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 |
|---|---|---|---|---|
| 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 |
| Dec 13, 2016 | Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer p... | One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The ... | Class II | Boston Scientific Corporation |
| Dec 9, 2016 | Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria M... | During internal testing conducted as part of next generation product development, it was discover... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Dec 9, 2016 | Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Steri... | The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is co... | Class II | Smiths Medical ASD Inc. |
| Dec 7, 2016 | DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Or... | CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. | Class II | Cardiovascular Systems Inc |
| Nov 30, 2016 | Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only. | The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the... | Class III | Ecolab Inc |
| Nov 30, 2016 | Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly. | Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing le... | Class II | Boston Scientific Corporation |
| Nov 21, 2016 | Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvan... | Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720... | Class II | Smiths Medical ASD Inc. |
| Nov 16, 2016 | Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion... | Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusio... | Class II | Medtronic Inc |
| Nov 11, 2016 | ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 | Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching durin... | Class II | Greatbatch Medical |
| Nov 10, 2016 | ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross... | Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire... | Class II | Medtronic Inc |
| Oct 31, 2016 | CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102... | 20 Pumps sold to the Finnish market contain a message in which one word in the message is mistran... | Class II | Smiths Medical ASD, Inc. |
| Oct 31, 2016 | HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotl... | HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the requir... | Class III | Smiths Medical ASD, Inc. |
| Oct 26, 2016 | 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Univer... | 3M is recalling Universal Electrosurgical Pads because a report of an unintended material (proces... | Class II | 3M Company - Health Care Business |
| Oct 25, 2016 | NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reo... | Smiths Medical became aware that that one (1) NORMOFLO¿ H-1100 Irrigation Fluid Warmers was incor... | Class II | Smiths Medical ASD, Inc. |
| Oct 20, 2016 | Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number S... | The sterile packaging may contain small channels in the seal of the pouch, If the channels are p... | Class II | Micromedics, Inc. |
| Oct 19, 2016 | Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usab... | On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints ... | Class II | Greatbatch Medical |
| Oct 11, 2016 | Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Per... | Nuvectra is conducting a recall due to two clinical risks that are associated with certain percu... | Class II | Nuvectra |
| Oct 3, 2016 | Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a h... | Medtronic has identified an increased number of complaints from customers involving reports of Re... | Class II | Medtronic Neuromodulation |
| Oct 3, 2016 | Medtronic SynchroMed II Implantable Drug Infusion System. This system includ... | Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for th... | Class I | 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.