Browse Device Recalls
35,226 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,226 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 35,226 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 22, 2026 | Da Vinci ASSY, PSS, SP1098, Part Number: 380601 | Operative components of surgical systems potentially distributed with E-brake retainer pin, so in... | Class II | Intuitive Surgical, Inc. |
| Apr 22, 2026 | Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalo... | Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of th... | Class II | Baxter Healthcare Corporation |
| Apr 22, 2026 | BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. | Contamination to in-vitro diagnostic test may result in false positives. | Class II | BioFire Diagnostics, LLC |
| Apr 21, 2026 | Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in con... | The Adapter for Head Positioning accessory may become loose during patient positioning and uninte... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2026 | Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 | A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in ... | Class II | PFM MEDICAL INC. |
| Apr 21, 2026 | MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analys... | Software in development inadvertently made available for customer use. Use of this software versi... | Class II | GE Medical Systems China Co., Ltd. |
| Apr 21, 2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Mode... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Mo... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 20, 2026 | navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navif... | Due to complaints received for the Image Management System regarding image/metadata discrepancy w... | Class II | Ventana Medical Systems, Inc. |
| Apr 20, 2026 | Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 ... | Due to a software coding issues for calculating the implant orientation diagram printout for the ... | Class II | Staar Surgical AG |
| Apr 20, 2026 | Allia IGS 7 Pulse angiographic X-ray system | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... | Class II | GE Medical Systems, LLC |
| Apr 20, 2026 | Allia IGS 5 Pulse angiographic X-ray system | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... | Class II | GE Medical Systems, LLC |
| Apr 20, 2026 | Allia Moveo angiographic X-ray system | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... | Class II | GE Medical Systems, LLC |
| Apr 20, 2026 | Allia IGS Pulse angiographic X-ray system | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... | Class II | GE Medical Systems, LLC |
| Apr 20, 2026 | Allia IGS 3 Pulse angiographic X-ray system | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... | Class II | GE Medical Systems, LLC |
| Apr 20, 2026 | Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography... | Electromagnetic contactors within high voltage generator may weld together, resulting in current ... | Class II | Shimadzu Medical Systems |
| Apr 16, 2026 | Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Numbe... | It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not... | Class II | The Binding Site Group, Ltd. |
| Apr 15, 2026 | Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH ... | A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument ... | Class II | Fresh Roast Systems Inc |
| Apr 15, 2026 | Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 1700... | The presence of holes in the pouch may compromise the package s ability to maintain the sterile b... | Class II | Covidien, LP |
| Apr 15, 2026 | COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI ... | Due to customer complaint regarding incorrect display box labeling. | Class II | Covidien LLC |
| Apr 14, 2026 | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... | A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... | Class II | Dexcom, Inc. |
| Apr 14, 2026 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... | Class II | Dexcom, Inc. |
| Apr 14, 2026 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... | Class II | Dexcom, Inc. |
| Apr 14, 2026 | Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Mode... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). ... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (R... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (R... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (RE... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Numbe... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model ... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF)... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (RE... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF)... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (R... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Numbe... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Mod... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Mode... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 13, 2026 | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: ... | Due to incorrect incubation process being performed on product. | Class II | HF Acquisition Co LLC |
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.