Browse Device Recalls
1,624 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,624 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 1,624 FDA device recalls in MN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 8, 2021 | Medical Device Identification Cards associated with Astra XT DR Implantable p... | The back of some Medical Device Identification Cards provided to patients were printed with an er... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 8, 2021 | Medical Device Identification Cards associated with Sprint Quattro Lead, Prod... | The back of some Medical Device Identification Cards provided to patients were printed with an er... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 8, 2021 | Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbe... | Manufacturing instructions did not include the directions to not retest the pneumatic kit compone... | Class II | Boston Scientific Corporation |
| Nov 4, 2021 | Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Ki... | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi... | Class II | Medtronic Neuromodulation |
| Nov 4, 2021 | Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Ki... | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi... | Class II | Medtronic Neuromodulation |
| Nov 4, 2021 | Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Ki... | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi... | Class II | Medtronic Neuromodulation |
| Oct 19, 2021 | Model B35200 - Percept PC BrainSense Implantable Neurostimulator | During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become... | Class II | Medtronic Neuromodulation |
| Oct 12, 2021 | Medtronic CareLink SmartSync Device Manager application software (D00U005) us... | The processing of collected episode data may fail due to a software error. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 12, 2021 | Medtronic Custom Perfusion kits, with the following product descriptions and ... | Product is labeled as non-pyrogenic but endotoxin testing was not performed. | Class II | Medtronic Perfusion Systems |
| Oct 6, 2021 | 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catal... | Potential for breakage of the ECG electrode carbon stud from the eyelet. | Class II | 3M Company - Health Care Business |
| Sep 27, 2021 | Cardioblate CryoFlex Surgical Ablation Console | There is potential for intermittent electrical connectivity between the console and probe. | Class II | Medtronic Perfusion Systems |
| Sep 23, 2021 | Clinician Programmer Application (CPA) model A610 Clinician Software Application | A software anomaly may occur with the clinician programmer application. | Class II | Medtronic Neuromodulation |
| Sep 13, 2021 | Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion... | There was a label mix-up between two model numbers resulting in the incorrect guidewire being con... | Class II | Medtronic Perfusion Systems |
| Sep 9, 2021 | C315-HIS Delivery Catheter | Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inabi... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Aug 25, 2021 | Operating room table - Product Usage: intended for use during diagnostic exam... | ORT200/300 rotational lock may fail to function such that it cannot change states between locked ... | Class II | Deerfield Imaging, Inc. |
| Aug 25, 2021 | Operating room table - Product Usage: intended for use during diagnostic exam... | ORT200/300 rotational lock may fail to function such that it cannot change states between locked ... | Class II | Deerfield Imaging, Inc. |
| Aug 25, 2021 | Operating room table - Product Usage: intended for use during diagnostic exam... | ORT200/300 rotational lock may fail to function such that it cannot change states between locked ... | Class II | Deerfield Imaging, Inc. |
| Aug 24, 2021 | DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only | Potential for a wire protrusion through the left heart vent catheter tip | Class II | Medtronic Perfusion Systems |
| Aug 24, 2021 | DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only | Potential for a wire protrusion through the left heart vent catheter tip | Class II | Medtronic Perfusion Systems |
| Aug 20, 2021 | SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an ext... | The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequ... | Class II | Microbiologics Inc |
| Aug 20, 2021 | SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an e... | The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically rele... | Class II | Microbiologics Inc |
| Aug 9, 2021 | Bivona Uncuffed Wire Endotracheal Tubes, | Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of... | Class II | Smiths Medical ASD Inc. |
| Aug 9, 2021 | Bivona Aire-Cuf Endotracheal Tube | Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of... | Class II | Smiths Medical ASD Inc. |
| Aug 6, 2021 | NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 | There is potential for harmful levels of aluminum leaching when using lower flow rates with certa... | Class I | Smiths Medical ASD Inc. |
| Aug 6, 2021 | NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR... | There is potential for harmful levels of aluminum leaching when using lower flow rates with certa... | Class I | Smiths Medical ASD Inc. |
| Aug 4, 2021 | smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X... | The incorrect device is contained in the package. | Class II | Smiths Medical ASD Inc. |
| Jul 27, 2021 | Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy... | The sterile barrier seal may be compromised. | Class II | Clarus Medical, Llc |
| Jul 23, 2021 | TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE) | Potential for leaks and loosening at the patient catheter connection | Class II | Boston Scientific Corporation |
| Jul 23, 2021 | MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 c... | There is potential for nonsterility of product due to a possible defect in the pouch seal. | Class II | Mivi Neuroscience Inc |
| Jul 23, 2021 | MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigationa... | There is potential for nonsterility of product due to a possible defect in the pouch seal. | Class II | Mivi Neuroscience Inc |
| Jul 23, 2021 | TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) | Potential for leaks and loosening at the patient catheter connection | Class II | Boston Scientific Corporation |
| Jul 21, 2021 | STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM,... | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged ... | Class II | Cardiovascular Systems Inc |
| Jul 21, 2021 | DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 ... | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged ... | Class II | Cardiovascular Systems Inc |
| Jul 21, 2021 | MPR Slotted Mallet, labeling etched onto devices as follows: Medical Prod... | Potential for mallet head to become separated from mallet handle. There is also significant defo... | Class II | Implant Resource Inc |
| Jul 15, 2021 | Pneupac paraPac plus 300 ventilator kit, REF P300NGB | Two devices were labeled with the same serial number | Class III | Smiths Medical ASD Inc. |
| Jul 9, 2021 | Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) ... | Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing ... | Class II | Medtronic Neuromodulation |
| Jun 21, 2021 | muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including ... | During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital s... | Class II | Murata Vios, Inc. |
| Jun 3, 2021 | Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f)... | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228 | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/1... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) ... | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f)... | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273 | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722 | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021) | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | VALITUDE CRT-P pacemaker, Models: a) U125 b) U128 | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 2, 2021 | Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3... | Excess nylon flash on the clip. | Class II | Medtronic Neuromodulation |
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.