Browse Device Recalls
740 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 740 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 740 FDA device recalls in TN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 19, 2025 | Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Mo... | Due to products not having FDA Premarket authorization to be distributed within the United States. | Class II | MicroPort Orthopedics Inc. |
| 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 |
| Aug 12, 2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in... | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... | Class I | Max Mobility LLC |
| Aug 12, 2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in ... | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... | Class I | Max Mobility LLC |
| Aug 12, 2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use i... | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... | Class I | Max Mobility LLC |
| Jul 19, 2025 | Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit M... | Device contains indications for use and device compatibility claims that have not be reviewed and... | Class II | Insightra Medical Inc |
| Mar 18, 2025 | META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 | Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be unde... | Class II | Smith & Nephew, Inc. |
| Jan 31, 2025 | DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tu... | Due to the inner diameter of the suction tubing connector being smaller than the suction canister... | Class II | DeRoyal Industries Inc |
| Jan 15, 2025 | DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C... | The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer con... | Class II | DeRoyal Industries Inc |
| Jan 2, 2025 | Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK ... | Due to devices being irradiated above the established specification which my result in package in... | Class II | US Endodontics, LLC |
| Dec 20, 2024 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use i... | Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power a... | Class I | Max Mobility LLC |
| Dec 20, 2024 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in... | Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power a... | Class I | Max Mobility LLC |
| Oct 29, 2024 | EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5... | Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary ha... | Class II | MicroPort Orthopedics Inc. |
| Oct 15, 2024 | Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I... | The Bipolar assembly contains an oversized Retainer Ring. | Class II | Smith & Nephew, Inc. |
| Oct 3, 2024 | DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker Safe... | Class II | DeRoyal Industries Inc |
| Oct 3, 2024 | DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker Safe... | Class II | DeRoyal Industries Inc |
| Oct 3, 2024 | DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker Safe... | Class II | DeRoyal Industries Inc |
| Oct 3, 2024 | DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker Safe... | Class II | DeRoyal Industries Inc |
| Oct 2, 2024 | smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 L... | Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant inst... | Class II | Smith & Nephew Inc |
| Oct 2, 2024 | smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZ... | Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implan... | Class II | Smith & Nephew Inc |
| Oct 2, 2024 | smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT,... | Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implan... | Class II | Smith & Nephew Inc |
| Oct 2, 2024 | smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 L... | Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant inst... | Class II | Smith & Nephew Inc |
| Jul 9, 2024 | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener | Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d... | Class II | Smith & Nephew, Inc. |
| Jul 9, 2024 | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener | Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d... | Class II | Smith & Nephew, Inc. |
| May 3, 2024 | EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee rep... | One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP... | Class II | MicroPort Orthopedics Inc. |
| Apr 24, 2024 | smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Ste... | Packaging contained the incorrect size of femoral head from what was displayed on the label. | Class II | Smith & Nephew Inc |
| Mar 6, 2024 | stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty | Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustmen... | Class II | Wright Medical Technology, Inc. |
| Feb 13, 2024 | GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECAR... | DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver ... | Class I | DeRoyal Industries Inc |
| Dec 28, 2023 | AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL,... | The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after ... | Class II | MRP, LLC dba Aquabiliti |
| Nov 22, 2023 | DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 | Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure tran... | Class II | DeRoyal Industries Inc |
| Oct 2, 2023 | Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL... | Due to product outer packaging incorrectly labeled. | Class II | Edge Biologicals Inc |
| Sep 27, 2023 | JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee pros... | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... | Class II | Smith & Nephew, Inc. |
| Sep 27, 2023 | JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 7402926... | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... | Class II | Smith & Nephew, 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 |
| Sep 18, 2023 | DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit | DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Me... | Class II | DeRoyal Industries Inc |
| Aug 31, 2023 | smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, ... | The firm conducting a recall due to a complaint received indicating that a package contained a LE... | Class II | Smith & Nephew 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 |
| Jul 24, 2023 | TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71... | A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL... | Class II | Smith & Nephew, Inc. |
| Jul 24, 2023 | TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71... | A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL... | Class II | Smith & Nephew, Inc. |
| Jul 12, 2023 | CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K | Incorrect Laser Marking - Solera Awl Tip Tap | Class II | Medtronic Sofamor Danek USA, Inc |
| Jun 13, 2023 | Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-... | The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin... | Class II | Wright Medical Technology, 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 |
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.