Browse Device Recalls
78 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 78 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 78 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 10, 2018 | BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Nu... | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS 5F DL BIOFLO PASV, Catalog Number 60M132324 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | 5F DL BIOFLO PASV, Catalog Number 60M141006 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jan 18, 2018 | Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in F... | NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in a... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Oct 17, 2017 | Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL... | Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jan 13, 2017 | NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005 | The product has the potential to be non-sterile as it was not packaged in accordance to specifica... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 4... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalo... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalo... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 4... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-8... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM M... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-8... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalo... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No.... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 4... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog ... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 Th... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Nov 28, 2016 | XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 Th... | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 7, 2016 | Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the f... | The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Aug 29, 2016 | Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier ... | Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Aug 29, 2016 | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H... | Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Aug 29, 2016 | BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit... | Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jun 8, 2016 | Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-... | There is a potential for stylet stiffening that is not accurately represented on the labeling. Th... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jun 8, 2016 | Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-... | There is a potential for stylet stiffening that is not accurately represented on the labeling. Th... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Mar 21, 2016 | AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870,... | Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pr... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Mar 21, 2016 | Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Us... | Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pr... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
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.