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 |
|---|---|---|---|---|
| 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 |
| Jun 1, 2021 | Medtronic Reveal LINQ LNQ11 / PA96000 | Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 28, 2021 | Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray compone... | Two lots have been swapped thus have the incorrect product in the package. The component may be o... | Class II | Tornier, Inc |
| May 17, 2021 | JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2... | Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 2... | Class I | Smiths Medical ASD Inc. |
| May 14, 2021 | PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Pr... | One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may... | Class II | Smiths Medical ASD Inc. |
| May 14, 2021 | Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO ... | Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through PO... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 5, 2021 | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model... | Due to a software error, the user may lose functionality of the system or the screen may turn bla... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| May 5, 2021 | WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 | Due to a software error, the user may lose functionality of the system or the screen may turn bla... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| May 5, 2021 | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Displ... | Due to a software error, the user may lose functionality of the system or the screen may turn bla... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| Apr 29, 2021 | Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, St... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, ... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System,... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Ster... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Ste... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion Sys... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion Syst... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion Sy... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion S... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, ... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, ... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion Sys... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, S... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, S... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, ... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfu... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion Sys... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, ... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Cust... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
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.