FDA Device · 2026
FDA Device recalls in 2026
RecallRadar indexes 2,024 FDA Device recall notices published in 2026. By classification: 254 Class I, 1,736 Class II, 34 Class III.
- 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposabl…
FDA Device · Class II · 2026-07-08 · Covidien - A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
FDA Device · Class I · 2026-07-08 · Windstone Medical Packaging - Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215
FDA Device · Class II · 2026-07-08 · Medline Industries - A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
FDA Device · Class I · 2026-07-08 · Windstone Medical Packaging - ARTIS icono ceiling
FDA Device · Class II · 2026-07-08 · Siemens Medical Solutions Usa - Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTE…
FDA Device · Class II · 2026-07-08 · Depuy Ireland - Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B
FDA Device · Class II · 2026-07-08 · Medline Industries - 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dial…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - RayCare 2024A SP1. Oncology Information Systems
FDA Device · Class II · 2026-07-08 · Raysearch Laboratories Ab - Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ9…
FDA Device · Class II · 2026-07-08 · Medline Industries - Medtronic Harmony Delivery Catheter System
FDA Device · Class I · 2026-07-08 · Medtronic Heart Valves Division - Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520
FDA Device · Class II · 2026-07-08 · Medline Industries - GC Agar Base (150mm) 10/PK R04030
FDA Device · Class II · 2026-07-08 · Remel - Omnipod DASH Pod
FDA Device · Class I · 2026-07-08 · Insulet - Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED…
FDA Device · Class II · 2026-07-08 · Medline Industries - Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology…
FDA Device · Class I · 2026-07-08 · Medline Industries - CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
FDA Device · Class II · 2026-07-08 · Medline Industries - Radius VSM ECG pre-connected Set, REF: 4842, 4695
FDA Device · Class II · 2026-07-08 · Masimo - CRE Pro Wireguided 18-20mm 240cm
FDA Device · Class II · 2026-07-08 · Boston Scientific - Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B
FDA Device · Class II · 2026-07-08 · Medline Industries - ARTIS icono floor
FDA Device · Class II · 2026-07-08 · Siemens Medical Solutions Usa - Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60…
FDA Device · Class II · 2026-07-08 · Zimmer Surgical - CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G
FDA Device · Class II · 2026-07-08 · Medline Industries - CRE Wireguided 12-15mm 240cm
FDA Device · Class II · 2026-07-08 · Boston Scientific - Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
FDA Device · Class II · 2026-07-08 · Medline Industries - Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407
FDA Device · Class II · 2026-07-08 · Medline Industries - Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer
FDA Device · Class II · 2026-07-08 · Accuray - A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
FDA Device · Class I · 2026-07-08 · Windstone Medical Packaging - CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code:…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
FDA Device · Class II · 2026-07-08 · Carl Zeiss Meditec Ag - Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
FDA Device · Class II · 2026-07-08 · Medline Industries - CRE Pro Wireguided 12-15mm 240cm
FDA Device · Class II · 2026-07-08 · Boston Scientific - GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada…
FDA Device · Class II · 2026-07-08 · W L Gore And Associates - CRE Pro Wireguided 8-10mm 240cm
FDA Device · Class II · 2026-07-08 · Boston Scientific - 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialy…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473
FDA Device · Class I · 2026-07-08 · Baxter Healthcare - Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Pr…
FDA Device · Class II · 2026-07-08 · Medela - SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
FDA Device · Class II · 2026-07-08 · Mentor Texas - Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVE…
FDA Device · Class II · 2026-07-08 · Medline Industries - OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 01108854031083…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators
FDA Device · Class I · 2026-07-08 · Hamilton Medical Ag - 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tis…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L
FDA Device · Class II · 2026-07-08 · Medline Industries - CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 008…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code:…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A
FDA Device · Class II · 2026-07-08 · Medline Industries - CRE Pro Wireguided 10-12mm 240cm
FDA Device · Class II · 2026-07-08 · Boston Scientific - Omnipod (Eros) Pod
FDA Device · Class I · 2026-07-08 · Insulet - CRE Wireguided 18-20mm 240cm
FDA Device · Class II · 2026-07-08 · Boston Scientific - 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 da…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995
FDA Device · Class II · 2026-07-08 · Medline Industries - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
FDA Device · Class II · 2026-07-01 · Medline Industries - GE Healthcare AW Server 3.2 ext.6.5
FDA Device · Class II · 2026-07-01 · Ge Medical Systems Scs - Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
FDA Device · Class II · 2026-07-01 · Philips North America - Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
FDA Device · Class II · 2026-07-01 · Zimmer - Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890
FDA Device · Class I · 2026-07-01 · Medline Industries - Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - Multi-Snare Set: 5 mm x 125 cm, REF: 147305
FDA Device · Class II · 2026-07-01 · Pfm Medical - Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
FDA Device · Class II · 2026-07-01 · Zimmer - Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
FDA Device · Class II · 2026-07-01 · Medline Industries - Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
FDA Device · Class II · 2026-07-01 · Zimmer - Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - Da Vinci ASSY, PSS, SP1098, Part Number: 380601
FDA Device · Class II · 2026-07-01 · Intuitive Surgical - Octopus 4 Tissue Stabilizer, Model 29400
FDA Device · Class II · 2026-07-01 · Medtronic Perfusion Systems - Octopus Evolution Tissue Stabilizer, Model TS2000
FDA Device · Class II · 2026-07-01 · Medtronic Perfusion Systems - Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number…
FDA Device · Class II · 2026-07-01 · Dexcom - Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232
FDA Device · Class II · 2026-07-01 · Philips North America - Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
FDA Device · Class II · 2026-07-01 · Medline Industries - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
FDA Device · Class II · 2026-07-01 · Medline Industries - Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q
FDA Device · Class I · 2026-07-01 · Medline Industries - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
FDA Device · Class II · 2026-07-01 · Medline Industries - TMJ Bilateral Implants, REF: CHG020
FDA Device · Class II · 2026-07-01 · Tmj Solutions - Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
FDA Device · Class II · 2026-07-01 · Boston Scientific - Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
FDA Device · Class II · 2026-07-01 · Philips North America - Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
FDA Device · Class II · 2026-07-01 · Medline Industries - Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435
FDA Device · Class I · 2026-07-01 · Abiomed - Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434
FDA Device · Class I · 2026-07-01 · Abiomed - Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits
FDA Device · Class I · 2026-07-01 · Abiomed - Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan
FDA Device · Class I · 2026-07-01 · Abiomed - Octopus Evolution AS Tissue Stabilizer, Model TS2500
FDA Device · Class II · 2026-07-01 · Medtronic Perfusion Systems - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
FDA Device · Class II · 2026-07-01 · Medline Industries - Thuvera Laser Console
FDA Device · Class II · 2026-07-01 · Ipg Medical - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
FDA Device · Class II · 2026-07-01 · Medline Industries - Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP
FDA Device · Class I · 2026-07-01 · Medline Industries - Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1
FDA Device · Class II · 2026-07-01 · Surgify Medical Oy - INZONE DETACHMENT SYSTEM, REF: M00345100950
FDA Device · Class II · 2026-07-01 · Stryker Neurovascular
Other years
2026 (2,024) · 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)