Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 1, 2026
i-STAT EG7+ cartridge;
List Number: 03P76-25;
Reason: Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
Root cause: Process change control
Recalling firm: Abbott Point Of Care Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.Recall #Z-1999-2026 Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 1, 2026
i-STAT EG6+ cartridge;
List Number: 03P77-25;
Reason: Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
Root cause: Process change control
Recalling firm: Abbott Point Of Care Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.Recall #Z-2000-2026 Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 1, 2026
i-STAT G3+ cartridge;
List Number: 03P78-26;
Reason: Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
Root cause: Process change control
Recalling firm: Abbott Point Of Care Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.Recall #Z-2001-2026 Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 2, 2026
Philips Bridge Prep Kit
REF: K12-09098B
Sterile EO, Rx ONLY
Reason: catheter may experience resistance when being advanced over the guidewire
Root cause: Nonconforming Material/Component
Recalling firm: Merit Medical Systems, Inc.Type: Angiography/Angioplasty KitDistribution: US Nationwide distribution in the state of CO.Recall #Z-2002-2026 Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 2, 2026
Philips Bridge Prep Kit
REF: K12-09098C
Sterile EO, Rx ONLY
Reason: catheter may experience resistance when being advanced over the guidewire
Root cause: Nonconforming Material/Component
Recalling firm: Merit Medical Systems, Inc.Type: Angiography/Angioplasty KitDistribution: US Nationwide distribution in the state of CO.Recall #Z-2003-2026 Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 2, 2026
Philips Bridge Prep Kit
REF: K12-09098C
Sterile EO, Rx ONLY
Reason: catheter may experience resistance when being advanced over the guidewire
Root cause: Nonconforming Material/Component
Recalling firm: Merit Medical Systems, Inc.Type: Angiography/Angioplasty KitDistribution: US Nationwide distribution in the state of CO.Recall #Z-2004-2026 Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 2, 2026
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System;
Siemens Material Number (SMN): 10736515;
Reason: Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics IncType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.Recall #Z-2005-2026 Open, ClassifiedPosted Apr 29, 2026·Initiated Mar 19, 2026
Brand Name: Leksell Vantage Arc System
REF: 1053958
Reason: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Root cause: Device Design
Recalling firm: Elekta, Inc.Type: Neurological Stereotaxic InstrumentDistribution: US: AR AZ CA CO DC FL GA ID IL KS MA MD ME MO MT NC NE NH NJ NM NV NY OH OK PA SC TX UT VA WA WI WV
OUS: Algeria Australia Austria Azerbaijan Belgium China Colombia Costa Rica Croatia Czech Republic Egypt Estonia Finland France Germany Greece Hong Kong Hungary India Israel Italy Japan Korea, Republic of Kuwait Lithuania Mexico Morocco Netherlands New Zealand Norway Pakistan Panama Poland Portugal Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United KingdomRecall #Z-2006-2026
Open, ClassifiedPosted Apr 28, 2026·Initiated Mar 18, 2026
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Reason: Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Alkaline Picrate, Colorimetry, CreatinineDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Brazil, Cambodia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, Germany, Honduras, India, Indonesia, Korea, Kuwait, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Paraguay, Philippines, Qatar, Saudi Arabia, Serbia, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, U.A.E., Ukraine, Uruguay, Vietnam, Yemen.Recall #Z-1980-2026 Open, ClassifiedPosted Apr 27, 2026·Initiated Mar 23, 2026
Brand Name: HiResolution" Bionic Ear System
Product Name: M Zn-Air Battery Pak
Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280
Software Version: Not Applicable
Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida" CI M and Sky CI" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery.
The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges.
Component: Not Applicable
Reason: The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.
Root cause: Under Investigation by firm
Recalling firm: Advanced Bionics, LLCType: Implant, CochlearDistribution: Worldwide - U.S Nationwide distribution including in the state of AK, AL, AR, AZ, CA, CO, CT, CD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Canada, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Chile, Croatia, Cuba, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, United Arab Emirates, and United Kingdom.Recall #Z-1950-2026 Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Achieva 1.5T with MR Elastography (MRE).
1. Model Number (REF): 781196.
2. Model Number (REF): 781296.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1951-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Achieva 1.5T Initial system with MR Elastography (MRE).
1. Model Number (REF): 781178.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1952-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Achieva 3.0T with MR Elastography (MRE).
1. Model Number (REF): 781278.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1953-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Evolution Upgrade 1.5T with MR Elastography (MRE).
1. Model Number (REF): 782116
2. Model Number (REF): 782148.
3. Model Number (REF): 782166.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1954-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Evolution upgrade 3.0T with MR Elastography (MRE).
1. Model Number (REF): 782143.
2. Model Number (REF): 782162.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1955-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Ingenia 1.5T with MR Elastography (MRE).
1. Model Number (REF): 781315.
2. Model Number (REF): 781341.
3. Model Number (REF): 781396.
4. Model Number (REF): 782115.
510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1956-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Ingenia 1.5T CX with MR Elastography (MRE).
1. Model Number (REF): 781262.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1957-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Ingenia 3.0T with MR Elastography (MRE).
1. Model Number (REF): 781342.
2. Model Number (REF): 781377.
3. Model Number (REF): 782103.
510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1958-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Ingenia 3.0T CX with MR Elastography (MRE).
1. Model Number (REF): 781271.
2. Model Number (REF): 782105.
510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1959-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Ingenia Ambition S with MR Elastography (MRE).
1. Model Number (REF): 781359.
2. Model Number (REF): 782108.
3. Model Number (REF): 782139.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1960-2026