Open, ClassifiedPosted Sep 19, 2025·Initiated Aug 13, 2025
Philips CT systems labeled as the following:
1. IQon Spectral CT, Model Number: 728332.
Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Root cause: Process control
Recalling firm: Philips North America LlcType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.Recall #Z-2601-2025 Open, ClassifiedPosted Sep 19, 2025·Initiated Aug 13, 2025
Philips CT systems labeled as the following:
1. Ingenuity Core128 / Elite China, Model Number: 728324.
Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Root cause: Process control
Recalling firm: Philips North America LlcType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.Recall #Z-2602-2025 Open, ClassifiedPosted Sep 19, 2025·Initiated Aug 13, 2025
Philips CT systems labeled as the following:
1. Ingenuity CT Family Brazil, Model Number: 728325.
Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Root cause: Process control
Recalling firm: Philips North America LlcType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.Recall #Z-2603-2025 Open, ClassifiedPosted Sep 19, 2025·Initiated Aug 13, 2025
Philips CT systems labeled as the following:
1. CT 6000, Model Number: 728307.
Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Root cause: Process control
Recalling firm: Philips North America LlcType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.Recall #Z-2604-2025 Open, ClassifiedPosted Sep 19, 2025·Initiated Aug 15, 2025
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.
Reason: Potential for barb non-engagement.
Root cause: Under Investigation by firm
Recalling firm: ETHICON, LLCType: Suture, Surgical, Absorbable, PolydioxanoneDistribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, IL, IN, KS, MA, MD, MI, MO, MN, NC, NH, NM, TX, VA, WA, WI and the countries of Singapore and Malaysia.Recall #Z-2605-2025
Open, ClassifiedPosted Sep 19, 2025·Initiated Aug 22, 2025
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric.
54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Reason: One lot manufactured with an invalid sterilization cycle.
Root cause: Under Investigation by firm
Recalling firm: CooperVision, Inc.Type: Lens, Contact, (Disposable)Distribution: US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.Recall #Z-2606-2025
Open, ClassifiedPosted Sep 19, 2025·Initiated Aug 22, 2025
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables.
54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Reason: One lot manufactured with an invalid sterilization cycle.
Root cause: Under Investigation by firm
Recalling firm: CooperVision, Inc.Type: Lens, Contact, (Disposable)Distribution: US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.Recall #Z-2607-2025
Open, ClassifiedPosted Sep 19, 2025·Initiated Aug 22, 2025
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric.
54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Reason: One lot manufactured with an invalid sterilization cycle.
Root cause: Under Investigation by firm
Recalling firm: CooperVision, Inc.Type: Lens, Contact, (Disposable)Distribution: US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.Recall #Z-2608-2025
Open, ClassifiedPosted Sep 19, 2025·Initiated Jul 10, 2025
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.
Reason: FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Root cause: Component design/selection
Recalling firm: Biofire DefenseDistribution: US Nationwide distribution in the states of AL, AZ, UT, CA, TX, DC , VA, FL, MD, OH, HI, NY, KY, LA, MA, MI, MN, MO, NC, NH, RI, NV, TN, IA, WA.Recall #Z-2609-2025
Open, ClassifiedPosted Sep 18, 2025·Initiated Apr 10, 2025
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Reason: Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.
Root cause: Device Design
Recalling firm: 3M CompanyType: Warmer, Blood, Non-Electromagnetic RadiationDistribution: Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Canary Islands, China, Costa Rica, Croatia, Czechia, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Korea, Luxembourg, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, UK, and Vietnam.Recall #Z-2483-2025
Open, ClassifiedPosted Sep 18, 2025·Initiated Aug 29, 2025
The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
Reason: The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). The product has a radiation safety defect, in that these radiation emissions are unnecessary to the accomplishment of the product s primary purpose of disinfecting objects and surfaces, and create a risk of skin and/or eye injuries to user and nearby persons.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: BigTree Sales Inc.Type: Uv Lamp, GermicidalDistribution: U.S.ARecall #Z-2571-2025
Open, ClassifiedPosted Sep 18, 2025·Initiated Aug 15, 2025
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Reason: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Root cause: Under Investigation by firm
Recalling firm: Maquet Cardiovascular, LLCType: Clamp, VascularDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.Recall #Z-2586-2025
Open, ClassifiedPosted Sep 18, 2025·Initiated Aug 15, 2025
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Reason: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Root cause: Under Investigation by firm
Recalling firm: Maquet Cardiovascular, LLCType: Clamp, VascularDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.Recall #Z-2587-2025
Open, ClassifiedPosted Sep 18, 2025·Initiated Aug 15, 2025
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Reason: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Root cause: Under Investigation by firm
Recalling firm: Maquet Cardiovascular, LLCType: Clamp, VascularDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.Recall #Z-2588-2025
Open, ClassifiedPosted Sep 18, 2025·Initiated Jul 17, 2025
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Root cause: Labeling mix-ups
Recalling firm: C.R. Bard IncType: Catheter, Urological (Antimicrobial) And AccessoriesDistribution: US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.Recall #Z-2589-2025
Open, ClassifiedPosted Sep 18, 2025·Initiated Jul 17, 2025
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Root cause: Labeling mix-ups
Recalling firm: C.R. Bard IncType: Catheter, Urological (Antimicrobial) And AccessoriesDistribution: US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.Recall #Z-2590-2025
Open, ClassifiedPosted Sep 18, 2025·Initiated Jul 17, 2025
SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216
Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Root cause: Labeling mix-ups
Recalling firm: C.R. Bard IncType: Catheter, Urological (Antimicrobial) And AccessoriesDistribution: US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.Recall #Z-2591-2025
Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 13, 2025
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer
REF: C11478
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-2572-2025
Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 13, 2025
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer
REF: C34520
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-2573-2025
Open, ClassifiedPosted Sep 17, 2025·Initiated Aug 13, 2025
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer
REFs:B24802, 629029, B63322
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-2574-2025