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.
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
FDA Device · Class I · 2025-10-22 · Olympus - BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
FDA Device · Class I · 2025-10-22 · Olympus - Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
FDA Device · Class II · 2025-10-22 · American Contract Systems - Model Number L100, ESSENTIO SR SL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number U225 VISIONIST CRT-P EL
FDA Device · Class I · 2025-10-22 · Boston Scientific - C-Rex UNO Microinterventional Goniotomy Instrument
FDA Device · Class II · 2025-10-22 · Iantrek - CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL…
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - PROPONENT SR SL (Model L200)
FDA Device · Class I · 2025-10-22 · Boston Scientific - EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
FDA Device · Class I · 2025-10-22 · Olympus - CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK…
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - Model Number S701 ALTRUA 2 SR SL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPL…
FDA Device · Class II · 2025-10-22 · American Contract Systems - BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
FDA Device · Class I · 2025-10-22 · Olympus - Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
FDA Device · Class II · 2025-10-22 · American Contract Systems - BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERA…
FDA Device · Class II · 2025-10-22 · Biopro - OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
FDA Device · Class I · 2025-10-22 · Olympus - CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops…
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - PROPONENT DR SL (Model L201)
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number U226, VISIONIST CRT-P EL
FDA Device · Class I · 2025-10-22 · Boston Scientific - ACCOLADE DR SL (Model L301)
FDA Device · Class I · 2025-10-22 · Boston Scientific - CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters)
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
FDA Device · Class I · 2025-10-22 · Olympus - BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
FDA Device · Class I · 2025-10-22 · Olympus - Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 S…
FDA Device · Class II · 2025-10-22 · American Contract Systems - Medline Adult Anesthesia Set, REF DYNJ39985G
FDA Device · Class II · 2025-10-22 · Medline Industries - Model Number U228, VISIONIST CRT-P EL MRI
FDA Device · Class I · 2025-10-22 · Boston Scientific - BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10…
FDA Device · Class II · 2025-10-22 · Biopro - Model Number L209 PROPONENT DR (VDD) SL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
FDA Device · Class I · 2025-10-22 · Olympus - CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/…
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
FDA Device · Class I · 2025-10-22 · Olympus - Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - TENACIO Pump with InhibiZone
FDA Device · Class II · 2025-10-22 · Boston Scientific - Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.…
FDA Device · Class II · 2025-10-22 · Kico Knee Innovation - ACCOLADE SR SL MRI (Model L310)
FDA Device · Class I · 2025-10-22 · Boston Scientific - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare - EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
FDA Device · Class I · 2025-10-22 · Olympus - ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
FDA Device · Class II · 2025-10-22 · Ethicon Endo Surgery - ACCOLADE DR SL MRI (Model L311)
FDA Device · Class I · 2025-10-22 · Boston Scientific - Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY1…
FDA Device · Class II · 2025-10-22 · American Contract Systems - Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-…
FDA Device · Class I · 2025-10-22 · Cook Medical - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare - TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D
FDA Device · Class I · 2025-10-22 · Abbott - Basic Biopsy Tray, Item Number NMBP44L
FDA Device · Class II · 2025-10-22 · American Contract Systems - Cardiac Workstation 5000
FDA Device · Class II · 2025-10-22 · Philips North America - BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD…
FDA Device · Class II · 2025-10-22 · Biopro - Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CAR…
FDA Device · Class II · 2025-10-22 · American Contract Systems - Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve…
FDA Device · Class I · 2025-10-22 · Percussionaire - BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
FDA Device · Class I · 2025-10-22 · Olympus - TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ
FDA Device · Class I · 2025-10-22 · Abbott - Model Number U128, VALITUDE CRT-P EL MRI
FDA Device · Class I · 2025-10-22 · Boston Scientific - LGX Preconnect with TENACIO Pump without InhibiZone
FDA Device · Class II · 2025-10-22 · Boston Scientific - CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (11…
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-07…
FDA Device · Class II · 2025-10-22 · Contego Medical - OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
FDA Device · Class I · 2025-10-22 · Olympus - EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
FDA Device · Class I · 2025-10-22 · Olympus - OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
FDA Device · Class I · 2025-10-22 · Olympus - CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEA…
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
FDA Device · Class I · 2025-10-22 · Olympus - LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
FDA Device · Class II · 2025-10-22 · Ge Medical Systems - EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
FDA Device · Class I · 2025-10-22 · Olympus - Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
FDA Device · Class II · 2025-10-22 · Fisher And Paykel Healthcare - LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
FDA Device · Class II · 2025-10-22 · Ge Medical Systems - BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
FDA Device · Class I · 2025-10-22 · Olympus - TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD
FDA Device · Class I · 2025-10-22 · Abbott - CXR Preconnect with TENACIO Pump with InhibiZone
FDA Device · Class II · 2025-10-22 · Boston Scientific - CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - ACCOLADE SR SL (Model L300)
FDA Device · Class I · 2025-10-22 · Boston Scientific - EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
FDA Device · Class I · 2025-10-22 · Olympus - Model Number S702, ALTRUA 2 DR SL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Medical convenience kits IHDC30R D AND C PACK
FDA Device · Class II · 2025-10-22 · American Contract Systems - EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
FDA Device · Class I · 2025-10-22 · Olympus - Model Number S722, ALTRUA 2 DR EL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - LOGIQ P10 series with software version R4.5.7 Model Number 5877534
FDA Device · Class II · 2025-10-22 · Ge Medical Systems - Model Number L210 PROPONENT SR SL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - LGX Preconnect with TENACIO Pump with InhibiZone
FDA Device · Class II · 2025-10-22 · Boston Scientific - BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD F…
FDA Device · Class II · 2025-10-22 · Biopro - CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19…
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM…
FDA Device · Class II · 2025-10-22 · Biopro - EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
FDA Device · Class I · 2025-10-22 · Olympus - ACCOLADE DR EL MRI (Model L331)
FDA Device · Class I · 2025-10-22 · Boston Scientific - Basic Biopsy Tray
FDA Device · Class II · 2025-10-22 · American Contract Systems - Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212…
FDA Device · Class II · 2025-10-22 · American Contract Systems - Model Number L101, ESSENTIO DR SL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare - Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
FDA Device · Class II · 2025-10-22 · American Contract Systems - DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds
FDA Device · Class II · 2025-10-22 · Convatec - CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 m…
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 1902…
FDA Device · Class II · 2025-10-22 · Biopro - Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37…
FDA Device · Class II · 2025-10-22 · American Contract Systems - Model Number L121 ESSENTIO DR EL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops…
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - FlexLab (FLX) System
FDA Device · Class II · 2025-10-15 · Inpeco - PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound…
FDA Device · Class II · 2025-10-15 · B Braun Medical - EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
FDA Device · Class II · 2025-10-15 · Corneat Vision - CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
FDA Device · Class II · 2025-10-15 · Corneat Vision - This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration
FDA Device · Class II · 2025-10-15 · Canon Medical System Usa - Artegraft Collagen Vascular Graft
FDA Device · Class II · 2025-10-15 · Lemaitre Vascular
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)