Browse Device Recalls
38,509 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,509 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 38,509 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 6, 2025 | BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit ... | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Nov 6, 2025 | Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Nov 6, 2025 | MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) | Following a component change in the DPOAE probe (speaker replacement), technical distortions may ... | Class II | PATH |
| Nov 6, 2025 | BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit R... | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Nov 5, 2025 | Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for B... | Safety and efficacy of dialysis acid concentrate cannot be assured | Class II | Diasol, Inc |
| Nov 5, 2025 | Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for B... | Safety and efficacy of dialysis acid concentrate cannot be assured | Class II | Diasol, Inc |
| Nov 5, 2025 | Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be ... | Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign obje... | Class II | Accriva Diagnostics, Inc. |
| Nov 5, 2025 | Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for B... | Safety and efficacy of dialysis acid concentrate cannot be assured | Class II | Diasol, Inc |
| Nov 5, 2025 | Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for B... | Safety and efficacy of dialysis acid concentrate cannot be assured | Class II | Diasol, Inc |
| Nov 5, 2025 | Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for B... | Safety and efficacy of dialysis acid concentrate cannot be assured | Class II | Diasol, Inc |
| Nov 5, 2025 | Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for B... | Safety and efficacy of dialysis acid concentrate cannot be assured | Class II | Diasol, Inc |
| Nov 5, 2025 | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. | Product testing did not meet expected stability criteria. | Class II | Cepheid |
| Nov 4, 2025 | Cardiosave Hybrid. Intra-Aortic Balloon Pump system. | The IFU addendum revises the Preventative Maintenance schedule to align with the update introduce... | Class II | Datascope Corp. |
| Nov 4, 2025 | Cardiosave Rescue. Intra-Aortic Balloon Pump system. | The IFU addendum revises the Preventative Maintenance schedule to align with the update introduce... | Class II | Datascope Corp. |
| Nov 3, 2025 | SQ40S Blood Transfusion Filter | Due to products being released for distribution prior to completion of the required quality contr... | Class II | GVS TM, Inc |
| Nov 3, 2025 | Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System ... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Continuous Glucose Monitor (CGM) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Estrogen & Progesterone Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Gut Microbiome Test Medium | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Vaginal PH Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Environmental Pollutants Profile Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Sorbitol Intolerance Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | IBS Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Neurotransmitters XL | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion Sys... | Labeling contains claims that are not consistently present. | Class III | Orthofix U.S. LLC |
| Nov 3, 2025 | Melatonin Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Women s Hormone Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Fecal Occult Blood Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Epstein-Barr Virus (EBV VCA & EBNA IgG) Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Neurotransmitters Basic | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | H pylori (Peptic ulcer) Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Men s Hormone Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Food Sensitivity Test Medium | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Ovulation Test (5 tests) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Allergy & Food Intolerance Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Pregnancy Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Liver Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Diabetes Test (ketones & glucose) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Iron Deficiency Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Herpes (HSV-1 & HSV-2) Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Thyroid TSH Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Iron Deficiency Test (ferritin) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Cholesterol Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Gonorrhea test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Chlamydia Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Gut Microbiome Test Large | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Hair Mineral Analysis | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Organic acids Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Drug Test Small (4 substances) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.