Browse Device Recalls
2,729 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,729 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 2,729 FDA device recalls in 2014.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 22, 2014 | Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The de... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The de... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are int... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management ... | RAPIDComm¿ 5.0 Screen Layout will display incorrect test names | Class III | Siemens Healthcare Diagnostics Inc |
| May 22, 2014 | Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are int... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended ... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: ... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The de... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The de... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The ... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are ... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The de... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The ... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are i... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue I... | IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume... | Class II | Philips Medical Systems, Inc. |
| May 22, 2014 | Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are int... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are int... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The d... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended ... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 21, 2014 | Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical ... | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... | Class II | Intuitive Surgical, Inc. |
| May 21, 2014 | cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filt... | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... | Class II | Roche Diagnostics Operations, Inc. |
| May 21, 2014 | Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci ... | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... | Class II | Intuitive Surgical, Inc. |
| May 21, 2014 | Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinc... | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... | Class II | Intuitive Surgical, Inc. |
| May 21, 2014 | Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard ... | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... | Class II | Intuitive Surgical, Inc. |
| May 21, 2014 | Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S Sys... | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... | Class II | Intuitive Surgical, Inc. |
| May 21, 2014 | cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filt... | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... | Class II | Roche Diagnostics Operations, Inc. |
| May 21, 2014 | Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System an... | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... | Class II | Intuitive Surgical, Inc. |
| May 21, 2014 | Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da ... | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... | Class II | Intuitive Surgical, Inc. |
| May 21, 2014 | Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System... | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... | Class II | Intuitive Surgical, Inc. |
| May 21, 2014 | Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S Syst... | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... | Class II | Intuitive Surgical, Inc. |
| May 21, 2014 | Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a sur... | Integra has identified through an investigation of complaints that there may be the potential for... | Class II | SeaSpine Inc |
| May 21, 2014 | Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software... | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... | Class II | Roche Diagnostics Operations, Inc. |
| May 21, 2014 | Connection QRG for the da Vinci Standard Surgical System; da Vinci S System... | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... | Class II | Intuitive Surgical, Inc. |
| May 21, 2014 | System Manual for the da Vinci Standard Surgical System; da Vinci S System an... | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... | Class II | Intuitive Surgical, Inc. |
| May 21, 2014 | RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex ... | Product was packaged with a straight catheter rather than the correct coude (curved) catheter. | Class II | Teleflex Medical |
| May 21, 2014 | BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catal... | A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 322... | Class III | Becton Dickinson & Co. |
| May 21, 2014 | IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da... | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... | Class II | Intuitive Surgical, Inc. |
| May 21, 2014 | Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intrao... | Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intra... | Class II | Brainlab AG |
| May 20, 2014 | ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15"... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, 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.