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 |
|---|---|---|---|---|
| Aug 21, 2019 | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... | Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... | Class II | Boston Scientific Corporation |
| Aug 6, 2019 | Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1V... | Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Ca... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Aug 6, 2019 | Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker. | Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Ca... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jul 8, 2019 | GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled ... | Potential for certain GRIPPER Needles to contain an occluded or blocked needle. | Class II | Smiths Medical ASD Inc. |
| Jul 8, 2019 | GRIPPER Needles sold individually. Labeled as the following item description... | Potential for certain GRIPPER Needles to contain an occluded or blocked needle. | Class II | Smiths Medical ASD Inc. |
| Jun 26, 2019 | IMRIS MR/X-ray head fixation device, Model HFD200 | Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond ... | Class II | Deerfield Imaging, Inc. |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replace... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of ... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of ... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 16, 2019 | Cepheid Xpert C. difficile/Epi Control Panel | Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. | Class III | Microbiologics Inc |
| May 15, 2019 | InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) ... | There is a potential for an unexpected increase in stimulation during InterStim programming with ... | Class II | Medtronic Neuromodulation |
| May 3, 2019 | AUTION HYBRID AU-4050 | This correction is being initiated due to a software issue which results in the possibility of in... | Class II | Arkray Factory USA, Inc. |
| Apr 10, 2019 | ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgica... | Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instrume... | Class II | Uromedica Inc. |
| Apr 9, 2019 | Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 7084535704... | Product with incorrect shelf life. | Class II | Microbiologics Inc |
| Apr 9, 2019 | Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226... | Product with incorrect shelf life. | Class II | Microbiologics Inc |
| Apr 5, 2019 | TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 P... | In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version ... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| Mar 4, 2019 | Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Produ... | The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury. | Class III | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Feb 11, 2019 | Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx... | Incorrect needle length and gage. | Class II | Smiths Medical ASD Inc. |
| Feb 11, 2019 | Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes in... | Packaged with an incorrect size inner cannula. | Class II | Smiths Medical ASD Inc. |
| Jan 31, 2019 | Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use | Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 mo... | Class II | Microbiologics Inc |
| Jan 17, 2019 | Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber ... | 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 17, 2019 | Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD):... | 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 17, 2019 | Medtronic implantable pulse generator: Versa, Dual chamber rate responsive p... | 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 17, 2019 | MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices | The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indica... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD):... | 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 17, 2019 | MEDTRONIC CARELINK 2090 programmer | There is an error in how the programmer calculates and displays the remaining longevity value dur... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1... | 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 17, 2019 | Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamb... | 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 17, 2019 | Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer | There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 po... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| 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 |
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.