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.
- BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
FDA Device · Class II · 2025-12-17 · C R Bard - Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L,…
FDA Device · Class III · 2025-12-17 · Orthofix U S - Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L…
FDA Device · Class III · 2025-12-17 · Orthofix U S - ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile
FDA Device · Class II · 2025-12-17 · Cardinal Health 200 - Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W…
FDA Device · Class III · 2025-12-17 · Orthofix U S - Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QS
FDA Device · Class II · 2025-12-17 · Medline Industries - Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12
FDA Device · Class II · 2025-12-17 · Waldemar Link And Kg Mfg Site - Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25600QS
FDA Device · Class II · 2025-12-17 · Medline Industries - Cardiosave Hybrid
FDA Device · Class II · 2025-12-17 · Datascope - ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the pa…
FDA Device · Class I · 2025-12-17 · Draeger - Cardiosave Rescue
FDA Device · Class II · 2025-12-17 · Datascope - Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
FDA Device · Class II · 2025-12-17 · Medline Industries - ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the pati…
FDA Device · Class I · 2025-12-17 · Draeger - Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
FDA Device · Class II · 2025-12-17 · C R Bard - Stryker Arise 1000EX mattress, Part Number 2236000000
FDA Device · Class II · 2025-12-17 · Stryker Medical Division - AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use i…
FDA Device · Class II · 2025-12-17 · Steris - BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
FDA Device · Class II · 2025-12-17 · C R Bard - Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
FDA Device · Class II · 2025-12-17 · Ge Medical Systems - Fructose Intolerance Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Food Sensitivity Test Large
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue MP2. Product Number: M8102A
FDA Device · Class II · 2025-12-10 · Philips North America - Vaginal PH Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Melatonin Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Ivenix Infusion System (IIS), Large Volume Pump
FDA Device · Class II · 2025-12-10 · Fresenius Kabi Usa - Food Sensitivity Test Medium
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - 2 in 1 Trichomonas / Gardnerella Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue Patient Monitor MX550
FDA Device · Class II · 2025-12-10 · Philips North America - Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Parasite Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue MP70
FDA Device · Class II · 2025-12-10 · Philips North America - IntelliVue MP80
FDA Device · Class II · 2025-12-10 · Philips North America - Neurotransmitters Plus
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - MAMMOMAT Fusion
FDA Device · Class II · 2025-12-10 · Siemens Medical Solutions Usa - Environmental Pollutants Profile Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Allergy Test IgE
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Food Allergy Panel Test (IgE)
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue Patient Monitor MX400
FDA Device · Class II · 2025-12-10 · Philips North America - Diabetes Test (ketones & glucose)
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue Patient Monitor MX450
FDA Device · Class II · 2025-12-10 · Philips North America - Peptic Ulcer Test (H, pylori)
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Gut Microbiome Test XL
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - SIBO Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Alcohol (ALC) Test Saliva
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Cholesterol Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Pet Allergy Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Kidney Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Incisive CT
FDA Device · Class II · 2025-12-10 · Philips North America - KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
FDA Device · Class II · 2025-12-10 · Microbiologics - MPOX Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Olympus OER-Pro
FDA Device · Class II · 2025-12-10 · Aizu Olympus - HPV Antigen Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Sorbitol Intolerance Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Iron Deficiency Test (ferritin)
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - PSA Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Olympus OER-Elite
FDA Device · Class II · 2025-12-10 · Aizu Olympus - NAD Profile Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Lactose Intolerance Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Drug Test Small (4 substances)
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Gut Microbiome Test Mega
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Akkermansia Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25)
FDA Device · Class I · 2025-12-10 · Fresenius Kabi Usa - Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagu…
FDA Device · Class II · 2025-12-10 · Accriva Diagnostics - IntelliVue MP30
FDA Device · Class II · 2025-12-10 · Philips North America - Blood Type Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue MP50
FDA Device · Class II · 2025-12-10 · Philips North America - Organic Acids Profile Test Large
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Food Intolerance Test Large
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
FDA Device · Class II · 2025-12-10 · Paragon 28 - Neurotransmitters Basic
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Fecal Occult Blood Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Biological Age & Longevity Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18
FDA Device · Class II · 2025-12-10 · Baxter Healthcare - MAMMOMAT Inspiration
FDA Device · Class II · 2025-12-10 · Siemens Medical Solutions Usa - Food Intolerance Test Small
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Lyme Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841
FDA Device · Class II · 2025-12-10 · Philips Ultrasound - Vitamin D-Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Pollen Allergy Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue Patient Monitor MX500
FDA Device · Class II · 2025-12-10 · Philips North America - Estrogen & Progesterone Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Allergy test Small
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Women s Hormone Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Gut Microbiome Test Medium
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Candida Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Urinary Tract Infection Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue Multi Measurement Server X2. Product Number: M3002A
FDA Device · Class II · 2025-12-10 · Philips North America - Food Intolerance Test Medium
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Candida Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IntelliVue Patient Monitor MX800
FDA Device · Class II · 2025-12-10 · Philips North America - IntelliVue MP5. Product Number: M8105A
FDA Device · Class II · 2025-12-10 · Philips North America - Mycoplasma test, IgG and IgM
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Gut Microbiome Test Small
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Heavy Metals Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Allergy test Small
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Herpes (HSV-1 & HSV-2) Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Olympus OER-Mini
FDA Device · Class II · 2025-12-10 · Aizu Olympus - GI Microbiome Profile Small
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - Neurotransmitters XL
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - GI Microbiome Profile XL
FDA Device · Class II · 2025-12-10 · Get Tested International Ab - IBS Test
FDA Device · Class II · 2025-12-10 · Get Tested International Ab
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)