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 |
|---|---|---|---|---|
| Feb 22, 2021 | Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Produc... | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Feb 22, 2021 | AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer... | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Oct 2, 2019 | Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 ... | The devices are not labelled correctly. End users impacted by this issue may experience a proced... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 ... | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040... | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 ... | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022 | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 18, 2019 | BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-02... | Snap lock connectors provided within implantable port kits may not meet dimensional specification... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero G... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Appli... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Appl... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Apr 17, 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generat... | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to re... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Oct 16, 2018 | BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL ... | specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration d... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Oct 16, 2018 | Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE ... | Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration d... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jul 24, 2018 | BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PL... | BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual ste... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| May 10, 2018 | Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901 | 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 60M161567 | 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 PICC, Catalog Number 60M250097 | 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) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG... | 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 with Nitinol Guidewire PG, Catalo... | 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, Catalog Number 60M030393 | 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 w/70cm Nitinol Wir... | 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 60M120196 | 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 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.) |
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.