Browse Device Recalls
2,907 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,907 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 2,907 FDA device recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 16, 2015 | PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CON... | The term DORSAL was laser etched on the incorrect side on some of the angled handles. | Class II | Wright Medical Technology, Inc. |
| Apr 16, 2015 | PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONT... | The term DORSAL was laser etched on the incorrect side on some of the angled handles. | Class II | Wright Medical Technology, Inc. |
| Apr 16, 2015 | Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 370... | Medtronic is providing Important information regarding extension handling during implant procedur... | Class II | Medtronic Neuromodulation |
| Apr 15, 2015 | ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcryS... | There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) ... | Class I | Alcon Research, Ltd. |
| Apr 14, 2015 | The Integra Licox Pt02 Monitors are compact, portable device for use with Pre... | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 ... | Class II | Integra LifeSciences Corp. |
| Apr 14, 2015 | MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer applicat... | The MYLA¿ server could slow down due to the volume (weight) of the data to manage and it could... | Class II | bioMerieux, Inc. |
| Apr 14, 2015 | Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24,... | Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail... | Class II | Nihon Kohden America Inc |
| Apr 14, 2015 | EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardi... | When EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to "Metric" and... | Class II | Philips Ultrasound, Inc. |
| Apr 14, 2015 | EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardi... | When EPIQ 7 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to "Metric" and... | Class II | Philips Ultrasound, Inc. |
| Apr 14, 2015 | Philips Healthcare Brilliance 64 Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 14, 2015 | The Integra Camino ICP Monitor is a compact, portable device for use with Pre... | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 M... | Class II | Integra LifeSciences Corp. |
| Apr 14, 2015 | Philips Healthcare Ingenuity CT Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 14, 2015 | The Integra Licox Pt02 Monitors are compact, portable device for use with Pre... | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 ... | Class II | Integra LifeSciences Corp. |
| Apr 14, 2015 | Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 14, 2015 | AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray... | If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 14, 2015 | KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Produc... | The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adult... | Class II | Halyard Health, Inc |
| Apr 14, 2015 | Philips Healthcare Ingenuity Core Computed Tomography X-ray system | During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... | Class II | Philips Electronics North America Corporation |
| Apr 13, 2015 | GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5... | Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibil... | Class II | Verathon, Inc. |
| Apr 13, 2015 | SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system,... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting s... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shapi... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bon... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting sh... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. C... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radi... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cut... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cut... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bon... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bo... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an is... | Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on Uni... | Class II | Beckman Coulter Inc. |
| Apr 13, 2015 | ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting sha... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | Brilliance iCT Computed Tomography X-ray system | A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 13, 2015 | ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutti... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shapin... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cu... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including sp... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fl... | Study and all acquired images deleted when using systems with software version VE10E. Acquisitio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2015 | ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expo... | Small sized specula were incorrectly packaged in printed bags for the medium sized speculum | Class II | CooperSurgical, Inc. |
| Apr 13, 2015 | ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting ... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shapin... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting s... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, Inc. |
| Apr 13, 2015 | ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting sh... | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... | Class II | The Anspach Effort, 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.