Browse Device Recalls
35,653 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,653 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 35,653 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 6, 2025 | BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 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 6, 2025 | BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD Alar... | Due to a number of modules flashed with a date and time associated with the daylight savings time... | Class II | CareFusion 303, Inc. |
| Nov 6, 2025 | Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, | Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration pr... | Class II | Bard Peripheral Vascular Inc |
| 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 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 | 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 | 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 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: 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: 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 | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. | Product testing did not meet expected stability criteria. | Class II | Cepheid |
| 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: 100425-10-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 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 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 3, 2025 | Mycotoxin Panel Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Food Sensitivity Test Small | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Food Sensitivity Test Large | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Allergy test Small | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Peptic Ulcer Test (H, pylori) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | 8 in 1 STI Test Kit | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Heavy Metals Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Fructose Intolerance Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | SIBO Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image proces... | GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.... | Class II | GE Healthcare GmbH |
| Nov 3, 2025 | Trichomonas Vaginalis test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Akkermansia Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Food Intolerance Test Medium | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Gut Microbiome Test Small | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Sperm Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Mycoplasma test, IgG and IgM | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Parasite Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Adrenal Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | HPV Antigen Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Neurotransmitters Plus | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Illegally Marketed | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Pollen Allergy Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Food Intolerance Test Small | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | GI Microbiome Profile XL | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a chec... | Class II | Fresenius Kabi USA, LLC |
| Nov 3, 2025 | Alcohol (ALC) Test Saliva | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Allergy test Small | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Allergy Test IgE | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Organic Acids Profile Test Large | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | PSA Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Candida Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Gut Microbiome Test XL | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Pet Allergy Test | 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.