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.
- MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O
FDA Device · Class II · 2025-11-26 · Medline Industries - SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries
FDA Device · Class II · 2025-11-26 · Asp Global - MONARCH Bronchoscope
FDA Device · Class II · 2025-11-26 · Auris Health - Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
FDA Device · Class II · 2025-11-26 · Asp Global - SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcod…
FDA Device · Class II · 2025-11-26 · Cellavision Ab - MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
FDA Device · Class II · 2025-11-26 · Medline Industries - Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bo…
FDA Device · Class II · 2025-11-26 · Berkeley Advanced Biomaterials - Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product De…
FDA Device · Class II · 2025-11-26 · Exactech - SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K
FDA Device · Class II · 2025-11-26 · Medline Industries - MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V
FDA Device · Class II · 2025-11-26 · Medline Industries - SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C
FDA Device · Class II · 2025-11-26 · Medline Industries - MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W
FDA Device · Class II · 2025-11-26 · Medline Industries - Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Cathet…
FDA Device · Class II · 2025-11-26 · Olympus - SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYS…
FDA Device · Class II · 2025-11-26 · Sterilmed - SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Des…
FDA Device · Class II · 2025-11-26 · Exactech - Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Contro…
FDA Device · Class II · 2025-11-26 · Thoratec - SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUE…
FDA Device · Class II · 2025-11-26 · Greiner Bio One North America - Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US
FDA Device · Class II · 2025-11-26 · Thoratec - SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - BD Luer Tip Caps
FDA Device · Class II · 2025-11-26 · Becton Dickinson And - SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W
FDA Device · Class II · 2025-11-26 · Medline Industries - MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S
FDA Device · Class II · 2025-11-26 · Medline Industries - SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
FDA Device · Class II · 2025-11-26 · Meridian Bioscience - TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
FDA Device · Class I · 2025-11-26 · Tmj Solutions - Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
FDA Device · Class II · 2025-11-26 · Medtronic Perfusion Systems - MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026…
FDA Device · Class II · 2025-11-26 · Elekta Solutions Ab - SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
FDA Device · Class II · 2025-11-26 · Asp Global - Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version…
FDA Device · Class II · 2025-11-26 · Quest International - MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
FDA Device · Class II · 2025-11-26 · Medline Industries - BD Alaris infusion Pump Module 8100, REF: 8100
FDA Device · Class I · 2025-11-26 · Carefusion 303 - SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W
FDA Device · Class II · 2025-11-26 · Medline Industries - MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB
FDA Device · Class II · 2025-11-26 · Medline Industries - SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
FDA Device · Class III · 2025-11-26 · Polymedco Polymedco Cancer Diagnostic Products - MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
FDA Device · Class II · 2025-11-26 · Medline Industries - MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S
FDA Device · Class II · 2025-11-26 · Medline Industries - SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R
FDA Device · Class II · 2025-11-26 · Medline Industries - Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US
FDA Device · Class II · 2025-11-26 · Thoratec - SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800…
FDA Device · Class II · 2025-11-26 · Merit Medical Systems - Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTR…
FDA Device · Class II · 2025-11-26 · Sterilmed - MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L
FDA Device · Class II · 2025-11-26 · Medline Industries - MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G
FDA Device · Class II · 2025-11-26 · Medline Industries - MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F
FDA Device · Class II · 2025-11-26 · Medline Industries - Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product De…
FDA Device · Class II · 2025-11-26 · Exactech - Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
FDA Device · Class II · 2025-11-26 · Meridian Bioscience - SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
FDA Device · Class II · 2025-11-26 · Asp Global - AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P
FDA Device · Class II · 2025-11-26 · Medline Industries - MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
FDA Device · Class II · 2025-11-26 · Medline Industries - MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
FDA Device · Class II · 2025-11-26 · Medline Industries - Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING
FDA Device · Class I · 2025-11-19 · Medline Industries - Convenience kits
FDA Device · Class I · 2025-11-19 · Medline Industries - VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the la…
FDA Device · Class III · 2025-11-19 · Accriva Diagnostics - Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15 or lower
FDA Device · Class II · 2025-11-19 · Medline Industries - Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
FDA Device · Class II · 2025-11-19 · Abbott Medical - Precision CRF
FDA Device · Class II · 2025-11-19 · Philips Medical Systems Dmc - Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System
FDA Device · Class II · 2025-11-19 · Orthofix U S - Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
FDA Device · Class II · 2025-11-19 · Ge Healthcare Finland Oy - Food Panel 3 Specific Allergen
FDA Device · Class II · 2025-11-19 · Siemens Healthcare Diagnostics - GM85 Digital Mobile X-ray imaging System
FDA Device · Class II · 2025-11-19 · Neurologica - Convenience Kit, BREAST HERNIA DYNJ909125G
FDA Device · Class I · 2025-11-19 · Medline Industries - Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower
FDA Device · Class II · 2025-11-19 · Medline Industries - Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits
FDA Device · Class I · 2025-11-19 · Medline Industries - Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Proced…
FDA Device · Class II · 2025-11-19 · Sonesta Medical Ab - Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower
FDA Device · Class II · 2025-11-19 · Medline Industries - Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits
FDA Device · Class I · 2025-11-19 · Medline Industries - Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits
FDA Device · Class I · 2025-11-19 · Medline Industries - Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision…
FDA Device · Class II · 2025-11-19 · Techno Path Manufacturing - CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305…
FDA Device · Class I · 2025-11-19 · Cerenovus - Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
FDA Device · Class II · 2025-11-19 · Applied Medical Technology - MAGNETOM Cima.X Upgrade
FDA Device · Class I · 2025-11-19 · Siemens Medical Solutions Usa - Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits
FDA Device · Class I · 2025-11-19 · Medline Industries - Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
FDA Device · Class II · 2025-11-19 · Medtronic Perfusion Systems - Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I
FDA Device · Class II · 2025-11-19 · Applied Medical Technology - Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW Version 4.0.1.15 or lower
FDA Device · Class II · 2025-11-19 · Medline Industries - Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05090-I
FDA Device · Class II · 2025-11-19 · Applied Medical Technology - DigitalDiagnost 4 (1) High Performance, (2) Flex/Value
FDA Device · Class II · 2025-11-19 · Philips Medical Systems Dmc - DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER
FDA Device · Class II · 2025-11-19 · Philips Medical Systems Dmc - Convenience kits
FDA Device · Class I · 2025-11-19 · Medline Industries - CombiDiagnost R90
FDA Device · Class II · 2025-11-19 · Philips Medical Systems Dmc - Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
FDA Device · Class II · 2025-11-19 · Abbott Medical - IMMULITE 2000 Oak Mix Specific Allergen
FDA Device · Class II · 2025-11-19 · Siemens Healthcare Diagnostics - Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm 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 with FT10 Generator 44 cm FT10 SW Version 4.0.1.15 or lower
FDA Device · Class II · 2025-11-19 · Medline Industries
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)