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 |
|---|---|---|---|---|
| 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 28, 2016 | ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catal... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class II | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, Inc. |
| Sep 28, 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ... | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha... | Class III | Angiodynamics, 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.) |
| Jun 1, 2016 | AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203 | Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being... | Class I | Stryker Sustainability Solutions |
| 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.) |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 6523002... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No.... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 6... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
| Feb 5, 2015 | Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lum... | Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Tr... | Class II | Medical Components, Inc dba MedComp |
| Dec 19, 2014 | Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Prod... | Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle ... | Class II | Angiodynamics |
| Aug 6, 2014 | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Patter... | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... | Class II | Angiodynamics, Inc. |
| Aug 6, 2014 | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Patter... | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... | Class II | Angiodynamics, Inc. |
| Aug 6, 2014 | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Patter... | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... | Class II | Angiodynamics, Inc. |
| Jun 11, 2013 | AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cab... | The RITA Main Cable product contains the incorrect Instructions for Use. | Class II | Angiodynamics, INC |
| Apr 30, 2013 | AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following ... | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kit... | Class II | Angiodynamics, Inc. |
| Apr 30, 2013 | AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioD... | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kit... | Class II | Angiodynamics, Inc. |
| Jun 15, 2012 | AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size:... | AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter ... | Class II | Angiodynamics Worldwide Headquarters |
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.