| Reported | Recall | Class | Product | Firm |
|---|
| 2026-01-28 | Z-1148-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number:… | Edan Diagnostics |
| 2026-01-28 | Z-1149-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number:… | Edan Diagnostics |
| 2026-01-28 | Z-1150-2026 | Class II | Brand Name: EDAN Product Name: Central Monitoring System… | Edan Diagnostics |
| 2026-01-28 | Z-1151-2026 | Class II | Brand Name: EDAN Product Name: Central Monitoring System… | Edan Diagnostics |
| 2026-01-28 | Z-1152-2026 | Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog… | Edan Diagnostics |
| 2026-01-28 | Z-1153-2026 | Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog… | Edan Diagnostics |
| 2026-01-28 | Z-1154-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number:… | Edan Diagnostics |
| 2026-01-28 | Z-1155-2026 | Class II | Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog… | Edan Diagnostics |
| 2026-01-28 | Z-1156-2026 | Class II | Patient Information Center iX | Philips North America |
| 2026-01-28 | Z-1157-2026 | Class II | SQ40S Blood Transfusion Filter | GVS TM, Inc |
| 2026-01-21 | Z-1017-2026 | Class II | VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 | Canon Medical System, USA, INC. |
| 2026-01-21 | Z-1018-2026 | Class II | VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 | Canon Medical System, USA, INC. |
| 2026-01-21 | Z-1020-2026 | Class I | FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The… | Abbott Diabetes Care, Inc. |
| 2026-01-21 | Z-1021-2026 | Class I | FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code:… | Abbott Diabetes Care, Inc. |
| 2026-01-21 | Z-1022-2026 | Class I | FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code:… | Abbott Diabetes Care, Inc. |
| 2026-01-21 | Z-1023-2026 | Class I | FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code:… | Abbott Diabetes Care, Inc. |
| 2026-01-21 | Z-1024-2026 | Class II | MAVERICK¿ Measurement Module Spectrometer PN 820-01367 | REPLIGEN CORPORATION |
| 2026-01-21 | Z-1038-2026 | Class II | Medicrea | Medicrea International |
| 2026-01-21 | Z-1039-2026 | Class II | Medicrea | Medicrea International |
| 2026-01-21 | Z-1040-2026 | Class II | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed… | Mobius Imaging, LLC |
| 2026-01-21 | Z-1041-2026 | Class II | Detachable 10in Pendant Upgrade component for the AIRO Computed… | Mobius Imaging, LLC |
| 2026-01-21 | Z-1042-2026 | Class II | Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter | Boston Scientific Corporation |
| 2026-01-21 | Z-1043-2026 | Class II | A71200 Vanta" Clinician Programmer Application | Medtronic Neuromodulation |
| 2026-01-21 | Z-1044-2026 | Class II | SMV DSX New Line | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| 2026-01-21 | Z-1045-2026 | Class II | SMV DSI | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| 2026-01-21 | Z-1046-2026 | Class II | SMV BodyTrack | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| 2026-01-21 | Z-1047-2026 | Class II | MAXXUS | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| 2026-01-21 | Z-1048-2026 | Class II | Ivenix Infusion System | Fresenius Kabi USA, LLC |
| 2026-01-21 | Z-1049-2026 | Class II | Medline Kits containing B | Medline Industries, LP |
| 2026-01-21 | Z-1050-2026 | Class II | Medline Kits containing B | Medline Industries, LP |
| 2026-01-21 | Z-1051-2026 | Class II | Medline Kits containing B | Medline Industries, LP |
| 2026-01-21 | Z-1052-2026 | Class II | Medline Kits containing B | Medline Industries, LP |
| 2026-01-21 | Z-1053-2026 | Class II | Medline Kits containing B | Medline Industries, LP |
| 2026-01-21 | Z-1054-2026 | Class II | Medline Kits containing B | Medline Industries, LP |
| 2026-01-21 | Z-1055-2026 | Class II | Medline Kits containing B | Medline Industries, LP |
| 2026-01-21 | Z-1056-2026 | Class II | Medline Kits containing B | Medline Industries, LP |
| 2026-01-21 | Z-1057-2026 | Class II | Medline Kits containing B | Medline Industries, LP |
| 2026-01-21 | Z-1058-2026 | Class II | Medline Kits containing B | Medline Industries, LP |
| 2026-01-21 | Z-1059-2026 | Class II | Medline Kits containing B | Medline Industries, LP |
| 2026-01-21 | Z-1060-2026 | Class II | Medline Kits containing B | Medline Industries, LP |
| 2026-01-21 | Z-1061-2026 | Class II | BD Ready-to-Use Hydrophilic Catheter 14 Fr | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
| 2026-01-21 | Z-1062-2026 | Class II | Product Name: Allura Xper FD10C | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1063-2026 | Class II | Allura Xper FD10F | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1064-2026 | Class II | Allura Xper FD10 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1065-2026 | Class II | Allura Xper FD10/10 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1066-2026 | Class II | Allura Xper FD20 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1067-2026 | Class II | Allura Xper FD20 Biplane | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1068-2026 | Class II | Allura Xper FD10 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1069-2026 | Class II | Allura Xper FD10/10 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1070-2026 | Class II | Allura Xper FD20 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1071-2026 | Class II | Allura Xper FD20 Biplane | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1072-2026 | Class II | Allura Xper FD20 OR Table | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1073-2026 | Class II | Allura Xper FD10 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1074-2026 | Class II | Allura Xper FD10/10 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1075-2026 | Class II | Allura Xper FD20 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1076-2026 | Class II | Allura Xper FD20/10 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1077-2026 | Class II | Allura Xper FD20/20 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1078-2026 | Class II | MOSAIQ Oncology Information System with Particle Therapy License | Elekta, Inc. |
| 2026-01-21 | Z-1079-2026 | Class II | Philips Azurion Systems R3 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1080-2026 | Class II | Brand Name: PALACOS Product Name: PALACOS R pro 40 | Heraeus Medical GmbH (Dental Division) |
| 2026-01-21 | Z-1081-2026 | Class II | Brand Name: PALACOS Product Name: PALACOS R+G pro 40 | Heraeus Medical GmbH (Dental Division) |
| 2026-01-21 | Z-1082-2026 | Class II | Brand Name: PALACOS Product Name: PALACOS MV+G pro 40 | Heraeus Medical GmbH (Dental Division) |
| 2026-01-21 | Z-1083-2026 | Class II | Brand Name: PALACOS Product Name: PALACOS MV pro 40 | Heraeus Medical GmbH (Dental Division) |
| 2026-01-21 | Z-1084-2026 | Class II | Asserachrom HPIA | Diagnostica Stago, Inc. |
| 2026-01-21 | Z-1085-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) THORACIC… | Medline Industries, LP |
| 2026-01-21 | Z-1086-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY… | Medline Industries, LP |
| 2026-01-21 | Z-1087-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) WCH… | Medline Industries, LP |
| 2026-01-21 | Z-1088-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) ROBOTIC | Medline Industries, LP |
| 2026-01-21 | Z-1089-2026 | Class II | Medline medical procedure convenience kits labeled as: 1) LAVH… | Medline Industries, LP |
| 2026-01-21 | Z-1090-2026 | Class II | Medline medical procedure convenience kits labeled as: KIT ROBOTICS… | Medline Industries, LP |
| 2026-01-21 | Z-1091-2026 | Class II | Philips Azurion Systems with software versions R2 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-01-21 | Z-1092-2026 | Class II | Brand Name: Catalyst+ Product Name: Catalyst | C-RAD POSITIONING AB |
| 2026-01-21 | Z-1093-2026 | Class II | ThinPrep¿ CytoLyt¿ Solution | Hologic, Inc |
| 2026-01-21 | Z-1094-2026 | Class II | Plum Duo Infusion System | ICU Medical, Inc. |
| 2026-01-21 | Z-1095-2026 | Class II | The product is used for the evaluation of the intrinsic coagulation… | Instrumentation Laboratory |
| 2026-01-21 | Z-1096-2026 | Class II | da Vinci SP | Intuitive Surgical, Inc. |
| 2026-01-21 | Z-1098-2026 | Class II | Abre Venous Self-Expanding Stent System | Medtronic Inc |
| 2026-01-21 | Z-1099-2026 | Class II | CentriMag Blood Pump | Thoratec LLC |
| 2026-01-21 | Z-1100-2026 | Class II | Pulsator Arterial Blood Sampling Kit | ICU Medical Inc. |
| 2026-01-21 | Z-1101-2026 | Class II | Portex Spinal Tray | ICU Medical Inc. |
| 2026-01-14 | Z-0998-2026 | Class II | The AlignRT InBore system contains six Class 1 lasers which enables… | Vision RT Ltd |
| 2026-01-14 | Z-0999-2026 | Class II | LUMINOS Lotus Max | Siemens Medical Solutions USA, Inc |
| 2026-01-14 | Z-1000-2026 | Class I | Halyard ORGAN RECOVERY OR PACK | AVID Medical, Inc. |
| 2026-01-14 | Z-1001-2026 | Class I | Halyard ORGAN RECOVERY OR PACK | AVID Medical, Inc. |
| 2026-01-14 | Z-1002-2026 | Class I | Halyard MINI PLUS KIT SOUTH | AVID Medical, Inc. |
| 2026-01-14 | Z-1003-2026 | Class II | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. |
| 2026-01-14 | Z-1009-2026 | Class II | The Elecsys Anti-TSHR immunoassay is a three-step competitive… | Roche Diagnostics Operations, Inc. |
| 2026-01-14 | Z-1010-2026 | Class II | Kii Low Profile | Applied Medical Resources Corp |
| 2026-01-14 | Z-1019-2026 | Class II | Revogene C | Meridian Bioscience Inc |
| 2026-01-14 | Z-1025-2026 | Class II | Beckman Coulter UniCel Dxl 600 | Beckman Coulter, Inc. |
| 2026-01-14 | Z-1026-2026 | Class II | Beckman Coulter UniCel Dxl 800 | Beckman Coulter, Inc. |
| 2026-01-14 | Z-1027-2026 | Class II | Philips Tempus Pro Patient Monitor | Remote Diagnostic Technologies Ltd. |
| 2026-01-14 | Z-1028-2026 | Class II | BD Pyxis ES Enterprise Server Catalog Numbers 1115-00 | CareFusion 303, Inc. |
| 2026-01-14 | Z-1029-2026 | Class II | The Pressio 2 ICP Monitoring System | Sophysa |
| 2026-01-14 | Z-1030-2026 | Class II | Impella 5 | Abiomed, Inc. |
| 2026-01-14 | Z-1031-2026 | Class II | Arial 900 MHz Call Station | Securitas Healthcare LLC |
| 2026-01-14 | Z-1032-2026 | Class II | Arial 900 MHz Call Station | Securitas Healthcare LLC |
| 2026-01-14 | Z-1033-2026 | Class II | Philips Smart-hopping 2 | Philips North America Llc |
| 2026-01-14 | Z-1034-2026 | Class II | Brand Name: HFD100 Product Name: Head Fixation Device HFD100… | IMRIS Imaging Inc |
| 2026-01-14 | Z-1035-2026 | Class II | Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK | Medline Industries, LP |
| 2026-01-14 | Z-1036-2026 | Class II | Codman Microsensor Basic Kit | Integra LifeSciences Corp. (NeuroSciences) |
| 2026-01-14 | Z-1037-2026 | Class II | Codman CereLink ICP Sensor Basic Kit | Integra LifeSciences Corp. (NeuroSciences) |
| 2026-01-07 | Z-0888-2026 | Class II | Material Processing Laser Products | SHENZHEN ATOMSTACK TECHNOLOGIES |
| 2026-01-07 | Z-1004-2026 | Class II | Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe | Vortex Surgical Inc. |
| 2026-01-07 | Z-1005-2026 | Class II | Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive… | Ferndale Laboratories, Inc. |
| 2026-01-07 | Z-1006-2026 | Class II | Sheathes3D Seamless Viral Barrier | Sheathing Technologies Inc |
| 2026-01-07 | Z-1007-2026 | Class II | Philips EPIQ Ultrasound Systems | Philips Ultrasound, LLC |
| 2026-01-07 | Z-1008-2026 | Class II | BVI Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. |