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.
- Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem…
FDA Device · Class II · 2025-10-29 · Cardinal Health 200 - Elscint SPX6
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended f…
FDA Device · Class III · 2025-10-29 · Home Health Us - GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5
FDA Device · Class II · 2025-10-29 · Wipro Ge Healthcare Private - Fuse ULTRA Foot Plating System Instructions for Use
FDA Device · Class II · 2025-10-29 · Cpm Medical Consultants - DxI 9000 Access Immunoassay Analyzer, Part Number C11137
FDA Device · Class II · 2025-10-29 · Beckman Coulter - BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrumen…
FDA Device · Class II · 2025-10-29 · Becton Dickinson And - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Shanghai United Imaging Healthcare Co., Ltd
FDA Device · Class II · 2025-10-29 · Uih Technologies - Elscint Cardial
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - Starcam/Camstar
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359
FDA Device · Class I · 2025-10-29 · Icu Medical - LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing…
FDA Device · Class II · 2025-10-29 · Synthes Usa Products - GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03
FDA Device · Class II · 2025-10-29 · Wipro Ge Healthcare Private - Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - MobileDiagnost wDR 2.2
FDA Device · Class II · 2025-10-29 · Sedecal - Sedecal Mobile Digital Diagnostic X-Ray Systems
FDA Device · Class II · 2025-10-29 · Sedecal - Elscint Varicam
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE…
FDA Device · Class II · 2025-10-29 · Cardinal Health 200 - Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
FDA Device · Class II · 2025-10-29 · Cardinal Health 200 - Millenium Myosight
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - Elscint Model 4XX
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers…
FDA Device · Class II · 2025-10-29 · Baxter Healthcare - Model Number 40KWFXPLUS-710CW, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - Model SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240
FDA Device · Class II · 2025-10-29 · Medline Industries - Model Number 40KWFXPLUS.002, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Ass…
FDA Device · Class II · 2025-10-29 · Theken Companies - t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when…
FDA Device · Class II · 2025-10-29 · Tandem Diabetes Care - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Millenium MPR
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609,…
FDA Device · Class II · 2025-10-29 · Becton Dickinson And - HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
FDA Device · Class II · 2025-10-29 · Heartsine Technologies - Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - Zenition 50
FDA Device · Class II · 2025-10-29 · Philips Medical Systems Nederland B V - Shanghai United Imaging Healthcare Co., Ltd
FDA Device · Class II · 2025-10-29 · Uih Technologies - Model Number 40KWMOBILE3.899, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Shanghai United Imaging Healthcare Co., Ltd
FDA Device · Class II · 2025-10-29 · Uih Technologies - Model SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - SM_40HF_B_D_VIR3.004, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - SM_40HF_B_D_VIR3, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 2661…
FDA Device · Class II · 2025-10-29 · Cardinal Health 200 - Millenium MG/MC
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - SHIMADZU RF.004, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - SM_40HF_BDC3, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number 40KWFXPLUS.889, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - Shanghai United Imaging Healthcare Co., Ltd
FDA Device · Class II · 2025-10-29 · Uih Technologies - BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. CO…
FDA Device · Class II · 2025-10-29 · Becton Dickinson And - Shanghai United Imaging Healthcare Co., Ltd
FDA Device · Class II · 2025-10-29 · Uih Technologies - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Artegraft¿ Collagen Vascular Graft
FDA Device · Class II · 2025-10-29 · Lemaitre Vascular - Millenium MPS
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - Model Number 40KWFXPLUS, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach…
FDA Device · Class II · 2025-10-29 · Cardinal Health 200 - SED URS LP, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - Shanghai United Imaging Healthcare Co., Ltd
FDA Device · Class II · 2025-10-29 · Uih Technologies - Optima NX
FDA Device · Class II · 2025-10-29 · Ge Medical Systems Israel Functional Imaging - RADPRO MOBILE, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version:…
FDA Device · Class I · 2025-10-29 · B Braun Medical - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number SM-40HF-B-D-C
FDA Device · Class II · 2025-10-29 · Sedecal - Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
FDA Device · Class II · 2025-10-29 · Sedecal - CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM I…
FDA Device · Class II · 2025-10-22 · American Contract Systems - TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F
FDA Device · Class I · 2025-10-22 · Abbott - Product: STA Liatest D-Di
FDA Device · Class II · 2025-10-22 · Diagnostica Stago - Model Number L110, ESSENTIO SR SL MRI Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF
FDA Device · Class I · 2025-10-22 · Abbott - Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
FDA Device · Class II · 2025-10-22 · American Contract Systems - The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field u…
FDA Device · Class II · 2025-10-22 · Insulet - FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816
FDA Device · Class II · 2025-10-22 · Ferno Washington - Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRT…
FDA Device · Class II · 2025-10-22 · American Contract Systems - CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35…
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
FDA Device · Class I · 2025-10-22 · Olympus - CX Preconnect with TENACIO Pump with InhibiZone
FDA Device · Class II · 2025-10-22 · Boston Scientific - Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED35…
FDA Device · Class II · 2025-10-22 · Microvention - TENACIO Pump without InhibiZone
FDA Device · Class II · 2025-10-22 · Boston Scientific - BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
FDA Device · Class I · 2025-10-22 · Olympus - Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DEL…
FDA Device · Class II · 2025-10-22 · American Contract Systems - Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 met…
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - ACCOLADE DR EL (Model L321)
FDA Device · Class I · 2025-10-22 · Boston Scientific - XERF EFFECTOR 60
FDA Device · Class II · 2025-10-22 · Lutronic - Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C A…
FDA Device · Class II · 2025-10-22 · American Contract Systems - Model Number U125, VALITUDE CRT-P EL
FDA Device · Class I · 2025-10-22 · Boston Scientific - CX Preconnect with TENACIO Pump without InhibiZone
FDA Device · Class II · 2025-10-22 · Boston Scientific - Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK…
FDA Device · Class II · 2025-10-22 · American Contract Systems - CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (2…
FDA Device · Class II · 2025-10-22 · Baxter Healthcare - Cardiac Workstation 7000
FDA Device · Class II · 2025-10-22 · Philips North America - EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
FDA Device · Class I · 2025-10-22 · Olympus - Cyclopen Microinterventional Cyclodialysis System
FDA Device · Class II · 2025-10-22 · Iantrek - Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number L221 PROPONENT DR EL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific
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)