Latest medical device recalls

The 100 most recent FDA recall records that name a specific device identifier, newest first.

NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.Open, Classified
Z-3306-2026 · Noxbox Ltd · initiated Sep 14, 2026
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Open, Classified
Z-3252-2026 · Draeger, Inc. · initiated Sep 3, 2026
Potential cracks in the hose, which could lead to leakage or the hose falling off.
DxC 500 AU Clinical Chemistry Analyzers: Open, Classified
Z-0084-2027 · Beckman Coulter Inc. · initiated Sep 2, 2026 · names 2 devices
Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the d…
DxC 500i Clinical Analyzer Modules: Open, Classified
Z-0083-2027 · Beckman Coulter Inc. · initiated Sep 2, 2026 · names 3 devices
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the dra…
VERIFY Biological Steam Test Pack Open, Classified
Z-0075-2027 · Steris Corporation · initiated Aug 31, 2026
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was ef…
VERIFY Biological Steam Test Pack Open, Classified
Z-0074-2027 · Steris Corporation · initiated Aug 31, 2026
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was ef…
VERIFY Dual Species Self-Contained Biological Indicator Open, Classified
Z-0073-2027 · Steris Corporation · initiated Aug 31, 2026
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was ef…
VERIFY Dual Species Self-Contained Biological Indicator Open, Classified
Z-0072-2027 · Steris Corporation · initiated Aug 31, 2026
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was ef…
VERIFY Biological/Integrator Challenge Pack Open, Classified
Z-0071-2027 · Steris Corporation · initiated Aug 31, 2026
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was ef…
VERIFY Biological/Integrator Challenge Pack Open, Classified
Z-0070-2027 · Steris Corporation · initiated Aug 31, 2026
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was ef…
TufTex Over-the-Wire Embolectomy CatheterOpen, Classified
Z-0117-2027 · LeMaitre Vascular, Inc. · initiated Aug 28, 2026
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Evolution upgrade 1.5T amd Evolution upgrade 3.0TOpen, Classified
Z-3318-2026 · Philips North America · initiated Aug 28, 2026 · names 7 devices
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping …
Upgrade to MR 7700Open, Classified
Z-3317-2026 · Philips North America · initiated Aug 28, 2026
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping …
Upgrade dStreamOpen, Classified
Z-3316-2026 · Philips North America · initiated Aug 28, 2026
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping …
SmartPath to MR 7700Open, Classified
Z-3315-2026 · Philips North America · initiated Aug 28, 2026 · names 2 devices
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping …
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartOpen, Classified
Z-3314-2026 · Philips North America · initiated Aug 28, 2026 · names 12 devices
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping …
MR 7700Open, Classified
Z-3313-2026 · Philips North America · initiated Aug 28, 2026 · names 4 devices
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping …
MR 5300Open, Classified
Z-3312-2026 · Philips North America · initiated Aug 28, 2026 · names 4 devices
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping …
Ingenia Elition S and Ingenia Elition X.Open, Classified
Z-3311-2026 · Philips North America · initiated Aug 28, 2026 · names 10 devices
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping …
Ingenia Ambition S and Ingenia Ambition X.Open, Classified
Z-3310-2026 · Philips North America · initiated Aug 28, 2026 · names 10 devices
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping …
Ingenia 3.0T and 3.0T CXOpen, Classified
Z-3309-2026 · Philips North America · initiated Aug 28, 2026 · names 4 devices
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping …
Ingenia 1.5T, 1.5T CX, and 1.5T SOpen, Classified
Z-3308-2026 · Philips North America · initiated Aug 28, 2026 · names 7 devices
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping …
Ingenia Blue Seal SE and Blue Seal XEOpen, Classified
Z-3307-2026 · Philips North America · initiated Aug 28, 2026 · names 2 devices
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping …
Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241Open, Classified
Z-0119-2027 · Intellijoint Surgical, Inc. · initiated Aug 28, 2026 · names 3 devices
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk.
Alphenix INFX-8000C/B5Open, Classified
Z-0108-2027 · Canon Medical System, USA, INC. · initiated Aug 26, 2026
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
Brand Name: ASP Global Open, Classified
Z-0048-2027 · ASP Global, LLC. · initiated Aug 24, 2026
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Open, Classified
Z-0047-2027 · ASP Global, LLC. · initiated Aug 24, 2026
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Open, Classified
Z-0046-2027 · ASP Global, LLC. · initiated Aug 24, 2026
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Open, Classified
Z-0045-2027 · ASP Global, LLC. · initiated Aug 24, 2026
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Open, Classified
Z-0044-2027 · ASP Global, LLC. · initiated Aug 24, 2026
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Open, Classified
Z-0043-2027 · ASP Global, LLC. · initiated Aug 24, 2026
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Open, Classified
Z-0042-2027 · ASP Global, LLC. · initiated Aug 24, 2026
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Open, Classified
Z-0041-2027 · ASP Global, LLC. · initiated Aug 24, 2026
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Open, Classified
Z-0040-2027 · ASP Global, LLC. · initiated Aug 24, 2026
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Open, Classified
Z-0039-2027 · ASP Global, LLC. · initiated Aug 24, 2026
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Open, Classified
Z-0038-2027 · ASP Global, LLC. · initiated Aug 24, 2026
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.Open, Classified
Z-3300-2026 · Olympus Corporation of the Americas · initiated Aug 24, 2026
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.Open, Classified
Z-3299-2026 · Olympus Corporation of the Americas · initiated Aug 24, 2026
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Imager II Angiographic CathetersOpen, Classified
Z-3214-2026 · Boston Scientific Corporation · initiated Aug 24, 2026 · names 26 devices
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
Spectral CT and Spectral CT 7500 RTOpen, Classified
Z-0078-2027 · Philips Medical Systems · initiated Aug 21, 2026 · names 3 devices
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath Open, Classified
Z-3243-2026 · Philips North America Llc · initiated Aug 21, 2026 · names 9 devices
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
MR 7700 and Upgrade to MR 7700Open, Classified
Z-3242-2026 · Philips North America Llc · initiated Aug 21, 2026 · names 3 devices
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
MR 5300Open, Classified
Z-3241-2026 · Philips North America Llc · initiated Aug 21, 2026
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175)Open, Classified
Z-3240-2026 · Philips North America Llc · initiated Aug 21, 2026
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Ingenia Elition S and Ingenia Elition XOpen, Classified
Z-3239-2026 · Philips North America Llc · initiated Aug 21, 2026 · names 8 devices
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Ingenia 3.0T and Ingenia 3.0T CXOpen, Classified
Z-3238-2026 · Philips North America Llc · initiated Aug 21, 2026 · names 5 devices
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Ingenia Ambition S and Ingenia Ambition XOpen, Classified
Z-3237-2026 · Philips North America Llc · initiated Aug 21, 2026 · names 6 devices
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T SOpen, Classified
Z-3236-2026 · Philips North America Llc · initiated Aug 21, 2026 · names 8 devices
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Evolution upgrade 1.5T and Evolution upgrade 3.0TOpen, Classified
Z-3235-2026 · Philips North America Llc · initiated Aug 21, 2026 · names 3 devices
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial systemOpen, Classified
Z-3232-2026 · Philips North America Llc · initiated Aug 21, 2026
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rOpen, Classified
Z-3220-2026 · Midmark Corporation · initiated Aug 21, 2026 · names 2 devices
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rOpen, Classified
Z-3219-2026 · Midmark Corporation · initiated Aug 21, 2026 · names 2 devices
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rOpen, Classified
Z-3218-2026 · Midmark Corporation · initiated Aug 21, 2026 · names 2 devices
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rOpen, Classified
Z-3217-2026 · Midmark Corporation · initiated Aug 21, 2026 · names 2 devices
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526Open, Classified
Z-3274-2026 · Alere San Diego, Inc. · initiated Aug 20, 2026 · names 6 devices
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527Open, Classified
Z-3273-2026 · Alere San Diego, Inc. · initiated Aug 20, 2026 · names 6 devices
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528Open, Classified
Z-3272-2026 · Alere San Diego, Inc. · initiated Aug 20, 2026 · names 5 devices
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062Open, Classified
Z-0088-2027 · Medtronic MiniMed, Inc. · initiated Aug 20, 2026 · names 2 devices
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users potentially have…
REF: 81-030415Open, Classified
Z-3256-2026 · DeRoyal Industries Inc · initiated Aug 20, 2026
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
PALACOS MV pro 40Open, Classified
Z-3304-2026 · Heraeus Medical GmbH (Dental Division) · initiated Aug 20, 2026 · names 2 devices
Potential for monomer liquid leakage.
PALACOS MV+G pro 40Open, Classified
Z-3303-2026 · Heraeus Medical GmbH (Dental Division) · initiated Aug 20, 2026 · names 2 devices
Potential for monomer liquid leakage.
PALACOS R+G pro 40Open, Classified
Z-3302-2026 · Heraeus Medical GmbH (Dental Division) · initiated Aug 20, 2026 · names 2 devices
Potential for monomer liquid leakage.
PALACOS R pro 40Open, Classified
Z-3301-2026 · Heraeus Medical GmbH (Dental Division) · initiated Aug 20, 2026 · names 2 devices
Potential for monomer liquid leakage.
CADD Yellow Medication Cassette Reservoir with NRFit connectorOpen, Classified
Z-3212-2026 · ICU Medical, Inc. · initiated Aug 20, 2026 · names 2 devices
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model Open, Classified
Z-3275-2026 · Bard Peripheral Vascular Inc · initiated Aug 20, 2026 · names 2 devices
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or…
Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTATOpen, Classified
Z-3177-2026 · Wilson-Cook Medical Inc. · initiated Aug 20, 2026 · names 2 devices
Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001Open, Classified
Z-3271-2026 · Alere San Diego, Inc. · initiated Aug 20, 2026 · names 8 devices
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Presource Packs containing Medtronic Microstream Components: Open, Classified
Z-0079-2027 · Cardinal Health 200, LLC · initiated Aug 19, 2026 · names 6 devices
Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and uni…
SeaSpine Mariner DeformityOpen, Classified
Z-3226-2026 · Seaspine Orthopedics Corporation · initiated Aug 19, 2026
The proximal thread depth of the spinal device is out of design specification.
REF:B5STOpen, Classified
Z-3187-2026 · Stryker Sustainability Solutions · initiated Aug 19, 2026
Reusable access port system may crack or seperate during use.
REF:B5LTOpen, Classified
Z-3186-2026 · Stryker Sustainability Solutions · initiated Aug 19, 2026
Reusable access port system may crack or seperate during use.
REF:B12LTOpen, Classified
Z-3185-2026 · Stryker Sustainability Solutions · initiated Aug 19, 2026
Reusable access port system may crack or seperate during use.
REF:B11LTOpen, Classified
Z-3184-2026 · Stryker Sustainability Solutions · initiated Aug 19, 2026
Reusable access port system may crack or seperate during use.
REF:2B5STOpen, Classified
Z-3183-2026 · Stryker Sustainability Solutions · initiated Aug 19, 2026
Reusable access port system may crack or seperate during use.
REF:2B5LTOpen, Classified
Z-3182-2026 · Stryker Sustainability Solutions · initiated Aug 19, 2026
Reusable access port system may crack or seperate during use.
NOxBOXi Nitric Oxide Delivery System.Open, Classified
Z-3165-2026 · Noxbox Ltd · initiated Aug 19, 2026
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.Open, Classified
Z-3247-2026 · Olympus Corporation of the Americas · initiated Aug 19, 2026
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.Open, Classified
Z-3246-2026 · Olympus Corporation of the Americas · initiated Aug 19, 2026
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.Open, Classified
Z-3245-2026 · Olympus Corporation of the Americas · initiated Aug 19, 2026
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.Open, Classified
Z-3244-2026 · Olympus Corporation of the Americas · initiated Aug 19, 2026
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
BD Alaris Pump Infusion SetsOpen, Classified
Z-3080-2026 · Bd Switzerland Sarl · initiated Aug 19, 2026 · names 49 devices
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Philips Medical SystemsOpen, Classified
Z-3155-2026 · Philips North America Llc · initiated Aug 18, 2026
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:Open, Classified
Z-3298-2026 · Cardinal Health 200, LLC · initiated Aug 18, 2026
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:Open, Classified
Z-3297-2026 · Cardinal Health 200, LLC · initiated Aug 18, 2026 · names 10 devices
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:Open, Classified
Z-3296-2026 · Cardinal Health 200, LLC · initiated Aug 18, 2026 · names 8 devices
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:Open, Classified
Z-3295-2026 · Cardinal Health 200, LLC · initiated Aug 18, 2026 · names 10 devices
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009Open, Classified
Z-3325-2026 · Percussionaire Corporation · initiated Aug 18, 2026 · names 2 devices
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hype…
Travel Air, Product Number: S00055Open, Classified
Z-3324-2026 · Percussionaire Corporation · initiated Aug 18, 2026 · names 2 devices
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hype…
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction ManualOpen, Classified
Z-3323-2026 · Percussionaire Corporation · initiated Aug 18, 2026 · names 2 devices
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hype…
Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-COpen, Classified
Z-3322-2026 · Percussionaire Corporation · initiated Aug 18, 2026 · names 6 devices
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hype…
Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-COpen, Classified
Z-3321-2026 · Percussionaire Corporation · initiated Aug 18, 2026 · names 6 devices
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hype…
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007Open, Classified
Z-0085-2027 · Stryker Sustainability Solutions · initiated Aug 18, 2026
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating SystemOpen, Classified
Z-3334-2026 · Wright Medical Technology, Inc. · initiated Aug 18, 2026
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongati…
In-Line Valve, Product Number: P5-TEEOpen, Classified
Z-3320-2026 · Percussionaire Corporation · initiated Aug 18, 2026
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hype…
Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065Open, Classified
Z-3319-2026 · Percussionaire Corporation · initiated Aug 18, 2026 · names 3 devices
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hype…
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action.Open, Classified
Z-3035-2026 · Olympus Corporation of the Americas · initiated Aug 18, 2026
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intakeOpen, Classified
Z-3264-2026 · Baxter Healthcare Corporation · initiated Aug 18, 2026
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in u…
PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intakeOpen, Classified
Z-3263-2026 · Baxter Healthcare Corporation · initiated Aug 18, 2026
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in u…
PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered systemOpen, Classified
Z-3262-2026 · Baxter Healthcare Corporation · initiated Aug 18, 2026
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in u…
Atellica CH Revised C-Reactive Protein (RCRP)Open, Classified
Z-3335-2026 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 17, 2026
The potential for falsely elevated results.