Browse Device Recalls

36 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 36 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 36 FDA device recalls.

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Date	Product	Reason	Class	Firm
Apr 23, 2017	Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Su...	Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp...	Class II	Greatbatch Medical
Feb 15, 2017	Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small...	One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.	Class II	Greatbatch Medical
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.)
Nov 11, 2016	ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006	Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching durin...	Class II	Greatbatch Medical
Oct 19, 2016	Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usab...	On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints ...	Class II	Greatbatch Medical
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 8, 2016	Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer...	Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR ...	Class II	Greatbatch Medical
Aug 2, 2016	Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: T...	On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C ha...	Class I	Greatbatch Medical
Apr 26, 2016	Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distribute...	Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i...	Class II	Greatbatch Medical
Apr 26, 2016	Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: ...	Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i...	Class II	Greatbatch Medical
Apr 26, 2016	Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, N...	Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i...	Class II	Greatbatch Medical
Apr 28, 2014	Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems O...	Greatbatch identified that the documentation does not support the five-year shelf life of the Bar...	Class II	Greatbatch Medical
Jan 31, 2014	Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T1028...	Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Imp...	Class I	Greatbatch Medical
May 31, 2013	Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Acce...	Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE S...	Class II	Greatbatch Medical
Jan 16, 2013	45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY ...	Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Sm...	Class II	Greatbatch Medical
Nov 12, 2012	Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog...	Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guid...	Class II	Greatbatch Medical
Sep 24, 2012	Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog...	We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Dir...	Class II	Greatbatch Medical
Sep 6, 2012	Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distri...	During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardia...	Class II	Greatbatch Medical

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.