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.

Clear

Date	Product	Reason	Class	Firm
Aug 12, 2013	Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for th...	Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration ...	Class II	Abbott Laboratories, Inc
Jul 31, 2013	VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint config...	The product has the potential to be laser marked as a Medium when it actually is a Small.	Class II	Spine Smith Holdings, LLC
Jul 25, 2013	Stryker Visum 300 Ceiling-mounted Exam Light.	Potential incomplete final weld on the drop tube flange.	Class II	Stryker Communications
May 24, 2013	VIA Medical Collection Bag; The collection bag is an accessory waste bag use...	International Biomedical has received reports of interference between the collection bag and the ...	Class II	International Biomedical, Ltd.
Apr 25, 2013	Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 ...	Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.	Class II	Instratek, Incorporated
Apr 1, 2013	3DKnee e+ Tibial Insert. The insert is used along with the other components t...	U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels...	Class II	Encore Medical, Lp
Mar 4, 2013	Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product...	An internal review of CareFusion's labeling for preoperative skin prep product codes was recently...	Class III	CareFusion 213, LLC
Feb 20, 2013	3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterio...	Manufacturing residue may be present on the cervical screws. Use of this product may result in p...	Class II	Genesys Orthopedic Systems, LLC
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
Dec 20, 2012	HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoP...	The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has t...	Class II	Healthtronics, Inc.
Dec 18, 2012	ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Quali...	Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative ...	Class II	Abbott Laboratories, Inc
Dec 5, 2012	Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I...	B. Braun Medical Inc. is informing our customers of a field correction previously performed to ad...	Class II	B Braun Medical, Inc.
Nov 30, 2012	Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 371...	There is issues of warmth or heating at the implant site during charging for the Eon Mini implant...	Class II	St. Jude Medical
Nov 16, 2012	Clinical Chemistry Phenobarbital, list number 1E08	Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773...	Class II	Abbott Laboratories, Inc
Nov 14, 2012	Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I...	This notice is being provided in follow up to the field correction initiated by B. Braun Medical ...	Class I	B Braun Medical, Inc.
Oct 31, 2012	Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I...	This notice is being provided in follow up to the field correction initiated by B. Braun Medical ...	Class II	B Braun Medical, Inc.
Oct 24, 2012	Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I...	B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. Th...	Class II	B Braun Medical, Inc.
Sep 28, 2012	6.5mm Cancellous Bone Screw Intended to be used for the fixation of the ac...	A product complaint was received where a size 20 screw was labeled as size 30. After receipt, mea...	Class II	Encore Medical, Lp
Sep 25, 2012	(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker F...	Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Ar...	Class II	Stryker Communications, Inc.
Sep 18, 2012	Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blad...	Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which c...	Class II	Instratek, Incorporated
Sep 17, 2012	BariAir Therapy System The BariAir Therapy System is a risk management tre...	KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The Bari...	Class II	KCI USA, Inc.
Sep 4, 2012	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable,...	Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimu...	Class II	Advanced Neuromodulation Systems Inc.
Aug 24, 2012	Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft,...	Implants were incorrectly laser marked as 23mm instead of 28mm.	Class II	Spine Smith Partners LP
Aug 9, 2012	3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vi...	The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The s...	Class II	Encore Medical, Lp
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
Jul 26, 2012	Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated ...	St. Jude Medical has informed your doctor that a number of cases have been reported in which disc...	Class II	St. Jude Medical
Jul 26, 2012	Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: E...	St. Jude Medical has informed your doctor that a number of cases have been reported in which disc...	Class II	St. Jude Medical
Jul 26, 2012	Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the mana...	As part of St. Jude Medical's routine tracking and product monitoring, they have received a total...	Class II	St. Jude Medical
Jul 16, 2012	djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for t...	One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint ...	Class II	Encore Medical, Lp
Jun 27, 2012	RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and preventio...	The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy Syste...	Class II	KCI USA, Inc.
Jun 11, 2012	Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold un...	This letter is to notify you that several of our sterile screw products are being voluntarily rec...	Class II	Tedan Surgical Innovations Llc
May 29, 2012	This voluntary medical device correction is related to Alcon products that pr...	This medical device correction is related to Alcon products that present a 23G non-valved trocar ...	Class II	Alcon Research, LTD.
May 29, 2012	IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Tran...	There was an error on the outer labeling of this device. The inner label was correct.	Class II	IDEV Technologies, Inc.
May 4, 2012	Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek ba...	Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may comprom...	Class II	Argon Medical Devices, Inc
Mar 28, 2012	Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator...	Unintended Fluid ingress into the device header has been shown.	Class II	Advanced Neuromodulation Systems Inc.
Dec 19, 2011	Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be con...	As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at th...	Class II	Advanced Neuromodulation Systems Inc.
Dec 19, 2011	The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rech...	As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at th...	Class II	Advanced Neuromodulation Systems Inc.
Dec 19, 2011	Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indica...	The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or...	Class II	Advanced Neuromodulation Systems 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.