Browse Device Recalls
1,646 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,646 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 1,646 FDA device recalls in MN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 17, 2019 | Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): ... | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 14, 2019 | 3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper C... | 3M has recently received reports involving the 3MTM Surgical Clipper by Remington¿, Model 9602, o... | Class II | 3M Company - Health Care Business |
| Dec 19, 2018 | Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of b... | A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires. | Class II | Boston Scientific Corporation |
| Nov 27, 2018 | RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation ... | Medtronic discovered that certain Y-connectors included in the suction lines have exhibited teari... | Class II | Medtronic Perfusion Systems |
| Nov 27, 2018 | SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Antic... | Medtronic discovered that certain Y-connectors included in the suction lines have exhibited teari... | Class II | Medtronic Perfusion Systems |
| Nov 26, 2018 | ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than in... | Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the saf... | Class II | Smiths Medical ASD Inc. |
| Nov 21, 2018 | Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits ... | Potential that product has not reached complete sterilization, | Class II | American Contract Systems, Inc. |
| Nov 19, 2018 | Medex High Pressure Stopcock used to control the direction of IV fluid flow. ... | Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that m... | Class II | Smiths Medical ASD Inc. |
| Nov 6, 2018 | IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000,... | Table may drift in the roll position while in use | Class II | Deerfield Imaging, Inc. |
| Nov 6, 2018 | IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product ... | Table may drift in the roll position while in use | Class II | Deerfield Imaging, Inc. |
| Nov 6, 2018 | IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000,... | Table may drift in the roll position while in use | Class II | Deerfield Imaging, Inc. |
| Nov 6, 2018 | IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, ... | Table may drift in the roll position while in use | Class II | Deerfield Imaging, Inc. |
| Nov 1, 2018 | Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The Qu... | The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorre... | Class III | R & D Systems, Inc. |
| Nov 1, 2018 | The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardiov... | Experienced accelerated battery depletion and a shortened replacement interval due to latent inte... | Class II | Boston Scientific Corporation |
| Oct 15, 2018 | Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software... | Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured p... | Class II | Smiths Medical ASD Inc. |
| Oct 2, 2018 | Medtronic CareLink 2090 Programmer | Vulnerabilities have been identified in the SDN download process that may allow an individual wit... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 2, 2018 | Medtronic CareLink Encore 29901 Programmer | Vulnerabilities have been identified in the SDN download process that may allow an individual wit... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Sep 17, 2018 | Reprocessed Agilis Steerable Introducer: indicated for introducing various c... | Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specific... | Class II | Sterilmed, Inc. |
| Sep 14, 2018 | Disposable Accessory Kit, 4-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 | 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... |
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.