Browse Device Recalls

816 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 816 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 816 FDA device recalls in TX.

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DateProductReasonClassFirm
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.