Open, ClassifiedPosted Jan 30, 2026·Initiated Feb 17, 2024
Brand Name: Single Use Electrosurgical Knife KD-645
Product Name: Olympus Single Use Electrosurgical Knife KD-645
Model/Catalog Number: KD-645L
Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
Reason: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: US Nationwide distribution.Recall #Z-1223-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
Evolution Upgrade 1.5T.
Product Codes (REF): (1) 782148, (2) 782116.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1204-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
Evolution Upgrade 3.0T.
Product Code (REF): 782143.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1205-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
Ingenia 1.5T.
Product Code (REF): (1) 781341, (2) 781396.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1206-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
Ingenia 3.0T.
Product Code (REF): (1) 781342, (2) 781377.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1207-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
Ingenia 3.0T CX.
Product Code (REF): 781271.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1208-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
Ingenia Ambition S.
Product Code (REF): 782108.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1209-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
Ingenia Ambition X.
Product Code (REF): (1) 781356, (2) 782109, (3)782138.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1210-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
Ingenia Elition S.
Product Code (REF): (1) 781357, (2) 782106, (3)782137.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1211-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
Ingenia Elition X.
Product Code (REF): (1) 781358, (2) 782107, (3) 782136.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1212-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
MR 7700.
Product Code (REF): (1) 782120, (2) 782153.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1213-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
Upgrade to MR 7700.
Product Code (REF): 782130.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1214-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
SmartPath to dStream for 3.0T.
Product Code (REF): 782145.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1215-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 3, 2025
SmartPath to dStream for XR and 3.0T.
Product Code (REF): 781270.
MR systems with SW version R11.1 and R12.1.
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Root cause: Software design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.Recall #Z-1216-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Nov 6, 2025
BD Alaris" Pump Module model 8100
UDI-DI code: 10885403810046
The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces.
The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.
Reason: Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
Root cause: Under Investigation by firm
Recalling firm: CareFusion 303, Inc.Type: Pump, InfusionDistribution: U.S. Nationwide distribution in the states of AZ, IN, OH, and VA.Recall #Z-1217-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 5, 2025
Brand Name: LimFlow Vector
Product Name: LimFlow Vector
Model/Catalog Number: VT-US-23
Reason: Incorrect expiration date
Root cause: Process control
Recalling firm: LimFlow, Inc.Type: ValvulotomeDistribution: US Nationwide distribution in the states of AL, CT, District of Columbia, FL, KY, MA, MI, NE, NJ, NY, OH, PA, RI, TX, WY.Recall #Z-1218-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 22, 2025
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
Reason: BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
Root cause: Under Investigation by firm
Recalling firm: LSL Healthcare Inc.Type: Peripheral Catheter Insertion KitDistribution: US Nationwide distribution in the state of Idaho.Recall #Z-1219-2026
Open, ClassifiedPosted Jan 29, 2026·Initiated Dec 31, 2025
BEAR Implant. Model Number: 1000.
Reason: Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
Root cause: Process control
Recalling firm: Miach OrthopaedicsType: Resorbable Implant For Anterior Cruciate Ligament (Acl) RepairDistribution: US Nationwide distribution in the states of AK, CA, CO, CT, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, TX, VA, WA, WI.Recall #Z-1220-2026
Open, ClassifiedPosted Jan 28, 2026·Initiated Dec 15, 2025
Brand Name: Broselow
Product Name: Broselow Pediatric Emergency Rainbow Tape
Model/Catalog Number: 7700REA
Software Version: Not Applicable
Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
Component: No
Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Root cause: Device Design
Recalling firm: SunMed Holdings, LLCType: Emergency Response Safety KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.Recall #Z-1114-2026
Open, ClassifiedPosted Jan 28, 2026·Initiated Dec 15, 2025
Brand Name: Broselow
Product Name: Broselow Pediatric Emergency Rainbow Tape
Model/Catalog Number: 7700RE
Software Version: Not Applicable
Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
Component: No
Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Root cause: Device Design
Recalling firm: SunMed Holdings, LLCType: Emergency Response Safety KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.Recall #Z-1115-2026