Browse Device Recalls
1,677 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,677 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 1,677 FDA device recalls in MN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 14, 2018 | Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek ... | The pouches of certain lots of product may have wrinkles along the pouch seal that could result i... | Class II | Ecolab Inc |
| Sep 14, 2018 | Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx S... | The pouches of certain lots of product may have wrinkles along the pouch seal that could result i... | Class II | Ecolab Inc |
| Sep 14, 2018 | Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / ... | The pouches of certain lots of product may have wrinkles along the pouch seal that could result i... | Class II | Ecolab Inc |
| Sep 11, 2018 | R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, RE... | The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D... | Class III | R & D Systems, Inc. |
| Sep 10, 2018 | VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) | Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva... | Class II | Boston Scientific Corporation |
| Sep 10, 2018 | Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Sci... | There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber sti... | Class II | Boston Scientific Corporation |
| Sep 10, 2018 | ESSENTIO Pacemaker | Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva... | Class II | Boston Scientific Corporation |
| Sep 10, 2018 | ACCOLADE Pacemaker | Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva... | Class II | Boston Scientific Corporation |
| Sep 10, 2018 | PROPONENT Pacemaker | Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva... | Class II | Boston Scientific Corporation |
| Sep 10, 2018 | VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) | Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva... | Class II | Boston Scientific Corporation |
| Aug 29, 2018 | INSORB SUBCUTICULAR SKIN STAPLER, REF 2030 | Possible compromise of the sterile barrier integrity | Class II | Incisive Surgical Inc |
| Aug 22, 2018 | Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Mode... | Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped punctur... | Class II | Smiths Medical ASD Inc. |
| Aug 8, 2018 | Extra corporeal circuit with bio-active surface. | Affected products failed a sterilization test. | Class II | Medtronic Perfusion Systems |
| Jul 13, 2018 | Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase... | The product was mislabeled with the incorrect label. | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Ti... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use... | Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous ... | Class II | 3M Company - Health Care Business |
| Jul 6, 2018 | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flare... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Fl... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jun 28, 2018 | Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes... | Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than... | Class II | Envoy Medical Corporation |
| Jun 22, 2018 | Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial B... | The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain th... | Class II | Smiths Medical ASD Inc. |
| Jun 22, 2018 | Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial B... | The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain th... | Class II | Smiths Medical ASD Inc. |
| Jun 21, 2018 | Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The imp... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models a... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The imp... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P mod... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P mod... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models a... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 12, 2018 | Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep... | Incorrect use-by date on the device registration/patient file labels. | Class II | Inspire Medical Systems Inc. |
| Jun 6, 2018 | Single Chamber Temporary External Pacemaker, Model 53401 | A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 25, 2018 | Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 25, 2018 | Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 10, 2018 | medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 0... | Product has a lack of sterility assurance | Class II | Smiths Medical ASD Inc. |
| May 4, 2018 | Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9c... | The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a p... | Class II | Vascular Solutions, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 13, 2018 | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Nu... | The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing tr... | Class II | Cardiovascular Systems Inc |
| Apr 13, 2018 | Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism | Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, r... | Class II | Smiths Medical ASD Inc. |
| Apr 4, 2018 | IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative M... | The DC power to the IFOSS collision detector control panel at your facility is being adversely af... | Class II | Deerfield Imaging, Inc. |
| Apr 2, 2018 | Bivona¿ Tracheostomy Tube Tracheostomy Tubes | Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as s... | Class II | Smiths Medical ASD Inc. |
| Mar 26, 2018 | AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis... | Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. | Class II | Tornier, Inc |
| Feb 23, 2018 | IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for... | The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot c... | Class II | Deerfield Imaging, 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.