Open, ClassifiedPosted Jul 29, 2026·Initiated May 8, 2026
Brand Name: GEM Premier 7000 with iQM3
Product Name: GEM Premier 7000 with iQM3
Model/Catalog Number: 00000015279
Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000.
Reason: BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.
Root cause: Software Design Change
Recalling firm: Instrumentation LaboratoryType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: US Nationwide distribution.Recall #Z-2822-2026 Open, ClassifiedPosted Jul 29, 2026·Initiated May 8, 2026
Brand Name: GEM Premier 5000
Product Name: GEM Premier 5000
Model/Catalog Number: 00024019255
Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples.
Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC).
Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.
The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths.
Reason: BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.
Root cause: Software Design Change
Recalling firm: Instrumentation LaboratoryType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: US Nationwide distribution. Open, ClassifiedPosted Jul 29, 2026·Initiated May 8, 2026
Brand Name: GEM Premier 5000
Product Name: GEM Premier 5000
Model/Catalog Number: 00024019255
Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples.
Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC).
Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.
The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths.
Reason: BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.
Root cause: Software Design Change
Recalling firm: Instrumentation LaboratoryType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: US Nationwide distribution. Open, ClassifiedPosted Jul 29, 2026·Initiated May 8, 2026
Brand Name: GEM Premier 5000
Product Name: GEM Premier 5000
Model/Catalog Number: 00024019255
Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples.
Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC).
Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.
The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths.
Reason: BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.
Root cause: Software Design Change
Recalling firm: Instrumentation LaboratoryType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: US Nationwide distribution. Open, ClassifiedPosted Jul 29, 2026·Initiated May 8, 2026
Brand Name: GEM Premier 5000
Product Name: GEM Premier 5000
Model/Catalog Number: 00024019255
Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples.
Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC).
Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.
The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths.
Reason: BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.
Root cause: Software Design Change
Recalling firm: Instrumentation LaboratoryType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: US Nationwide distribution. Open, ClassifiedPosted Jul 29, 2026·Initiated Jul 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
Reason: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Root cause: Device Design
Recalling firm: Stryker GmbHType: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentDistribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,
ID, IL, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA,
WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, UK.Recall #Z-2827-2026
Open, ClassifiedPosted Jul 29, 2026·Initiated Jul 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.
Reason: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Root cause: Device Design
Recalling firm: Stryker GmbHType: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentDistribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,
ID, IL, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA,
WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, UK.Recall #Z-2828-2026
Open, ClassifiedPosted Jul 29, 2026·Initiated Jul 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
Reason: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Root cause: Device Design
Recalling firm: Stryker GmbHType: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentDistribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,
ID, IL, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA,
WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, UK.Recall #Z-2829-2026
Open, ClassifiedPosted Jul 29, 2026·Initiated Jul 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
Reason: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Root cause: Device Design
Recalling firm: Stryker GmbHType: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentDistribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,
ID, IL, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA,
WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, UK.Recall #Z-2830-2026
Open, ClassifiedPosted Jul 29, 2026·Initiated Jul 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.
Reason: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Root cause: Device Design
Recalling firm: Stryker GmbHType: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentDistribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,
ID, IL, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA,
WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, UK.Recall #Z-2831-2026
Open, ClassifiedPosted Jul 29, 2026·Initiated Jul 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
Reason: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Root cause: Device Design
Recalling firm: Stryker GmbHType: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentDistribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,
ID, IL, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA,
WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, UK.Recall #Z-2832-2026
Open, ClassifiedPosted Jul 29, 2026·Initiated Jul 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
Reason: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Root cause: Device Design
Recalling firm: Stryker GmbHType: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentDistribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA,
ID, IL, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA,
WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, UK.Recall #Z-2833-2026
Open, ClassifiedPosted Jul 28, 2026·Initiated Jun 25, 2026
Resmed Astral 100/150
Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.
Reason: Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
Root cause: Component design/selection
Recalling firm: ResMed Ltd.Type: Ventilator, Continuous, Facility UseDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, 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 Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Israel, Italy, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Martin (French part), Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, and Viet Nam.Recall #Z-2735-2026
Open, ClassifiedPosted Jul 28, 2026·Initiated Jul 2, 2026
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095.
Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Reason: Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
Root cause: Process control
Recalling firm: IsoTis OrthoBiologics, Inc.Type: Filler, Bone Void, Calcium CompoundDistribution: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.Recall #Z-2820-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 11, 2026
Brilliance iCT
Brilliance iCT Upgrades
Brilliance iCT SP
Brilliance CT 64 Channel
CT6000
Brilliance 64 Upgrades
Reason: The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: PHILIPS MEDICAL SYSTEMSType: System, X-Ray, Tomography, ComputedDistribution: US Nationwide Distribution including Puerto RicoRecall #Z-2650-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 11, 2026
IQon Spectral CT
IQon Spectral CT Upgrades
Reason: The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: PHILIPS MEDICAL SYSTEMSType: System, X-Ray, Tomography, ComputedDistribution: US Nationwide Distribution including Puerto RicoRecall #Z-2651-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 11, 2026
Ingenuity CT
CT5000 Ingenuity Plus
CT5000 Ingenuity Pro
CT5000 Ingenuity Premium
Ingenuity CT Upgrades
Ingenuity CT China
Ingenuity Core 128 Elite Brazil
Reason: The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: PHILIPS MEDICAL SYSTEMSType: System, X-Ray, Tomography, ComputedDistribution: US Nationwide Distribution including Puerto RicoRecall #Z-2652-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 24, 2026
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
Reason: Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution.Recall #Z-2806-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 24, 2026
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
Reason: Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution.Recall #Z-2807-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 24, 2026
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
Reason: Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution.Recall #Z-2808-2026