Browse Device Recalls

31 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 31 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 31 FDA device recalls.

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Date	Product	Reason	Class	Firm
Apr 6, 2018	Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Pa...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part N...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbe...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Num...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on labe...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Pa...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on ...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part N...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Pa...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbe...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Le...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx On...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Par...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Apr 6, 2018	Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx ...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, Inc
Feb 23, 2018	ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002	Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) w...	Class II	Orthofix, Inc
Feb 23, 2018	ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003	Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) w...	Class II	Orthofix, Inc
Aug 2, 2017	Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, n...	The plastic core of the Decorticating Planer was found to be missing, which could result in scori...	Class II	Orthofix, Inc
Apr 27, 2016	Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set scr...	There is a possibility that the subject set screw driver could disengage from the torque limiting...	Class II	Orthofix, Inc
Jan 8, 2016	Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intend...	There is a possibility that the device may deliver a torque value less than the required setting ...	Class II	Orthofix, Inc
May 18, 2015	ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Sta...	The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabel...	Class II	Orthofix, Inc
May 11, 2015	ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill G...	There is a possibility that the thumb button remains in the depressed (unlocked) position allowin...	Class II	Orthofix, Inc
Nov 26, 2013	Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver...	Orthofix received 6 complaints which resulted in a reportable events due to extended surgical tim...	Class II	Orthofix, Inc.
Oct 29, 2013	Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Tit...	There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fractu...	Class II	Orthofix, Inc
Feb 1, 2013	Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial R...	There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connect...	Class II	Orthofix, Inc
Aug 6, 2012	Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distra...	There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during...	Class II	Orthofix, 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.