Browse Device Recalls
1,734 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,734 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 1,734 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 1, 2023 | Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K),... | Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... | Class II | Covidien, LP |
| Mar 1, 2023 | Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT ... | Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... | Class II | Covidien, LP |
| Mar 1, 2023 | Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURG... | Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... | Class II | Covidien, LP |
| Mar 1, 2023 | Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sl... | Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... | Class II | Covidien, LP |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXI... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 16, 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S420... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3C... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STR... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, R... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106;... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b)... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Jan 20, 2023 | SenSight Connector Plug, Model Number B31061. | Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B... | Class II | Medtronic Neuromodulation |
| Dec 15, 2022 | AxiEM" Non-Invasive Patient Tracker | Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints an... | Class II | Medtronic Navigation, Inc. |
| Dec 12, 2022 | DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic No... | Class II | DeRoyal Industries Inc |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 8, 2022 | RadiaLux Lighted Retractor (Pink), REF: 50-101-1 | Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of conta... | Class II | Medtronic Navigation, Inc. |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104JP | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1205 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1102 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF MCS1705PU | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1103 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1101 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104CA-CLIN | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1100 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 21, 2022 | Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the ... | An app, part of a continuous glucose monitoring system, for use with smartphone devices may autom... | Class II | Medtronic MiniMed |
| Oct 14, 2022 | Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10M... | Due to a defect in the outer pouch sterile seal | Class II | Medtronic Navigation, Inc. |
| Sep 28, 2022 | Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLO... | Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential ... | Class II | Covidien, LP |
| Sep 28, 2022 | Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA00... | Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential ... | Class II | Covidien, LP |
| Sep 20, 2022 | Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 67... | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... | Class II | Medtronic MiniMed |
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.