Browse Device Recalls
3,029 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,029 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 3,029 FDA device recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 21, 2016 | EkoSonic Endovascular System, Catalog Number 500-56112. It consists of thr... | The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug... | Class II | EKOS Corporation |
| Jan 21, 2016 | Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Con... | 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were pa... | Class II | Covidien LLC |
| Jan 21, 2016 | Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, ... | Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 month... | Class II | Biomet France SARL |
| Jan 21, 2016 | Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended fo... | During a review of the packaging, it was determined that the seal integrity of the pouch may be d... | Class II | Stryker Howmedica Osteonics Corp. |
| Jan 21, 2016 | Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended... | During a review of the packaging, it was determined that the seal integrity of the pouch may be d... | Class II | Stryker Howmedica Osteonics Corp. |
| Jan 21, 2016 | Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended f... | During a review of the packaging, it was determined that the seal integrity of the pouch may be d... | Class II | Stryker Howmedica Osteonics Corp. |
| Jan 20, 2016 | LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Prod... | LeadCare II Test Kits controls out of range | Class II | Magellan Diagnostics, Inc. |
| Jan 20, 2016 | Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonos... | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb P... | The recliners were shipped without the foot rest ottoman linkage side shields, which could result... | Class II | Hill-Rom, Inc. |
| Jan 20, 2016 | Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric... | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotac... | Complaints were received reporting the system would freeze/shut down while in Fulgurate mode. | Class II | Zimmer Biomet, Inc. |
| Jan 20, 2016 | Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use i... | The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manuall... | Class II | AGFA Healthcare Corp. |
| Jan 20, 2016 | Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatri... | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70... | Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. | Class II | Cook Inc. |
| Jan 20, 2016 | Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 20, 2016 | Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope | If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assem... | Class II | Integrated Medical Systems Inc |
| Jan 19, 2016 | HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boo... | Products are marketed without a cleared 510k. | Class II | Ergoactives, Llc |
| Jan 19, 2016 | Convenience Kits from Centurion that contain an In-Vision- Plus Needleless I... | Convenience Kits contain an In-Vision-Plus Needleless IV Connector, code RYM5001 that is being re... | Class II | Centurion Medical Products Corporation |
| Jan 19, 2016 | Patient transport Shuttle with Trendelenburg quick adjustment function (Jupit... | Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a... | Class II | Trumpf Medical Systems, Inc. |
| Jan 19, 2016 | CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Pe... | The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HI... | Class III | Sorin Group USA, Inc. |
| Jan 18, 2016 | A Picture Archiving and Communication System (PACS) intended to display, proc... | To inform users about the possible incorrect values for Distance Measurements when using certain ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 18, 2016 | LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SI... | The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, s... | Class II | Smith & Nephew, Inc. |
| Jan 18, 2016 | Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by ... | This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x... | Class II | Sedecal S.A. |
| Jan 18, 2016 | Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 In... | On the label calcium (Ca) listed in the right upper corner of the label (red background) incorre... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jan 18, 2016 | Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbi... | Software Issue | Class II | Philips Respironics |
| Jan 18, 2016 | V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro ... | Instrument stopped working due to a software lockup, and no patient results are produced. | Class II | Vital Scientific N.V. |
| Jan 18, 2016 | CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Descript... | Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recomm... | Class III | Lab Vision Corporation |
| Jan 15, 2016 | Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Int... | Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certai... | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jan 15, 2016 | 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Powe... | The product is labeled with an expiration date that is past its shelf life. | Class II | Spectranetics Corp. |
| Jan 15, 2016 | OraQuick HCV Visual Reference Panel Intended to assist new operation in b... | OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Ant... | Class III | OraSure Technologies, Inc. |
| Jan 15, 2016 | Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated fo... | Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configu... | Class II | Mako Surgical Corporation |
| Jan 15, 2016 | Universal Battery Charger II (UBC II) | The device is reported to enter safe mode and is no longer able to charge batteries. | Class II | The Anspach Effort, Inc. |
| Jan 15, 2016 | Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product... | Customers reported issues when scanning medications with the scanners. When a user scans a medic... | Class II | CareFusion 303, 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.