Browse Device Recalls
3,029 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,029 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 3,029 FDA device recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 17, 2016 | Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Dimension Vista Assays: Uric Acid (URCA) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Dimension Vista Assays: Direct HDL Cholesterol (AHDL) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Medtronic Navigation O-arm 02 surgical x-ray imaging system | Review of on-system electronic product labeling and Instr uctions for Use in response to an inter... | Class II | Medtronic Navigation, Inc.-Littleton |
| Mar 17, 2016 | ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERI... | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Dimension Vista Assays: Triglycerides (TRIG) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Persona The Personalized Knee System Articular Surface Posterior Stabilized (... | The firm received a customer complaint establishing that the product (Persona PS Articular Surfac... | Class II | Zimmer Manufacturing B.V. |
| Mar 17, 2016 | enGen (TM) Laboratory Automation System configured with Thermo Scientific Rec... | The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may l... | Class II | Ortho-Clinical Diagnostics |
| Mar 17, 2016 | Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cle... | Foreign material in container | Class III | Cygnus Medical |
| Mar 17, 2016 | Dimension Assays: Direct HDL Cholesterol (AHDL) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Persona The Personalized Knee System Articular Surface Posterior Stabilized (... | The firm received a customer complaint establishing that the product (Persona PS Articular Surfac... | Class II | Zimmer Manufacturing B.V. |
| Mar 17, 2016 | Dimension Assays: ENZYMATIC CREATININE | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentra... | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Dimension Assays: Triglycerides (TGL) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 16, 2016 | da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & a... | Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2016 | da Vinci S Surgical System (IS4000) user manual English and OUS. Product U... | Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2016 | iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0... | A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database th... | Class II | Optovue, Inc. |
| Mar 16, 2016 | PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNAC... | Terumo Medical is initiating this recall due to complaints of valve leakage that have been relate... | Class II | Terumo Medical Corporation |
| Mar 15, 2016 | Junction Boxes, Product Usage: The Invacare Bariatric home care bed is i... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
| Mar 15, 2016 | Philips Healthcare System X-ray Tomography Computed : | It was discovered the patient support tabletop may fail to move in the horizontal direction when... | Class II | Philips Electronics North America Corporation |
| Mar 15, 2016 | cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian ... | An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instruct... | Class II | Roche Molecular Systems, Inc. |
| Mar 15, 2016 | EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus v... | New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised man... | Class II | Olympus Corporation of the Americas |
| Mar 15, 2016 | MEVION S250 for Proton Radiation Therapy | Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture m... | Class II | Mevion Medical Systems, Inc. |
| Mar 15, 2016 | Philips Healthcare System X-ray Tomography Computed : | It was discovered the patient support tabletop may fail to move in the horizontal direction when... | Class II | Philips Electronics North America Corporation |
| Mar 15, 2016 | STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon ... | Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should... | Class II | Ventlab LLC |
| Mar 15, 2016 | PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on Cardio... | This lot of test strips is showing an under-recovery when tested against a reference method. | Class II | Polymer Technology Systems, Inc. |
| Mar 15, 2016 | GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation... | The vacuum suction tubing could be kinked within the machine resulting in suction less than the 2... | Class II | GE Medical Systems, LLC |
| Mar 15, 2016 | Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usa... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
| Mar 15, 2016 | Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
| Mar 15, 2016 | Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to c... | Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal... | Class II | Merit Medical Systems, Inc. |
| Mar 15, 2016 | Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Pro... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
| Mar 14, 2016 | Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structu... | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Class II | Ossur H / F |
| Mar 14, 2016 | BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Ki... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M0014... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structu... | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Class II | Ossur H / F |
| Mar 14, 2016 | Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structur... | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Class II | Ossur H / F |
| Mar 14, 2016 | Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN ... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blo... | Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled becaus... | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 14, 2016 | BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H96595... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H96595... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M0014... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55c... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & ... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
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.