Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0193-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0194-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0195-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0196-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore,
CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0197-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0198-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore,
CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0199-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore,
1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0200-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0201-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0202-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0203-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0204-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 12, 2025
Product: STA Liatest D-Di;
REF: 00515;
Reason: A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Root cause: Under Investigation by firm
Recalling firm: Diagnostica Stago, Inc.Type: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlDistribution: Worldwide distribution- US Nationwide and the country of Canada.Recall #Z-0205-2026
Open, ClassifiedPosted Oct 15, 2025·Initiated Sep 18, 2025
LOGIQ P10 series with software version R4.5.7 Model Number
5877534
Reason: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Root cause: Software design
Recalling firm: GE Medical Systems, LLCType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide. Global Distribution.Recall #Z-0155-2026
Open, ClassifiedPosted Oct 15, 2025·Initiated Sep 18, 2025
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Reason: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Root cause: Software design
Recalling firm: GE Medical Systems, LLCType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide. Global Distribution.Recall #Z-0156-2026
Open, ClassifiedPosted Oct 15, 2025·Initiated Sep 18, 2025
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Reason: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Root cause: Software design
Recalling firm: GE Medical Systems, LLCType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide. Global Distribution.Recall #Z-0157-2026
Open, ClassifiedPosted Oct 15, 2025·Initiated Sep 18, 2025
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Reason: When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.
Root cause: Nonconforming Material/Component
Recalling firm: Fisher & Paykel Healthcare, Ltd.Type: Humidifier, Respiratory Gas, (Direct Patient Interface)Distribution: US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY, FL, IL, UT, MT, OH, MI, NJ, AR, GA, WI, CA, IN, OK, CO, AL, SC, AZ, MD, WA, MO, PA, MA, NH, KY, KS, VA, CT, MN, ND, NM, NE, IA, WV, ID, NV, OR, HI, VT, RI, AL, SD, WY, PR, ME.Recall #Z-0158-2026
Open, ClassifiedPosted Oct 14, 2025·Initiated Sep 17, 2025
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Reason: IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
Root cause: Device Design
Recalling firm: Percussionaire CorporationType: Set, Tubing And Support, Ventilator (W Harness)Distribution: Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAERecall #Z-0031-2026
Open, ClassifiedPosted Oct 14, 2025·Initiated Sep 19, 2025
Brand Name: ARVIS
Product Name: ARVIS" Shoulder
Model/Catalog Number: IN-27300, Arvis Surgical Planning Software
Software Version: V2025.1.2
Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components.
Description: ARVIS Shoulder is a computer-controlled surgical navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient s preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments.
The device s workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient s CT reconstructed digital bone model and bony landmarks. The shoulder navigation application software then matches the patient s digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.
Reason: Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
Root cause: Software change control
Recalling firm: Kico Knee Innovation CompanyType: Orthopedic Augmented RealityDistribution: US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL.Recall #Z-0145-2026
Open, ClassifiedPosted Oct 14, 2025·Initiated Sep 4, 2025
XERF EFFECTOR 60. Electrosurgical unit.
Reason: Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
Root cause: Process change control
Recalling firm: Lutronic CorporationType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide - US Nationwide distribution in the states of CA, IL, MA, NJ, NY, PA, TX, and UT. The countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.Recall #Z-0146-2026