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.
- 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 - 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
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)