Medical DeviceNov 5, 2025
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 recall — FDA Z-0349-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
November 2025 recalls — page 11
These records include useful source details for the selected month.
Medical DeviceNov 5, 2025
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber recall — FDA Z-0359-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating recall — FDA Z-0358-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version recall — FDA Z-0321-2026
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary…
Class IIFDA: TerminatedSurgical Theater Inc.
Medical DeviceNov 5, 2025
MicroSurgical Technology MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic recall — FDA Z-0411-2026
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
Class IIFDA: OngoingMicroSurgical Technology Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Closed Vial Spike REF: CL-80 recall — FDA Z-0346-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
CareFusion 303 Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 recall — FDA Z-0369-2026
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceNov 5, 2025
Dexcom G6 and G6 Pro Android US CGM App recall — FDA Z-0318-2026
A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts…
Class IFDA: OngoingDexcom, Inc.
Medical DeviceNov 5, 2025
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 recall — FDA Z-0336-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging recall — FDA Z-0320-2026
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary…
Class IIFDA: TerminatedSurgical Theater Inc.
Medical DeviceNov 5, 2025
Alcon Laboratories, Inc. Accessory devices for Unity and Constellation surgical consoles recall — FDA Z-0306-2026
Due to incomplete seals in the pouch which provide the sterile barrier.
Class IIFDA: OngoingAlcon Research LLC
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Bag Spike REF: CL-10 recall — FDA Z-0341-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
PHILIPS MEDICAL SYSTEMS Model: Incisive CT recall — FDA Z-0375-2026
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS
Medical DeviceNov 5, 2025
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon recall — FDA Z-0338-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 recall — FDA Z-0363-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
Alcon Laboratories, Inc. Accessory devices for Unity and Constellation surgical consoles recall — FDA Z-0307-2026
Due to incomplete seals in the pouch which provide the sterile barrier.
Class IIFDA: OngoingAlcon Research LLC
Medical DeviceNov 5, 2025
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 recall — FDA Z-0342-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port recall — FDA Z-0362-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Port REF: CL2100 recall — FDA Z-0350-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
Mega Ballast recall — FDA Z-0188-2026
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Class IFDA: OngoingBALT USA, LLC
Medical DeviceNov 5, 2025
ASP Global, LLC. dba Anatomy Supply Partners SAFE-T-FILL Micro Capillary Blood Collection recall — FDA Z-0372-2026
All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare…
Class IIFDA: OngoingASP Global, LLC. dba Anatomy Supply Partners, LLC.
Medical DeviceNov 5, 2025
CareFusion 303 Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 recall — FDA Z-0368-2026
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceNov 5, 2025
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 recall — FDA Z-0331-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 recall — FDA Z-0352-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.