FDA Device · 2026
FDA Device recalls in 2026
RecallRadar indexes 2,388 FDA Device recall notices published in 2026. By classification: 287 Class I, 2,066 Class II, 35 Class III.
- EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
FDA Device · Class II · 2026-08-05 · Medtronic Perfusion Systems - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - Stryker Hoffmann II Connecting Rod Micro 3 x 50mm
FDA Device · Class II · 2026-08-05 · Stryker - EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model N…
FDA Device · Class II · 2026-08-05 · Medtronic Perfusion Systems - Stryker Hoffmann II Connecting Rod Micro 3 x 150mm
FDA Device · Class II · 2026-08-05 · Stryker - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory - GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable bloo…
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory - EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Num…
FDA Device · Class II · 2026-08-05 · Medtronic Perfusion Systems - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory - Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3
FDA Device · Class II · 2026-08-05 · Permobil - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory - Stryker Hoffmann II Connecting Rod Micro 3 x 60mm
FDA Device · Class II · 2026-08-05 · Stryker - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164
FDA Device · Class II · 2026-08-05 · Windstone Medical Packaging - MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
FDA Device · Class I · 2026-07-29 · Medline Industries - FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M…
FDA Device · Class II · 2026-07-29 · Boston Scientific - Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
FDA Device · Class II · 2026-07-29 · Olympus - Ventriculostomy Kit, REF: 46154
FDA Device · Class II · 2026-07-29 · Medtronic Neurosurgery - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
FDA Device · Class I · 2026-07-29 · Medline Industries - 3mensio Workstation (Vascular Fenestrated) software
FDA Device · Class II · 2026-07-29 · Pie Medical Imaging B V - Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O
FDA Device · Class II · 2026-07-29 · Medline Industries - FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401
FDA Device · Class II · 2026-07-29 · Boston Scientific - FARASTAR PFA Generator, Product ID M004PFCE61M460
FDA Device · Class II · 2026-07-29 · Boston Scientific - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
FDA Device · Class II · 2026-07-29 · Penumbra - FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402,…
FDA Device · Class II · 2026-07-29 · Boston Scientific - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P
FDA Device · Class II · 2026-07-29 · Medline Industries - Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12
FDA Device · Class II · 2026-07-29 · Micro Therapeutics - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenou…
FDA Device · Class II · 2026-07-29 · Icu Medical - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01
FDA Device · Class II · 2026-07-29 · Avid Medical - SnapshotGLO Wound Imaging Device, Model KB100, KB100AA
FDA Device · Class II · 2026-07-29 · Kent Imaging - MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A
FDA Device · Class I · 2026-07-29 · Medline Industries - Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system
FDA Device · Class II · 2026-07-29 · Emano Metrics - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - The intended use is to be paired with a weapon for aiming purposes
FDA Device · Class II · 2026-07-29 · Wilcox Industries - Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B
FDA Device · Class II · 2026-07-29 · Medline Industries - SeaSpine Polyaxial Head REF Number: 41-3010
FDA Device · Class II · 2026-07-29 · Seaspine Orthopedics - MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835
FDA Device · Class I · 2026-07-29 · Medline Industries - FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401
FDA Device · Class II · 2026-07-29 · Boston Scientific - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only
FDA Device · Class II · 2026-07-29 · Ferno Washington - Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit
FDA Device · Class II · 2026-07-29 · Avid Medical - Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20
FDA Device · Class II · 2026-07-29 · Micro Therapeutics - FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004…
FDA Device · Class II · 2026-07-29 · Boston Scientific - SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
FDA Device · Class II · 2026-07-29 · Alphatec Spine - Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Applia…
FDA Device · Class II · 2026-07-29 · Prismatik Dentalcraft - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons
FDA Device · Class II · 2026-07-29 · Medline Industries - Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001
FDA Device · Class II · 2026-07-29 · Boston Scientific - FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401
FDA Device · Class II · 2026-07-29 · Boston Scientific - MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
FDA Device · Class II · 2026-07-29 · Medtronic Minimed - Olympus 4K UHD LCD Monitor
FDA Device · Class II · 2026-07-29 · Olympus - Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1
FDA Device · Class II · 2026-07-29 · Karl Storz Endoscopy - MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T
FDA Device · Class I · 2026-07-29 · Medline Industries - FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C6…
FDA Device · Class II · 2026-07-29 · Boston Scientific - P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-…
FDA Device · Class II · 2026-07-29 · Paragon 28 - Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ650…
FDA Device · Class II · 2026-07-29 · Medline Industries - Papablic Replacement Brush Heads
FDA Device · Class II · 2026-07-22 · Papablic - ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Prod…
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342…
FDA Device · Class I · 2026-07-22 · Abiomed - Photera 600 3-D, phototherapy device
FDA Device · Class II · 2026-07-22 · Daavlin Distributing - Optima XR220amx, Mobile Digital-Ready Radiographic System
FDA Device · Class II · 2026-07-22 · Ge Medical Systems - Papablic Replacement Brush Heads
FDA Device · Class II · 2026-07-22 · Papablic - Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
FDA Device · Class II · 2026-07-22 · Orthofix U S - Optima XR200amx, Mobile Digital-Ready Radiographic System
FDA Device · Class II · 2026-07-22 · Ge Medical Systems - General Biospy Tray, REF: GUTS1000
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introduc…
FDA Device · Class I · 2026-07-22 · Abiomed - Rapid Refill Continuous Injection System, UPN M00566001
FDA Device · Class II · 2026-07-22 · Boston Scientific - Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and acces…
FDA Device · Class I · 2026-07-22 · Oscor - da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
FDA Device · Class II · 2026-07-22 · Intuitive Surgical - ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP
FDA Device · Class I · 2026-07-22 · Abiomed - Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart…
FDA Device · Class I · 2026-07-22 · Oscor - Arterial Line Kit 20ga x 6, REF: 400115A
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large)…
FDA Device · Class II · 2026-07-22 · 3b Medical - One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - Olympus Glass Body for 194 Ellik Evacuator
FDA Device · Class II · 2026-07-22 · Olympus - ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product…
FDA Device · Class I · 2026-07-22 · Abiomed - ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AI…
FDA Device · Class II · 2026-07-22 · Tosoh Bioscience - Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
FDA Device · Class II · 2026-07-22 · Orthofix U S - T-Lok Bone Marrow Tray, REF: BMT1104STL
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and…
FDA Device · Class I · 2026-07-22 · Oscor - Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
FDA Device · Class II · 2026-07-22 · Orthofix U S - Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010
FDA Device · Class II · 2026-07-22 · Medtronic Perfusion Systems - Olympus Toomey Evacuator 50cc with Adaptor
FDA Device · Class II · 2026-07-22 · Olympus - Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115
FDA Device · Class II · 2026-07-22 · Medtronic Perfusion Systems - Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
FDA Device · Class II · 2026-07-22 · Medline Industries - Photera 600, phototherapy device
FDA Device · Class II · 2026-07-22 · Daavlin Distributing - ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP
FDA Device · Class I · 2026-07-22 · Abiomed - ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403
FDA Device · Class II · 2026-07-22 · Icu Medical - ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401
FDA Device · Class II · 2026-07-22 · Icu Medical - Optima XR240amx, Mobile Digital Radiographic System
FDA Device · Class II · 2026-07-22 · Ge Medical Systems - ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Prod…
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Impella CP Set, Pump Set Code 0048-0044
FDA Device · Class I · 2026-07-22 · Abiomed - Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J
FDA Device · Class II · 2026-07-22 · Medline Industries - ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart…
FDA Device · Class I · 2026-07-22 · Abiomed
Other years
2026 (2,388) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)