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.
- Artelon FlexBand Dynamic Matrix Ref: 31057
FDA Device · Class II · 2026-03-18 · International Life Sciences - Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A,…
FDA Device · Class III · 2026-03-18 · Penner Patient Care - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Penner Pacific Bathing Spa, Model Numbers 360020-1P
FDA Device · Class III · 2026-03-18 · Penner Patient Care - Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices
FDA Device · Class I · 2026-03-18 · Trividia Health - Penner Pacific Bathing Spa, Model Numbers 360020-1EP
FDA Device · Class III · 2026-03-18 · Penner Patient Care - Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
FDA Device · Class II · 2026-03-18 · Exactech - Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices
FDA Device · Class I · 2026-03-18 · Trividia Health - Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A
FDA Device · Class II · 2026-03-18 · Medline Industries - GEM Premier 5000 PAK, Part No. 00055360004
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - 10mL Non-Sterile BD Luer-Lok Tip Syringe Only
FDA Device · Class II · 2026-03-18 · Becton Dickinson And - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Endo-Model SL Connection Component incl
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
FDA Device · Class II · 2026-03-18 · International Life Sciences - Endo-Model Replacement Plateau
FDA Device · Class II · 2026-03-18 · Waldemar Link And Kg Mfg Site - Artelon FlexBand Plus Ref: 41054 & 41057
FDA Device · Class II · 2026-03-18 · International Life Sciences - Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
FDA Device · Class III · 2026-03-18 · Penner Patient Care - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - CLARITY II Laser System
FDA Device · Class II · 2026-03-18 · Lutronic - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt…
FDA Device · Class II · 2026-03-18 · Raz Design - GEM Premier 5000
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - GEM Premier 5000 PAK
FDA Device · Class II · 2026-03-18 · Instrumentation Laboratory - HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes…
FDA Device · Class II · 2026-03-18 · Covidien - Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices
FDA Device · Class I · 2026-03-18 · Trividia Health - MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
FDA Device · Class II · 2026-03-18 · Kob - Olympus Single Use Biopsy Valve
FDA Device · Class II · 2026-03-11 · Olympus - CS300 IABP. Software Version CS300 IABP C.01
FDA Device · Class II · 2026-03-11 · Datascope - Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Descript…
FDA Device · Class II · 2026-03-11 · B Braun Medical - Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE,…
FDA Device · Class II · 2026-03-11 · Vascutek - Olympus Single use Biopsy Valve
FDA Device · Class II · 2026-03-11 · Olympus - Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA Device · Class II · 2026-03-11 · Esaote S P A - Impella RP with SmartAssist
FDA Device · Class I · 2026-03-11 · Abiomed - Atellica CH Urine Albumin (UAlb)
FDA Device · Class II · 2026-03-11 · Siemens Healthcare Diagnostics - EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
FDA Device · Class II · 2026-03-11 · Staar Surgical Ag - CS100 IABP. Software Version CS100 IABP Q.01
FDA Device · Class II · 2026-03-11 · Datascope - Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model…
FDA Device · Class II · 2026-03-11 · Olympus - Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Descr…
FDA Device · Class II · 2026-03-11 · Aesculap - GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047
FDA Device · Class II · 2026-03-11 · Ge Healthcare - Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The…
FDA Device · Class II · 2026-03-11 · Diagnostica Stago - Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description:…
FDA Device · Class II · 2026-03-11 · B Braun Medical - Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product…
FDA Device · Class II · 2026-03-11 · Olympus - Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number:…
FDA Device · Class II · 2026-03-11 · Olympus - cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU,…
FDA Device · Class II · 2026-03-11 · Roche Diagnostics Operations - Impella RP Flex with SmartAssist
FDA Device · Class I · 2026-03-11 · Abiomed - Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device des…
FDA Device · Class II · 2026-03-11 · B Braun Medical - Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
FDA Device · Class II · 2026-03-11 · Advanced Bionics - Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number:…
FDA Device · Class II · 2026-03-11 · Olympus - Impella RP. Product Code: 0046-0011
FDA Device · Class I · 2026-03-11 · Abiomed - Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
FDA Device · Class II · 2026-03-04 · Medline Industries - Campy CVA Medium 100/PK, R01272
FDA Device · Class II · 2026-03-04 · Remel - Olympus Resection Inner Sheath for 26 Fr. Outer Sheath
FDA Device · Class II · 2026-03-04 · Olympus - Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt A…
FDA Device · Class II · 2026-03-04 · Agiliti Health Ellis - Olympus Resection Sheath, 8 mm
FDA Device · Class II · 2026-03-04 · Olympus - Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19…
FDA Device · Class II · 2026-03-04 · Medline Industries - Olympus Inner Sheath
FDA Device · Class II · 2026-03-04 · Olympus - PIE Trolley System Model: 2005
FDA Device · Class II · 2026-03-04 · Edermy - Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications
FDA Device · Class II · 2026-03-04 · Olympus - PIE PAK Models: P2HC-A, P2HC-S, P2HC
FDA Device · Class II · 2026-03-04 · Edermy - Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 5…
FDA Device · Class II · 2026-03-04 · Encore Medical - Olympus Cystoscope Outer Sheath
FDA Device · Class II · 2026-03-04 · Olympus - Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A
FDA Device · Class II · 2026-03-04 · Medline Industries - Olympus Inner Sheath, Long
FDA Device · Class II · 2026-03-04 · Olympus - Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
FDA Device · Class II · 2026-03-04 · Medline Industries - Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
FDA Device · Class II · 2026-03-04 · Hitachi Radiation Oncology Systems Kashiwanoha - MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam L…
FDA Device · Class II · 2026-03-04 · Mrimed - Olympus Resection Sheath, 28 Fr
FDA Device · Class II · 2026-03-04 · Olympus - Olympus Resection Sheath, 28 Fr. with Deflecting Obturator
FDA Device · Class II · 2026-03-04 · Olympus - Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00…
FDA Device · Class II · 2026-03-04 · Encore Medical - Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
FDA Device · Class II · 2026-03-04 · Encore Medical - Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath
FDA Device · Class II · 2026-03-04 · Olympus - Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI110…
FDA Device · Class II · 2026-03-04 · Medline Industries - Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
FDA Device · Class II · 2026-03-04 · Medline Industries - Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
FDA Device · Class II · 2026-03-04 · Medline Industries - Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRA…
FDA Device · Class II · 2026-03-04 · Medline Industries - Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
FDA Device · Class II · 2026-03-04 · Hitachi Radiation Oncology Systems Kashiwanoha - Olympus Resection Sheath, 26 Fr
FDA Device · Class II · 2026-03-04 · Olympus - Olympus Resection Sheath, 24 Fr
FDA Device · Class II · 2026-03-04 · Olympus - Olympus Inner Sheath, Long
FDA Device · Class II · 2026-03-04 · Olympus - Olympus Resection Sheath
FDA Device · Class II · 2026-03-04 · Olympus - Olympus Inner Sheath
FDA Device · Class II · 2026-03-04 · Olympus - Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
FDA Device · Class II · 2026-03-04 · Medtronic Perfusion Systems - Olympus Inner Sheath
FDA Device · Class II · 2026-03-04 · Olympus - Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND…
FDA Device · Class II · 2026-03-04 · Medline Industries - Olympus Resection Sheath, 26 Fr. with Deflecting Obturator
FDA Device · Class II · 2026-03-04 · Olympus - Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
FDA Device · Class II · 2026-03-04 · Medline Industries - Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications
FDA Device · Class II · 2026-03-04 · Olympus - Olympus Resection Sheath, 24 Fr., with Deflecting Obturator
FDA Device · Class II · 2026-03-04 · Olympus - Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
FDA Device · Class II · 2026-03-04 · Medline Industries - Olympus Resection Sheath
FDA Device · Class II · 2026-03-04 · Olympus - Olympus Resection Sheath
FDA Device · Class II · 2026-03-04 · Olympus - Olympus Inner Sheath
FDA Device · Class II · 2026-03-04 · Olympus - Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G
FDA Device · Class II · 2026-02-25 · Medline Industries - Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
FDA Device · Class II · 2026-02-25 · Olympus - Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326
FDA Device · Class II · 2026-02-25 · Medline Industries - MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045
FDA Device · Class II · 2026-02-25 · Integra Lifesciences Neurosciences
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)