canada Canary islands Chile Colombia Cyprus Czech Republic Dem. Rep. Congo Djibouti Dominican Rep. Ecuador El Salvador Eswatini Finland France Frenc.Polynesia Gambia Georgia Germany Ghana Greece Guadeloupe Guatemala Honduras Hong Kong India Indonesia Iraq Israel Italy Jamaica Jordan Kazakhstan Kenya Kuwait Latvia Lebanon Lithuania Luxembourg Malawi Malaysia Mauritania Mauritius Mexico Morocco Mozambique Myanmar Netherlands New Caledonia New Zealand Nicaragua Norway Oman Pap. New Guinea Peru Philippines Poland Portugal Qatar Rep.of Congo Reunion Rwanda Saudi Arabia Senegal Seychelles Singapore South Africa Spain Sri Lanka Sweden Switzerland Taiwan Tajikistan Tanzania Thailand Togo Tunisia Uganda United Kingdom Uruguay Utd.Arab Emir. Venezuela Zambia ZimbabweRecall #Z-0959-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Oct 30, 2025
Brand Name: Xpert BCR-ABL Ultra
Model/Catalog Number: GXBCRABL-10
Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Root cause: Process design
Recalling firm: CepheidType: Bcr/Abl1 Monitoring TestDistribution: US: AL AR AZ CA CO FL GA IA IL KS KY LA MD ME MI MN MO NC NE NH NJ NY OH PA RI TX VA WA WI
OUS: Algeria Armenia Australia Austria Bahrain Bangladesh Belgium Brazil Burkina Faso Cambodia Canada Canary islands Chile Colombia Cyprus Czech Republic Dem. Rep. Congo Djibouti Dominican Rep. Ecuador El Salvador Eswatini Finland France Frenc.Polynesia Gambia Georgia Germany Ghana Greece Guadeloupe Guatemala Honduras Hong Kong India Indonesia Iraq Israel Italy Jamaica Jordan Kazakhstan Kenya Kuwait Latvia Lebanon Lithuania Luxembourg Malawi Malaysia Mauritania Mauritius Mexico Morocco Mozambique Myanmar Netherlands New Caledonia New Zealand Nicaragua Norway Oman Pap. New Guinea Peru Philippines Poland Portugal Qatar Rep.of Congo Reunion Rwanda Saudi Arabia Senegal Seychelles Singapore South Africa Spain Sri Lanka Sweden Switzerland Taiwan Tajikistan Tanzania Thailand Togo Tunisia Uganda United Kingdom Uruguay Utd.Arab Emir. Venezuela Zambia ZimbabweRecall #Z-0960-2026
Open, ClassifiedPosted Dec 18, 2025·Initiated Nov 13, 2025
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Reason: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
Root cause: Software design
Recalling firm: Abbott LaboratoriesType: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR; and OUS (foreign) to countries of: Albania, Algeria, Andorra, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Finland, France, Gaza & Jericho, Georgia, Germany, Greece, Greenland, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malawi, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mexico, Moldova, Montenegro, Morocco, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Northern Ireland, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, Ukraine, United Kingdom, Uruguay, Vietnam and Zambia.
OUS: ALBANIA, ALGERIA, ANDORRA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CAMEROON, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FAROE ISLANDS, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GREECE, GREENLAND, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOSOVO, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAWI, MALAYSIA, MALDIVES, MALTA, MAURITANIA, MAURITIUS, MEXICO, MOLDOVA, MONTENEGRO, MOROCCO, NAMIBIA, NEPAL, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA (CIS), RWANDA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UGANDA, UKRAINE, UNITED KINGDOM, URUGUAY, VIETNAM, ZAMBIA Open, ClassifiedPosted Dec 17, 2025·Initiated Oct 25, 2025
5008X CAREsystem +CLiC +CDX;
Reason: Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Root cause: Software design
Recalling firm: Fresenius Medical Care Holdings, Inc.Type: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: Domestic: LA, MA, MN;Recall #Z-0936-2026
Open, ClassifiedPosted Dec 17, 2025·Initiated Nov 17, 2025
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments:
Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-400145; Navigation, 5.5mm Drill, REF: PC2-400155; Navigation, 3.5mm Tap, REF: PC2-400235; Navigation, 4.0mm Tap, REF: PC2-400240; Navigation, 4.5mm Tap, REF: PC2-400245; Navigation, 4.5mm Dual Lead Tap, REF: PC2-400345; Navigation, 5.5mm Dual Lead Tap, REF: PC2-400355
Reason: The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.
Root cause: Labeling design
Recalling firm: SEASPINE ORTHOPEDICS CORPORATIONType: Orthopedic Stereotaxic InstrumentDistribution: US: CT, TX, NV, CO, CA, WA, NJ, OR, IN, MI, FL, PA, IL, VA, AL, RI, MO, AZ, MS, SC, UT, NY, OK, SD.
OUS: Australia, Mexico, ChileRecall #Z-0937-2026
Open, ClassifiedPosted Dec 17, 2025·Initiated Nov 18, 2025
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Reason: Recalled lots were manufactured with double the amount of preservative concentration.
Root cause: Process control
Recalling firm: Instrumentation LaboratoryType: Activated Partial ThromboplastinDistribution: Domestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL, IN, IT, JP, LK, NL, PL, PT, RO, RS, TH, VN.Recall #Z-0938-2026 Open, ClassifiedPosted Dec 16, 2025·Initiated Nov 14, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Reason: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Root cause: Software design
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.Recall #Z-0885-2026
Open, ClassifiedPosted Dec 16, 2025·Initiated Oct 23, 2025
Cardiosave Hybrid
Reason: The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Root cause: Process change control
Recalling firm: Datascope Corp.Type: System, Balloon, Intra-Aortic And ControlDistribution: Domestic: Nationwide distribution.
International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Republic of, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, (Ivory Coast), Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, (Burma), Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic Of China, Tanzania, United Republic Of, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia;Recall #Z-0931-2026
Open, ClassifiedPosted Dec 16, 2025·Initiated Oct 23, 2025
Cardiosave Rescue
Reason: The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Root cause: Process change control
Recalling firm: Datascope Corp.Type: System, Balloon, Intra-Aortic And ControlDistribution: Domestic: Nationwide distribution.
International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Republic of, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, (Ivory Coast), Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, (Burma), Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic Of China, Tanzania, United Republic Of, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia;Recall #Z-0932-2026
Open, ClassifiedPosted Dec 16, 2025·Initiated Nov 3, 2025
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Reason: GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
Root cause: Device Design
Recalling firm: GE Healthcare GmbHType: System, Image Processing, RadiologicalDistribution: WorldwideRecall #Z-0935-2026
Open, ClassifiedPosted Dec 15, 2025·Initiated Nov 24, 2025
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Reason: The devices may have a misaligned thickness control bar.
Root cause: Process control
Recalling firm: Zimmer Surgical IncType: DermatomeDistribution: Distribution regions: USA, Hong Kong, Thailand, Japan, Korea, Australia, Taiwan, India, Malaysia, Singapore, China, Canada, EMEA, Mexico, Trinidad & Tobago, Panama, Guatemala
Refer to the attached ZFA 2025-00141_Initial Consignee List and ZFA 2025-001141_Initial Distribution History containing the distribution and the identification of the domestic consignees.Recall #Z-0924-2026
Open, ClassifiedPosted Dec 15, 2025·Initiated Nov 24, 2025
Zimmer Dermatome AN, Model/Catalog Number: 88710100
Reason: The devices may have a misaligned thickness control bar.
Root cause: Process control
Recalling firm: Zimmer Surgical IncType: DermatomeDistribution: Distribution regions: USA, Hong Kong, Thailand, Japan, Korea, Australia, Taiwan, India, Malaysia, Singapore, China, Canada, EMEA, Mexico, Trinidad & Tobago, Panama, Guatemala
Refer to the attached ZFA 2025-00141_Initial Consignee List and ZFA 2025-001141_Initial Distribution History containing the distribution and the identification of the domestic consignees.Recall #Z-0925-2026
Open, ClassifiedPosted Dec 15, 2025·Initiated Nov 14, 2025
Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
Reason: Potential for incomplete seal on header bag.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US distribution to GA, IL, NE, MD.Recall #Z-0926-2026
Open, ClassifiedPosted Dec 15, 2025·Initiated Nov 14, 2025
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Reason: Potential for incomplete seal on header bag.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US distribution to GA, IL, NE, MD.Recall #Z-0927-2026
Open, ClassifiedPosted Dec 15, 2025·Initiated Nov 14, 2025
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Reason: Potential for incomplete seal on header bag.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US distribution to GA, IL, NE, MD.Recall #Z-0928-2026
Open, ClassifiedPosted Dec 15, 2025·Initiated Nov 14, 2025
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
Reason: Potential for incomplete seal on header bag.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US distribution to GA, IL, NE, MD.Recall #Z-0929-2026
Open, ClassifiedPosted Dec 15, 2025·Initiated Nov 14, 2025
Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
Reason: Potential for incomplete seal on header bag.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US distribution to GA, IL, NE, MD.Recall #Z-0930-2026
Open, ClassifiedPosted Dec 12, 2025·Initiated Nov 18, 2025
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1
HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1)
Reason: When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
Root cause: Software design
Recalling firm: Mindray DS USA, Inc. dba Mindray North AmericaType: System, Network And Communication, Physiological MonitorsDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-0920-2026
Open, ClassifiedPosted Dec 12, 2025·Initiated Nov 13, 2025
SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
Reason: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
Root cause: Packaging process control
Recalling firm: Medline Industries, LPType: Scissors, General, SurgicalDistribution: US Nationwide distribution in the states CA, CO, IL, KS, and MI.Recall #Z-0921-2026
Open, ClassifiedPosted Dec 12, 2025·Initiated Nov 13, 2025
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
Reason: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
Root cause: Packaging process control
Recalling firm: Medline Industries, LPType: Scissors, General, SurgicalDistribution: US Nationwide distribution in the states CA, CO, IL, KS, and MI.Recall #Z-0922-2026