Browse Device Recalls
81 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 81 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 81 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 16, 2025 | Catalyft PL & PL40 Expandable Interbody System labeled as follows with corres... | Expandable interbody system cage may loose height or collapse (loss of lordosis), which could res... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 26, 2023 | Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 26, 2023 | Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized... | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 26, 2023 | Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T... | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 26, 2023 | Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demin... | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 26, 2023 | Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d)... | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 26, 2023 | Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone M... | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 26, 2023 | Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 31, 2023 | Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, De... | The incorrect product labeling was applied to the product indicating the wrong size of product. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Stand... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| 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 |
| Nov 19, 2021 | Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set... | Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest w... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 2, 2021 | Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, N... | Engraving on implants may not match what is listed on the pouch labels. | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 2, 2021 | Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, N... | Engraving on implants may not match what is listed on the pouch labels. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Numbe... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Numbe... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldab... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, mold... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldab... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Mar 26, 2020 | VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 | Nonconforming product; length of the product measured shorter than the labeled length. | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 27, 2018 | INFUSE Bone Graft X SMALL KIT REF 7510100 | The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sp... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 9, 2018 | Medtronic CD HORIZON Spinal System is intended to help provide immobilization... | This lot has incorrectly been laser marked both on the screw head itself as well as the data carr... | Class II | Medtronic Sofamor Danek USA Inc |
| Mar 23, 2018 | Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Si... | Slot screw had an overall length of 15mm, but per the specification, the screw should have an ove... | Class II | Medtronic Sofamor Danek USA Inc |
| Mar 13, 2018 | Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, ... | The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical ... | Class II | Medtronic Sofamor Danek USA Inc |
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.