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.
- Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
FDA Device · Class II · 2026-07-22 · Orthofix U S - Bone Marrow Tray, REF: CB0033TL
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - ABIOMED Impella CP Set, Pump Set Code 0048-0014
FDA Device · Class I · 2026-07-22 · Abiomed - Olympus Toomey Evacuator 30cc with Adaptor
FDA Device · Class II · 2026-07-22 · Olympus - The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000
FDA Device · Class II · 2026-07-22 · Maquet Cardiovascular - ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP
FDA Device · Class I · 2026-07-22 · Abiomed - Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - Photera 400, phototherapy device
FDA Device · Class II · 2026-07-22 · Daavlin Distributing - Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb
FDA Device · Class II · 2026-07-22 · Olympus - ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460
FDA Device · Class I · 2026-07-22 · Abiomed - Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to…
FDA Device · Class II · 2026-07-15 · Olympus - Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536
FDA Device · Class II · 2026-07-15 · Siemens Healthcare Diagnostics - Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A
FDA Device · Class II · 2026-07-15 · Medline Industries - Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-…
FDA Device · Class II · 2026-07-15 · Boston Scientific Neuromodulation - GSP Neonatal GALT Kit
FDA Device · Class II · 2026-07-15 · Wallac Oy - VITEK 2 AST-N447 TEST KIT Product reference 424620
FDA Device · Class II · 2026-07-15 · Biomerieux - Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett…
FDA Device · Class II · 2026-07-15 · Cmr Surgical - 5008X Blood Tubing Set, 24 units per case
FDA Device · Class II · 2026-07-15 · Fresenius Medical Care Holdings - TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniatu…
FDA Device · Class II · 2026-07-15 · Think Surgical - Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D
FDA Device · Class II · 2026-07-15 · Medline Industries - Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee…
FDA Device · Class II · 2026-07-15 · Encore Medical - Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Flet…
FDA Device · Class II · 2026-07-15 · Elekta - Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee…
FDA Device · Class II · 2026-07-15 · Encore Medical - MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
FDA Device · Class II · 2026-07-15 · Medtronic Minimed - Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced…
FDA Device · Class II · 2026-07-15 · Elekta - KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033
FDA Device · Class II · 2026-07-15 · Klowen Braces - Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for c…
FDA Device · Class II · 2026-07-15 · Elekta - Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569
FDA Device · Class II · 2026-07-15 · Medline Industries - Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
FDA Device · Class II · 2026-07-15 · Convatec - OmniTract Surgical Retractor System, which includes 633 of the firm s product codes
FDA Device · Class II · 2026-07-15 · Integra Lifesciences Neurosciences - Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145
FDA Device · Class II · 2026-07-08 · Medline Industries - CRE Wireguided 10-12mm 240cm
FDA Device · Class II · 2026-07-08 · Boston Scientific - CRE Wireguided 15-18mm 240cm
FDA Device · Class II · 2026-07-08 · Boston Scientific - Solar GI System (Water Perfusion)
FDA Device · Class II · 2026-07-08 · Laborie Medical Technologies - Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
FDA Device · Class II · 2026-07-08 · Masimo - ARTIS icono biplane
FDA Device · Class II · 2026-07-08 · Siemens Medical Solutions Usa - MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
FDA Device · Class II · 2026-07-08 · Bd Switzerland Sarl - CRE Wireguided 6-8mm 240cm
FDA Device · Class II · 2026-07-08 · Boston Scientific - Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780
FDA Device · Class II · 2026-07-08 · Medline Industries - Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.…
FDA Device · Class II · 2026-07-08 · Medacta Usa - Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catal…
FDA Device · Class II · 2026-07-08 · Teleflex - CRE Pro Wireguided 6-8mm 240cm
FDA Device · Class II · 2026-07-08 · Boston Scientific - RayCare 2024A SP4. Oncology Information Systems
FDA Device · Class II · 2026-07-08 · Raysearch Laboratories Ab - Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474
FDA Device · Class I · 2026-07-08 · Baxter Healthcare - Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF
FDA Device · Class II · 2026-07-08 · Medline Industries - Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number:…
FDA Device · Class II · 2026-07-08 · Zimmer Surgical - ARTIS icono ceiling
FDA Device · Class II · 2026-07-08 · Siemens Medical Solutions Usa - Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270
FDA Device · Class I · 2026-07-08 · Baxter Healthcare - IntelliCuff, Portable automatic cuff pressure controller REF: 951001
FDA Device · Class II · 2026-07-08 · Hamilton Medical Ag - 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 0080174102…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
FDA Device · Class I · 2026-07-08 · Windstone Medical Packaging - CRE Wireguided 8-10mm 240cm
FDA Device · Class II · 2026-07-08 · Boston Scientific - Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U c…
FDA Device · Class II · 2026-07-08 · Baxter Healthcare - CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen U…
FDA Device · Class II · 2026-07-08 · Bard Access Systems - Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM…
FDA Device · Class II · 2026-07-08 · Depuy Ireland - Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068
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 - Omnipod 5 Pods
FDA Device · Class I · 2026-07-08 · Insulet - Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
FDA Device · Class II · 2026-07-08 · Medline Industries - CRE Pro Wireguided 15-18mm 240cm
FDA Device · Class II · 2026-07-08 · Boston Scientific - Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C
FDA Device · Class II · 2026-07-08 · Medline Industries - Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
FDA Device · Class II · 2026-07-08 · Medline Industries - Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260
FDA Device · Class II · 2026-07-08 · Medline Industries - Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085
FDA Device · Class I · 2026-07-08 · Baxter Healthcare - 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
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)