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.
- IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume…
FDA Device · Class II · 2025-12-03 · B Braun Medical - CARESAFE utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Ou…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Quantum Intersegmental Table, Model/Catalog Number: AMQ400H
FDA Device · Class II · 2025-12-03 · Pivotal Health Solutions - Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to…
FDA Device · Class I · 2025-12-03 · Olympus - SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510
FDA Device · Class I · 2025-12-03 · Glycar - Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, O…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum…
FDA Device · Class II · 2025-12-03 · B Braun Medical - ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Out…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IntelePACS - InteleConnect / TechPortal
FDA Device · Class II · 2025-12-03 · Intelerad Medical Systems - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum…
FDA Device · Class II · 2025-12-03 · B Braun Medical - SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System
FDA Device · Class II · 2025-12-03 · Mindray Ds Usa - NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP
FDA Device · Class II · 2025-12-03 · Stryker - Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its access…
FDA Device · Class II · 2025-12-03 · Noah Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System
FDA Device · Class II · 2025-12-03 · Mindray Ds Usa - Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Emdogain
FDA Device · Class II · 2025-12-03 · Straumann Usa - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
FDA Device · Class II · 2025-12-03 · Remel - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
FDA Device · Class II · 2025-12-03 · Djo - FlexLab (FLX)
FDA Device · Class II · 2025-12-03 · Inpeco - NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber
FDA Device · Class II · 2025-12-03 · Stryker - Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large…
FDA Device · Class II · 2025-12-03 · B Braun Medical - RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Out…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Quantum Intersegmental Table, Model/Catalog Number: Q400
FDA Device · Class II · 2025-12-03 · Pivotal Health Solutions - B.BRAUN utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Out…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of…
FDA Device · Class II · 2025-12-03 · Argon Medical Devices - Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pum…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This inst…
FDA Device · Class II · 2025-12-03 · Olympus - Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM…
FDA Device · Class II · 2025-12-03 · Medtronic Sofamor Danek Usa - Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10
FDA Device · Class II · 2025-12-03 · Cepheid - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Ou…
FDA Device · Class II · 2025-12-03 · B Braun Medical - FlexLab (FLX)
FDA Device · Class II · 2025-12-03 · Inpeco - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large…
FDA Device · Class II · 2025-12-03 · B Braun Medical - Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…
FDA Device · Class II · 2025-12-03 · B Braun Medical - NICO BrainPath
FDA Device · Class II · 2025-12-03 · Stryker - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Vo…
FDA Device · Class II · 2025-12-03 · B Braun Medical - DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagno…
FDA Device · Class II · 2025-11-26 · Beckman Coulter - SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L
FDA Device · Class II · 2025-11-26 · Asp Global - Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US
FDA Device · Class II · 2025-11-26 · Thoratec - MC3 VitalFlow Console, REF 58100
FDA Device · Class II · 2025-11-26 · Medtronic Perfusion Systems - MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D
FDA Device · Class II · 2025-11-26 · 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)