FDA Device · 2025
FDA Device recalls in 2025
RecallRadar indexes 2,908 FDA Device recall notices published in 2025. By classification: 380 Class I, 2,433 Class II, 95 Class III.
- CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor,…
FDA Device · Class II · 2025-11-19 · Ge Healthcare Finland Oy - Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the pre…
FDA Device · Class II · 2025-11-19 · Techno Path Manufacturing - Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I
FDA Device · Class II · 2025-11-19 · Applied Medical Technology - Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 or lower
FDA Device · Class II · 2025-11-19 · Medline Industries - Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.15 or lower
FDA Device · Class II · 2025-11-19 · Medline Industries - Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or lower
FDA Device · Class II · 2025-11-19 · Medline Industries - Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Cata…
FDA Device · Class II · 2025-11-19 · Olympus - Radiography 7300 C
FDA Device · Class II · 2025-11-19 · Philips Medical Systems Dmc - BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, r…
FDA Device · Class II · 2025-11-19 · Ge Healthcare Finland Oy - DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
FDA Device · Class I · 2025-11-19 · Medline Industries - Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The S…
FDA Device · Class II · 2025-11-19 · Olympus - ProxiDiagnost N90
FDA Device · Class II · 2025-11-19 · Philips Medical Systems Dmc - BEAR Implant (Bridge-Enhanced ACL Restoration)
FDA Device · Class II · 2025-11-19 · Miach Orthopaedics - B105P, B125P, B105M, B125M, B155M Patient Monitors
FDA Device · Class II · 2025-11-19 · Ge Healthcare Finland Oy - Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I
FDA Device · Class II · 2025-11-19 · Applied Medical Technology - 3gAllergy Specific IgE Universal Kit
FDA Device · Class II · 2025-11-19 · Siemens Healthcare Diagnostics - Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray t…
FDA Device · Class II · 2025-11-19 · Shimadzu Medical Systems Division - Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin)
FDA Device · Class II · 2025-11-19 · Covidien - SimplyGo Mini, Standard Battery Kit
FDA Device · Class II · 2025-11-19 · Philips Respironics - BD Kiestra" Isolate Suspension Cuvette Array
FDA Device · Class II · 2025-11-19 · Becton Dickinson And - Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10…
FDA Device · Class II · 2025-11-19 · Olympus - Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower
FDA Device · Class II · 2025-11-19 · Medline Industries - Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, FT10 SW Version 4.0.1.15 or lower
FDA Device · Class II · 2025-11-19 · Medline Industries - Anesthesia circuit kit
FDA Device · Class I · 2025-11-19 · Medline Industries - HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
FDA Device · Class II · 2025-11-19 · Stryker Sustainability Solutions - Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin)
FDA Device · Class II · 2025-11-19 · Covidien - Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5…
FDA Device · Class II · 2025-11-19 · Abbott Laboratories - Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Ph…
FDA Device · Class II · 2025-11-19 · Ge Healthcare Finland Oy - bk3000 Ultrasound System w/battery
FDA Device · Class II · 2025-11-12 · B K Medical A S - Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 11003…
FDA Device · Class II · 2025-11-12 · Zimmer - MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm
FDA Device · Class II · 2025-11-12 · Mozarc Medical Us - MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm
FDA Device · Class II · 2025-11-12 · Mozarc Medical Us - Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology In…
FDA Device · Class II · 2025-11-12 · Spacelabs Healthcare - bk3500 Ultrasound System w/battery
FDA Device · Class II · 2025-11-12 · B K Medical A S - Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The In…
FDA Device · Class II · 2025-11-12 · Elekta - MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm
FDA Device · Class II · 2025-11-12 · Mozarc Medical Us - TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01
FDA Device · Class II · 2025-11-12 · Integra Lifesciences Neurosciences - Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 7…
FDA Device · Class II · 2025-11-12 · Prismatik Dentalcraft - MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm
FDA Device · Class II · 2025-11-12 · Mozarc Medical Us - CODMAN Disposable Perforator 9mm
FDA Device · Class I · 2025-11-12 · Integra Lifesciences Neurosciences - Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS
FDA Device · Class II · 2025-11-12 · Osstem Implant - UUltrasound System 2300, bkActiv w/battery
FDA Device · Class II · 2025-11-12 · B K Medical A S - MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm
FDA Device · Class II · 2025-11-12 · Mozarc Medical Us - Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 11003…
FDA Device · Class II · 2025-11-12 · Zimmer - Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260
FDA Device · Class II · 2025-11-12 · Beckman Coulter - MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm
FDA Device · Class II · 2025-11-12 · Mozarc Medical Us - Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS
FDA Device · Class II · 2025-11-12 · Osstem Implant - CODMAN Disposable Perforator 11mm
FDA Device · Class I · 2025-11-12 · Integra Lifesciences Neurosciences - Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head
FDA Device · Class II · 2025-11-12 · Total Joint Orthopedics - Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456
FDA Device · Class II · 2025-11-12 · Beckman Coulter - Ultrasound System 1300, bkSpecto w/battery
FDA Device · Class II · 2025-11-12 · B K Medical A S - Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus del…
FDA Device · Class I · 2025-11-12 · Tandem Diabetes Care - 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500…
FDA Device · Class II · 2025-11-12 · B K Medical A S - Osstem Dental X-Ray System T2Plus
FDA Device · Class II · 2025-11-12 · Osstem Implant - bk5000 Ultrasound System w/battery
FDA Device · Class II · 2025-11-12 · B K Medical A S - SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
FDA Device · Class II · 2025-11-12 · Beckman Coulter - Regular Flow Bundle
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Desc…
FDA Device · Class II · 2025-11-05 · Aesculap - Initiation 36 Coated Regular Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Ivenix Infusion System (IIS), Large Volume Pump
FDA Device · Class II · 2025-11-05 · Fresenius Kabi Usa - Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
FDA Device · Class II · 2025-11-05 · Surgical Theater - Initiation 3 Month Trial Tampon Box
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011
FDA Device · Class II · 2025-11-05 · Asp Global - Refill 18 Coated Regular and 18 Coated Super Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Refill 3 Month Heavy Flow Bundle
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
FDA Device · Class II · 2025-11-05 · Icu Medical - Initiation 18 Coated Super and 18 Nude Super Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Refill 3 Month Trial Tampon Box
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp,…
FDA Device · Class II · 2025-11-05 · Icu Medical - Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit
FDA Device · Class II · 2025-11-05 · Cepheid - Initiation 3 Month All in One Bundle
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
FDA Device · Class I · 2025-11-05 · Impris Imaging - Brand Name: Alcon Laboratories, Inc
FDA Device · Class II · 2025-11-05 · Alcon Research - Brand Name: Alcon Laboratories, Inc
FDA Device · Class II · 2025-11-05 · Alcon Research - Initiation 3 Month Heavy Flow Bundle
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - All in One Bundle
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - ChemoLock Bag Spike, 01 units REF: CL-10-10
FDA Device · Class II · 2025-11-05 · Icu Medical - SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological…
FDA Device · Class II · 2025-11-05 · Surgical Theater - Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter
FDA Device · Class II · 2025-11-05 · Trividia Health - ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
FDA Device · Class II · 2025-11-05 · Icu Medical - Heavy Flow Bundle
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Bag Spike REF: CL-10
FDA Device · Class II · 2025-11-05 · Icu Medical - Assay: IMMULITE 2000 Intact PTH
FDA Device · Class II · 2025-11-05 · Siemens Healthcare Diagnostics - CellMek SPS Sample Preparation System, REF: C44603
FDA Device · Class II · 2025-11-05 · Beckman Coulter - ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
FDA Device · Class II · 2025-11-05 · Icu Medical - Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
FDA Device · Class II · 2025-11-05 · Surgical Theater - SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
FDA Device · Class II · 2025-11-05 · Surgical Theater - Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11…
FDA Device · Class I · 2025-11-05 · Dexcom - MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
FDA Device · Class II · 2025-11-05 · Microsurgical Technology - ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
FDA Device · Class II · 2025-11-05 · Icu Medical - VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7
FDA Device · Class II · 2025-11-05 · Canon Medical System Usa - ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
FDA Device · Class II · 2025-11-05 · Icu Medical - Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, O…
FDA Device · Class II · 2025-11-05 · Microgenics - 9 Coated Super Tampons and 9 Nude Super Tampons
FDA Device · Class II · 2025-11-05 · Daye Anne S Day - Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description:…
FDA Device · Class II · 2025-11-05 · Aesculap
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)