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.
- Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
FDA Device · Class II · 2025-12-10 · Medtronic - Pregnancy Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Gut Microbiome Test Large
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue Patient Monitor MX850
FDA Device · Class II · 2025-12-10 · Philips North America - Men s Hormone Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue Patient Monitor MX700
FDA Device · Class II · 2025-12-10 · Philips North America - Liver Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - InSure ONE Fecal Immunochemical Test
FDA Device · Class II · 2025-12-10 · Enterix - Thyroid TSH Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Food Sensitivity Test Small
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - 8 in 1 STI Test Kit
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Mycotoxin Panel Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Continuous Glucose Monitor (CGM)
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Serotonin Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Vitamin D2 and D3 Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Leaky Gut Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Sperm Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Iodine Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - 3 in 1 STI Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue MP20
FDA Device · Class II · 2025-12-10 · Philips North America - Syphilis Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - H pylori (Peptic ulcer) Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Iron Deficiency Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Menopause (FSH) 2 Tests
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Diabetes HbA1c Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, RE…
FDA Device · Class II · 2025-12-10 · Illumina - Intestinal Worms Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Illegally Marketed
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Allergy & Food Intolerance Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Ovulation Test (5 tests)
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Trichomonas Vaginalis test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - DHEA Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue MP60
FDA Device · Class II · 2025-12-10 · Philips North America - Sperm Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Hair Mineral Analysis
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue Patient Monitor MX100
FDA Device · Class II · 2025-12-10 · Philips North America - Female Fertility Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Organic acids Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue Patient Monitor MX750
FDA Device · Class II · 2025-12-10 · Philips North America - Chlamydia Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - D-Dimer Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue Patient Monitor MX600
FDA Device · Class II · 2025-12-10 · Philips North America - Parasite Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue MP40
FDA Device · Class II · 2025-12-10 · Philips North America - IntelliVue Multi-Measurement Module X3. Product Number: 867030
FDA Device · Class II · 2025-12-10 · Philips North America - Adrenal Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - MAMMOMAT Revelation
FDA Device · Class II · 2025-12-10 · Siemens Medical Solutions Usa - IntelliVue MP90
FDA Device · Class II · 2025-12-10 · Philips North America - CT 5300
FDA Device · Class II · 2025-12-10 · Philips North America - Gonorrhea test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - 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 - 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 - SAFELINE 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 - Vista set 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 - 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 - Philips Azurion 7M20 systems with FlexArm ceiling-mounted system
FDA Device · Class II · 2025-12-03 · Philips Medical Systems Nederland B V - 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 - 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 - FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
FDA Device · Class II · 2025-12-03 · Foundation Medicine - 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 - DermaSensor
FDA Device · Class II · 2025-12-03 · Dermasensor - 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 - 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 - CareLink Clinic, REF: MMT-7350
FDA Device · Class II · 2025-12-03 · Medtronic Minimed - 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 - 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 - FoundationOne CDx (F1CDx), RAL-0003 version 31.0
FDA Device · Class II · 2025-12-03 · Foundation Medicine - 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 - 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 - 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 - BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
FDA Device · Class II · 2025-12-03 · Biofire Diagnostics - 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 - 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 - 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 - SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914
FDA Device · Class I · 2025-12-03 · Glycar - 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 - ULTRASITE 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 - 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 - CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093
FDA Device · Class II · 2025-12-03 · Alcon Research - 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 - 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 - The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood
FDA Device · Class II · 2025-12-03 · Magellan Diagnostics
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)