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 |
|---|---|---|---|---|
| Aug 23, 2017 | North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system.... | It was discovered a low-level radiation leak that was found on the NSI X-7000 system. | Class II | North Star Imaging Inc |
| Aug 22, 2017 | Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactu... | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accu... | Class II | Smiths Medical ASD Inc. |
| Aug 22, 2017 | Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufacture... | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accu... | Class II | Smiths Medical ASD Inc. |
| Aug 14, 2017 | UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/08... | Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy T... | Class II | Smiths Medical ASD Inc. |
| Aug 14, 2017 | IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw | incorrect thread on thumbscrews | Class II | Deerfield Imaging |
| Aug 9, 2017 | Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size ... | Medtronic implemented a final design change intended to address the motor stall due to corrosion ... | Class II | Medtronic Neuromodulation |
| Jul 28, 2017 | Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc.... | Needle Bond may not be able to withstand the tension force applied when the shaped needle is depl... | Class II | NXTHERA |
| Jul 14, 2017 | MyCareLink Patient Monitors. It is intended for used with a compatible Med... | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Jul 14, 2017 | MyCareLink Smart Patient Monitors. It is intended for use with a compatibl... | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Jun 29, 2017 | EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator... | The device can deliver an atypical amount of energy due to memory corruption inside the device. | Class II | Boston Scientific Corporation |
| Jun 29, 2017 | EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrill... | The device can deliver an atypical amount of energy due to memory corruption inside the device. | Class II | Boston Scientific Corporation |
| Jun 29, 2017 | SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is inten... | The device can deliver an atypical amount of energy due to memory corruption inside the device. | Class II | Boston Scientific Corporation |
| Jun 22, 2017 | DLP Extension Line Adapters 20 in length Used to extend cardioplegia line du... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure m... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia altern... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Pressure Disposable Pressure Display Sets Extends the pressure line in o... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 14, 2017 | mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Ma... | Potential failure in the balloon bond in the inner catheter stem, leading to the separation of th... | Class II | Medspira, Llc |
| Jun 6, 2017 | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenz... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics Inc |
| Jun 6, 2017 | Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics Inc |
| Jun 6, 2017 | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respirat... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics Inc |
| Jun 6, 2017 | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseri... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics Inc |
| Jun 6, 2017 | Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Ve... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics Inc |
| Jun 5, 2017 | CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented... | The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been... | Class II | Smiths Medical ASD Inc. |
| Jun 2, 2017 | St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Cur... | Inadequate seal due to lack of adhesive glue | Class I | Sterilmed Inc |
| May 22, 2017 | 3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger P... | It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber... | Class II | 3M Company - Health Care Business |
| May 15, 2017 | CADD¿ High Volume Administration Set with FlowStop, 21-7381-24. Product U... | One lot of CADD¿ High Volume Administration sets, part number 21-7381-24, lot number 26X035, inco... | Class II | Smiths Medical ASD Inc. |
| May 8, 2017 | Electrophysiology catheter cables are designed as electrode cables with a mu... | Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP A... | Class II | Sterilmed Inc |
| Apr 25, 2017 | Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS... | Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a pot... | Class I | Vascular Solutions, Inc. |
| Apr 23, 2017 | Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Su... | Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp... | Class II | Greatbatch Medical |
| Apr 14, 2017 | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Nu... | Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusi... | Class II | Cardiovascular Systems Inc |
| Apr 12, 2017 | Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Qu... | An unexpected transient mode switch behavior was detected by Medtronic during systems testing tha... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Apr 12, 2017 | Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxi... | The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the ... | Class II | Vascular Solutions, Inc. |
| Apr 5, 2017 | The JETSTREAM is a rotational atherectomy catheter system designed for use in... | Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lo... | Class II | Boston Scientific Corporation |
| Apr 4, 2017 | Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 &... | Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medica... | Class II | Smiths Medical ASD Inc. |
| Apr 4, 2017 | Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the d... | It was discovered the unit produced a laser emission without pressing the fire button when the sl... | Class II | Laserex Systems Inc. |
| Mar 17, 2017 | DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead ... | Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which c... | Class II | Medtronic Neuromodulation |
| Mar 17, 2017 | CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO. | Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yel... | Class II | Smiths Medical ASD Inc. |
| Mar 13, 2017 | Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Eso... | The reusable temperature probes are provided with instructions for sterilization that have not be... | Class II | Measurement Specialties Inc |
| Mar 3, 2017 | ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18.... | Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW... | Class II | Cardiovascular Systems Inc |
| Mar 2, 2017 | KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK... | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | Class III | Microbiologics Inc |
| Mar 2, 2017 | LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO... | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | Class III | Microbiologics Inc |
| Feb 15, 2017 | Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small... | One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed. | Class II | Greatbatch Medical |
| Feb 9, 2017 | SynchroMed II implantable drug infusion pump, Model 8637-40, | Medtronic received a complaint that there was an error code displayed on the programmer when the... | Class II | Medtronic Neuromodulation |
| Feb 9, 2017 | ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number... | CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . ... | Class II | Cardiovascular Systems Inc |
| Feb 9, 2017 | Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, ... | Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy ... | Class II | Smiths Medical ASD Inc. |
| Jan 13, 2017 | InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction ... | Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfus... | Class II | Vertebral Technologies, Inc. |
| Jan 12, 2017 | Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer. | There is a potential for radio frequency (RF) interference to alter wireless communication from a... | Class II | Boston Scientific Corporation |
| Jan 12, 2017 | GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. ... | Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf lif... | Class II | Vascular Solutions, Inc. |
| Dec 15, 2016 | Boston Scientific Imager II Angiographic Catheter, a pathway for delivering c... | A field report indicated some units within this lot were missing the bottom pouch seal. The comp... | 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.