Browse Device Recalls

788 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 788 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 788 FDA device recalls in TX.

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Date	Product	Reason	Class	Firm
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
Mar 27, 2018	Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile	Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demo...	Class II	Trilliant Surgical Ltd.
Mar 27, 2018	Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile	Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demo...	Class II	Trilliant Surgical Ltd.
Mar 9, 2018	Proclaim DRG Implantable Pulse Generator, Model Number 3664	The firm received complaints of error messages that occurred during routine impedance checks on P...	Class II	St. Jude Medical, Inc.
Feb 27, 2018	SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation a...	Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended...	Class III	Helena Laboratories, Corp.
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
Feb 13, 2018	RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (...	All patient serum samples yield a weakly positive test result.	Class II	Stanbio Laboratory, LP
Feb 8, 2018	Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The...	The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outl...	Class II	Stanbio Laboratory, LP
Jan 30, 2018	AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 8...	Broken or missing screws and retaining clips. This may be due to screw tolerance and material st...	Class II	Encore Medical, Lp
Jan 29, 2018	Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 8...	It was discovered during a surgery that the design of the radius at the base of the pegs of the A...	Class II	Encore Medical, Lp
Jan 29, 2018	Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000...	The device could have a missing spanner nut and snap ring which could potentially result in the e...	Class II	Stryker Communications
Jan 29, 2018	Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 8...	It was discovered during a surgery that the design of the radius at the base of the pegs of the A...	Class II	Encore Medical, Lp
Jan 29, 2018	Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 8...	It was discovered during a surgery that the design of the radius at the base of the pegs of the A...	Class II	Encore Medical, Lp
Jan 29, 2018	Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 8...	It was discovered during a surgery that the design of the radius at the base of the pegs of the A...	Class II	Encore Medical, Lp
Jan 29, 2018	Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 8...	It was discovered during a surgery that the design of the radius at the base of the pegs of the A...	Class II	Encore Medical, Lp
Jan 26, 2018	Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a componen...	The mounts on the monitor may have an insufficient (missing or incomplete) weld.	Class II	Stryker Communications
Jan 24, 2018	VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2	Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 program...	Class II	LivaNova USA Inc
Jan 12, 2018	Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a c...	Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+...	Class II	Alcon Research, LTD.
Jan 12, 2018	Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a c...	Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+...	Class II	Alcon Research, LTD.
Dec 28, 2017	NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile	Potential for stylet to protrude from the distal end of the catheter	Class II	Epimed International
Dec 28, 2017	NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile	Potential for stylet to protrude from the distal end of the catheter	Class II	Epimed International
Dec 12, 2017	EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Q...	The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla...	Class II	Encore Medical, Lp
Dec 12, 2017	EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE,...	The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla...	Class II	Encore Medical, Lp
Dec 12, 2017	DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qt...	The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla...	Class II	Encore Medical, Lp
Dec 12, 2017	EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Q...	The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla...	Class II	Encore Medical, Lp
Dec 8, 2017	ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the A...	There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th...	Class II	Abbott Laboratories, Inc
Dec 8, 2017	ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARC...	There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th...	Class II	Abbott Laboratories, Inc
Dec 8, 2017	ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARC...	There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th...	Class II	Abbott Laboratories, Inc
Dec 7, 2017	Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on...	Some of the cards show occasional shorter clot times than the expected variation resulting in a p...	Class II	Helena Laboratories, Corp.
Dec 2, 2017	VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Us...	Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 ...	Class II	Cyberonics, Inc
Nov 22, 2017	Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap...	Component of the Lap-Band system was missing from the package	Class II	Apollo Endosurgery 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.