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 |
|---|---|---|---|---|
| Mar 14, 2022 | Hillrom Temperature Management Controller, MP, Model # 2083516; used in conju... | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... | Class II | Augustine Temperature Management, LLC |
| Mar 14, 2022 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... | Class II | Augustine Temperature Management, LLC |
| Mar 14, 2022 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... | Class II | Augustine Temperature Management, LLC |
| Mar 8, 2022 | ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support | Pouch seals may be open, compromising sterility. | Class II | Boston Scientific Corporation |
| Mar 8, 2022 | ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy | Pouch seals may be open, compromising sterility. | Class II | Boston Scientific Corporation |
| Mar 3, 2022 | Pneumonia (33 Targets) Control Panel, unassayed quality control material, con... | Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of... | Class II | Microbiologics Inc |
| Mar 2, 2022 | Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonar... | There is potential for the capsule bond to break during the procedure. | Class I | Medtronic Inc |
| Feb 28, 2022 | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the fo... | There is a software anomaly with the InterStim X Clinician software application with results in t... | Class II | Medtronic Neuromodulation |
| Feb 25, 2022 | Mycoplasma genitalium Control Panel (Inactivated Pellet) | Distributed product did not undergo proper release testing. | Class II | Microbiologics Inc |
| Feb 17, 2022 | Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a co... | Reports have been received that after normal or routine lateral forces are applied to the head fi... | Class II | Deerfield Imaging, Inc. |
| Feb 4, 2022 | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Cat... | The device has similarities in design to another device that the firm recently issued a field cor... | Class I | ev3 Inc. |
| Feb 4, 2022 | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Cat... | The device has similarities in design to another device that the firm recently issued a field cor... | Class I | ev3 Inc. |
| Jan 18, 2022 | LINQ II Insertable Cardiac Monitor | Devices may lose functionality due to susceptibility to moisture ingress. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 6, 2021 | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1... | Reports have been received of tip damage during use of the devices which resulted in some instanc... | Class I | ev3 Inc. |
| Dec 6, 2021 | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1... | Reports have been received of tip damage during use of the devices which resulted in some instanc... | Class I | ev3 Inc. |
| Nov 22, 2021 | WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval ... | Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under s... | Class I | Cardiovascular Systems Inc |
| Nov 22, 2021 | UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, ... | The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed thro... | Class II | Uromedica Inc. |
| Nov 19, 2021 | Instructions for Use for all model numbers of the Medtronic Abre Venous Self-... | There have been reports of stent migration. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 16, 2021 | Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM | As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was m... | Class II | Abbott |
| Nov 10, 2021 | iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery S... | The dosage information on the pouch is incorrect; the primary carton label is correct. | Class III | Tapemark Company |
| Nov 9, 2021 | Amplatzer Steerable Delivery Sheath | Instructions for use were updated. | Class II | Abbott |
| Nov 9, 2021 | Torosa Saline-Filled Testicular Prosthesis (Size Small) | Product is mislabeled for size. | Class II | Coloplast Manufacturing US, LLC |
| 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 |
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.