Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 13, 2025
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer
REF:B23858
Reason: Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Root cause: Component change control
Recalling firm: Beckman Coulter Inc.Type: Counter, Differential CellDistribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV and the countries of Algeria, Argentina, Australia, Bahrain, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Egypt, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Korea Republic of, Kuwait, Kyrgyzstan, Libya, Lithuania, Mexico, Nepal, Netherlands, New Zealand, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Uruguay, Vietnam.Recall #Z-2575-2025
Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 21, 2025
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Reason: Labeling includes shelf life that has not been validated.
Root cause: Incorrect or no expiration date
Recalling firm: Folsom Metal Products, Inc.Type: Retainer, SurgicalDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.Recall #Z-2576-2025
Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 21, 2025
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Reason: Labeling includes shelf life that has not been validated.
Root cause: Incorrect or no expiration date
Recalling firm: Folsom Metal Products, Inc.Type: Retainer, SurgicalDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.Recall #Z-2577-2025
Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 21, 2025
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Reason: Labeling includes shelf life that has not been validated.
Root cause: Incorrect or no expiration date
Recalling firm: Folsom Metal Products, Inc.Type: Retainer, SurgicalDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.Recall #Z-2578-2025
Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 21, 2025
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Reason: Labeling includes shelf life that has not been validated.
Root cause: Incorrect or no expiration date
Recalling firm: Folsom Metal Products, Inc.Type: Retainer, SurgicalDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.Recall #Z-2579-2025
Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 21, 2025
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Reason: Labeling includes shelf life that has not been validated.
Root cause: Incorrect or no expiration date
Recalling firm: Folsom Metal Products, Inc.Type: Retainer, SurgicalDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.Recall #Z-2580-2025
Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 21, 2025
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Reason: Labeling includes shelf life that has not been validated.
Root cause: Incorrect or no expiration date
Recalling firm: Folsom Metal Products, Inc.Type: Retainer, SurgicalDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.Recall #Z-2581-2025
Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 21, 2025
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Reason: Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
Root cause: No Marketing Application
Recalling firm: Abbott Point Of Care Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: US Nationwide distribution.Recall #Z-2582-2025 Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 21, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25.
510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Reason: Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Root cause: No Marketing Application
Recalling firm: Abbott Point Of Care Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: US Nationwide distribution.Recall #Z-2583-2025 Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 21, 2025
i-STAT EG7+ cartridge. List Number: 03P76-25.
Reason: Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Root cause: No Marketing Application
Recalling firm: Abbott Point Of Care Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: US Nationwide distribution.Recall #Z-2584-2025 Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 21, 2025
i-STAT EG6+ cartridge. List Number: 03P77-25.
Reason: Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Root cause: No Marketing Application
Recalling firm: Abbott Point Of Care Inc.Type: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: US Nationwide distribution.Recall #Z-2585-2025 Open, ClassifiedPosted Sep 16, 2025·Initiated Feb 5, 2025
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
Reason: Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
Root cause: Software design
Recalling firm: Medical Information Technology, Inc.Type: Calculator/Data Processing Module, For Clinical UseDistribution: Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.Recall #Z-2569-2025
Open, ClassifiedPosted Sep 16, 2025·Initiated Aug 5, 2025
Pinnacle Radiation Therapy Planning System:
Multimodality Simulation Workspace 18.0.5 Model 870258
UDI code: (01)00884838103566(10)18.0.5.22236
Pinnacle TumorLOC 16.2 Model 870226
UDI code: (01)00884838091122(10)16.2.0.60010
Pinnacle TumorLOC 16.2.1 Model 870227
UDI code: (01)00884838091122(10)16.2.1.60098
Pinnacle TumorLOC 16.0.2 Model 870218
UDI code: (01)00884838085602(10)16.0.2.60004
Pinnacle TumorLOC 14.0 Model 870200
UDI code: N/A
Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.
Reason: Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Root cause: Software design
Recalling firm: Philips Medical Systems (Cleveland) IncType: System, Planning, Radiation Therapy TreatmentDistribution: U.S Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-2570-2025
Open, ClassifiedPosted Sep 15, 2025·Initiated Aug 11, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)
Model/Catalog Number: GA60461-2
Software Version: Not applicable
Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation.
Component: Not applicable
Reason: Their is the potential for weak staining which may result in false negative CD20 identification.
Root cause: Under Investigation by firm
Recalling firm: Agilent Technologies Denmark ApSType: Immunohistochemistry Reagents And KitsDistribution: US Nationwide distribution including in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.Recall #Z-2563-2025
Open, ClassifiedPosted Sep 15, 2025·Initiated Aug 11, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)
Model/Catalog Number: GA60461-2CN
Software Version: Not applicable
Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation.
Component: Not applicable
Reason: Their is the potential for weak staining which may result in false negative CD20 identification.
Root cause: Under Investigation by firm
Recalling firm: Agilent Technologies Denmark ApSType: Immunohistochemistry Reagents And KitsDistribution: US Nationwide distribution including in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.Recall #Z-2564-2025
Open, ClassifiedPosted Sep 15, 2025·Initiated Aug 11, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)
Model/Catalog Number: GA60461-2J
Software Version: Not applicable
Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation.
Component: Not applicable
Reason: Their is the potential for weak staining which may result in false negative CD20 identification.
Root cause: Under Investigation by firm
Recalling firm: Agilent Technologies Denmark ApSType: Immunohistochemistry Reagents And KitsDistribution: US Nationwide distribution including in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.Recall #Z-2565-2025
Open, ClassifiedPosted Sep 12, 2025·Initiated Aug 12, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+
Wheelchair Power Assist component.
Reason: Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
Root cause: Component design/selection
Recalling firm: Max Mobility LLCType: Wheelchair, PoweredDistribution: US: AK AL AR AZ CA CO CT DC 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 WY
OUS: CAN, NZL, KOR, BMU, GBR, JPN, TWN, AUS, BRA, COL, MEX, ABW, SWE, CHL, ARG, HKGRecall #Z-2538-2025
Open, ClassifiedPosted Sep 12, 2025·Initiated Aug 12, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+
Wheelchair Power Assist component.
Reason: Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
Root cause: Component design/selection
Recalling firm: Max Mobility LLCType: Wheelchair, PoweredDistribution: US: AK AL AR AZ CA CO CT DC 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 WY
OUS: CAN, NZL, KOR, BMU, GBR, JPN, TWN, AUS, BRA, COL, MEX, ABW, SWE, CHL, ARG, HKGRecall #Z-2539-2025
Open, ClassifiedPosted Sep 12, 2025·Initiated Aug 12, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+
Wheelchair Power Assist component.
Reason: Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
Root cause: Component design/selection
Recalling firm: Max Mobility LLCType: Wheelchair, PoweredDistribution: US: AK AL AR AZ CA CO CT DC 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 WY
OUS: CAN, NZL, KOR, BMU, GBR, JPN, TWN, AUS, BRA, COL, MEX, ABW, SWE, CHL, ARG, HKGRecall #Z-2540-2025
Open, ClassifiedPosted Sep 12, 2025·Initiated Jul 8, 2025
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Reason: Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of
therapy, return of symptoms and/or Bluetooth connectivity challenges.
Root cause: Labeling design
Recalling firm: Boston Scientific Neuromodulation CorporationType: Stimulator, Electrical, Implanted, For Parkinsonian SymptomsDistribution: Worldwide - US Nationwide distribution including in the states of MN, FL, CO, MD, NY, NE, PA, WI, AZ, TN, MO, TX, MI, MT, MA, WV, AL, VA, NC, CA, OR, WA, LA, OH, NJ, NH, SD, GA, CT, NV, UT, IN, ID, IL, ME, SC, DC, OK, KY, AK, HI, RI, AR, KS, NM and the countries of Argentina, Brazil, Chile, Ecuador, Colombia , Mexico, Canada, Japan, Algeria, Austria, Azerbaijan, Belgium, Bulgaria, Croatia, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkiye, UAE, Ukraine, United Kingdom, Hong Kong, China, Singapore, Korea, Taiwan , India, Thailand.Recall #Z-2558-2025