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.
- 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 - Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
FDA Device · Class II · 2026-02-25 · Medline Industries - Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
FDA Device · Class II · 2026-02-25 · Olympus - Olympus High Flow Insufflation Unit
FDA Device · Class I · 2026-02-25 · Olympus - Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B
FDA Device · Class II · 2026-02-25 · Medline Industries - Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump,…
FDA Device · Class II · 2026-02-25 · Baxter Healthcare - Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R
FDA Device · Class II · 2026-02-25 · Medline Industries - Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
FDA Device · Class II · 2026-02-25 · Olympus - Private Label CVS. Model Number: CVS405406
FDA Device · Class II · 2026-02-25 · Integra Lifesciences Neurosciences - Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
FDA Device · Class II · 2026-02-25 · Bard Peripheral Vascular - Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG
FDA Device · Class II · 2026-02-25 · Medline Industries - Estrone RIA, REF: DSL8700
FDA Device · Class II · 2026-02-25 · Immunotech A S - Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410
FDA Device · Class II · 2026-02-25 · Medline Industries - Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number:…
FDA Device · Class II · 2026-02-25 · Wilson Cook Medical - Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc r…
FDA Device · Class II · 2026-02-25 · Centinel Spine - Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G
FDA Device · Class II · 2026-02-25 · Medline Industries - Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
FDA Device · Class II · 2026-02-25 · Olympus - Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
FDA Device · Class II · 2026-02-25 · Medline Industries - Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55
FDA Device · Class II · 2026-02-25 · Medline Industries - Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
FDA Device · Class II · 2026-02-25 · Olympus - Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
FDA Device · Class II · 2026-02-25 · Olympus
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)