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
Oct 28, 2015	Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat e...	The products have been found to intermittently exhibit a seal failure during use.	Class II	Quest Medical, Inc.
Oct 26, 2015	Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation ...	There is cracking in the tray when the device is snapped into place. The crack is through the ful...	Class II	ArthroCare Corporation
Oct 21, 2015	Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used...	The wire pass hole is not present on the tools.	Class II	Medtronic Sofamor Danek Usa, Inc - Dallas Distr...
Oct 7, 2015	Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106	Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartb...	Class II	Cyberonics, Inc
Sep 29, 2015	Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric...	Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ ...	Class I	Alcon Research, Ltd.
Sep 21, 2015	Custom Pak 9319-27. Single-use medical devices and accessories designed by m...	The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than th...	Class II	Alcon Research, Ltd.
Sep 16, 2015	Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For us...	The labeling is missing the size/diameter information.	Class II	Encore Medical, Lp
Sep 15, 2015	AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid ba...	Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the ...	Class II	Encore Medical, Lp
Sep 14, 2015	Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon ...	During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Imp...	Class II	Encore Medical, Lp
Sep 14, 2015	Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction ...	During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form t...	Class II	Encore Medical, Lp
Sep 9, 2015	ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vit...	Incorrect tubing.	Class II	Abbott Laboratories, Inc
Aug 11, 2015	LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue...	Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports...	Class II	Alcon Research, Ltd.
Aug 11, 2015	Alcon 23G and 25G Valved Entry System provides access into the posterior segm...	The product has potential to leak beyond their design specification.	Class II	Alcon Research, Ltd.
Aug 11, 2015	Custom Paks containing 23G and 25G valved trocar cannula provide access into ...	The product has potential to leak beyond their design specification.	Class II	Alcon Research, Ltd.
Aug 11, 2015	23G and 25G Constellation Totalplus Paks provides access into the posterior s...	The product has potential to leak beyond their design specification.	Class II	Alcon Research, Ltd.
Aug 7, 2015	IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL...	It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance...	Class II	International Biophysics Corp.
Aug 7, 2015	IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wan...	It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance...	Class II	International Biophysics Corp.
Aug 7, 2015	IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH...	It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance...	Class II	International Biophysics Corp.
Aug 6, 2015	7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONL...	The affected parts subject to the recall are out of specification, resulting in in the loss of th...	Class II	Trilliant Surgical Ltd.
Jul 31, 2015	2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot ...	Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specifica...	Class II	Trilliant Surgical Ltd.
Jul 20, 2015	3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw Syste...	The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the g...	Class II	Trilliant Surgical Ltd.
Jul 20, 2015	2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4....	The cutting efficiency of the Countersinks was out of specification.	Class II	Trilliant Surgical Ltd.
Jul 20, 2015	Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Hea...	Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported t...	Class II	Trilliant Surgical Ltd.
Jul 20, 2015	Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, ...	The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to...	Class II	Trilliant Surgical Ltd.
Jun 24, 2015	FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01...	The markings on the distal face of the instruments are mis-oriented by 180¿. This includes Anteri...	Class II	Encore Medical, Lp
Jun 18, 2015	Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Ma...	Potential defect in the forming of the primary package of the blister that may compromise the ste...	Class II	Argon Medical Devices, Inc
Jun 18, 2015	T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lo...	Potential defect in the forming of the primary package of the blister that may compromise the ste...	Class II	Argon Medical Devices, Inc
Jun 12, 2015	OxySure Model 615 disposable replacement cartridges, for portable oxygen gene...	Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimu...	Class II	Oxysure Systems, Inc.
Jun 9, 2015	Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Gui...	Inadequate interference between the screw and the plate when screw implanted into the plate at an...	Class II	Alliance Partners LLC
Jun 2, 2015	Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalo...	Insufficient seal on the outside packaging, potentially affecting the sterility of the product.	Class II	Alcon Research, Ltd.
Jun 2, 2015	EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable ...	Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (H...	Class II	ArthroCare Corporation
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 15, 2015	PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLAS...	Potential component failure resulting in inoperability	Class II	ArthroCare Medical Corporation
May 15, 2015	EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA ...	Potential component failure causing device inoperability	Class II	ArthroCare Medical Corporation
May 12, 2015	T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm ...	Potential breach in sterility	Class II	Vidacare Corporation
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
Apr 28, 2015	The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use...	The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves d...	Class II	Alcon Research, Ltd.
Apr 21, 2015	PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT...	At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was...	Class II	Hitachi America, Ltd., Power Systems Division
Apr 15, 2015	ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcryS...	There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) ...	Class I	Alcon Research, Ltd.
Mar 30, 2015	OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO...	Potential for clear extension tube to separate from the hub, which could result in blood loss and...	Class I	OriGen Biomedical, Inc.
Mar 30, 2015	REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NO...	Potential for clear extension tube to separate from the hub, which could result in blood loss and...	Class I	OriGen Biomedical, Inc.
Mar 16, 2015	Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 ...	Battery packs may heat up abnormally and ignite in rare instance.	Class II	Arcos, Inc
Mar 6, 2015	VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Gener...	The pulse generators have a lower battery longevity than specified in their design requirement as...	Class II	Cyberonics, Inc
Feb 26, 2015	LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthal...	Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels	Class II	Quest Medical, Inc.
Feb 23, 2015	Mobius3D Product Usage: Mobius3D software is used for quality assurance a...	Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam c...	Class II	Mobius Medical Systems, LP
Feb 20, 2015	Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E)...	The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L...	Class II	ArthroCare Medical Corporation
Feb 3, 2015	Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made ...	The toothbrush head can potentially disengage from the handle.	Class II	Norwex Usa Inc
Jan 15, 2015	ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the ...	There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to th...	Class II	Abbott Laboratories, Inc
Jan 13, 2015	ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 70...	The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.	Class II	Med-logics Inc
Dec 11, 2014	MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Bre...	The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect....	Class II	Mentor Texas, LP.

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.