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Browse Device Recalls

39 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39 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 39 FDA device recalls.

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DateProductReasonClassFirm
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.)
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 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 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
Mar 14, 2016 Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, R... 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, IR-145 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 Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels:... 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-60 Kit under the following labels: 1) 3F, UPN H9654... 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, Catheter 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 Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, ... 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-45 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 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 Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H96... PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... Class II Navilyst Medical, Inc., an AngioDyamics Company
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Nov 25, 2013 Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plasti... Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of ste... Class II 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.