Browse Device Recalls
182 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 182 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 182 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 10, 2018 | Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Numbe... | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number... | 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 XCELA PICC, Catalog Number 60M122272 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472 | 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 60M183481 | 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 DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire 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 XPP KIT, Catalog Number 60M183104 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Numbe... | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45... | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidew... | 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 PICC, Catalog Number 60M071831 | 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 60M181578 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003 | 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 60M150373 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582 | 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 DUAL XCELA PICC, Catalog Number 60M701532 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire P... | 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 PICC, Catalog Number 60M180592 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | RS TANDEM 5F DL XPP, Catalog Number 60M019881 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| 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.) |
| Sep 22, 2017 | Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 c... | Product was placed into distribution prior to completion of all required post sterilization relea... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN)... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H78... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) ... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (U... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, Inc. |
| Jun 5, 2017 | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model ... | The firm is recalling product that has the potential to not function during use. The product af... | Class II | Angiodynamics, 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.) |
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.