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 |
|---|---|---|---|---|
| Nov 15, 2016 | SOMATOM Definition AS System, x-ray, tomography, computed Intended to produc... | Software update that provides software and firmware bug-fixes to improve system performance | Class II | Siemens Medical Solutions USA, Inc |
| Nov 15, 2016 | BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Nov 15, 2016 | Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are i... | All lots of modular neck hip prostheses are being recalled due to a higher than anticipated compl... | Class II | Smith & Nephew, Inc. |
| Nov 15, 2016 | ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, St... | The vial cap was mislabeled with the incorrect part number of 855708 but the product description ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 15, 2016 | SOMATOM Definition Edge System, x-ray, tomography, computed Intended to prod... | Software update that provides software and firmware bug-fixes to improve system performance | Class II | Siemens Medical Solutions USA, Inc |
| Nov 15, 2016 | Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) ... | All lots of modular neck hip prostheses are being recalled due to a higher than anticipated compl... | Class II | Smith & Nephew, Inc. |
| Nov 15, 2016 | SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Onl... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Nov 15, 2016 | Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are in... | All lots of modular neck hip prostheses are being recalled due to a higher than anticipated compl... | Class II | Smith & Nephew, Inc. |
| Nov 15, 2016 | CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE,... | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated th... | Class II | Robert Busse & Co. Inc. d.b.a. Busse Hospital D... |
| Nov 15, 2016 | Empowr Knee System Product Usage: Non-porous proximal tibial baseplate im... | A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, ma... | Class II | Encore Medical, Lp |
| Nov 14, 2016 | Cellfina Prep Pack, Part No. CP1 | It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instru... | Class II | Ulthera Inc |
| Nov 14, 2016 | IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cr... | A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Application... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 14, 2016 | Philips Spectral CT Applications supports viewing and analysis of images at e... | A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Application... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Brilliance 64 728232 Computed Tomography X-ray systems intended to produce c... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Ingenuity Core 128 728323 | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cr... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce ... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Brilliance 64 728231 Computed Tomography X-ray systems intended to produce c... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 11, 2016 | Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Inte... | Lack of 510k clearance for design modification. | Class II | Smith & Nephew, Inc. |
| Nov 11, 2016 | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endosco... | An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in ... | Class II | Stryker Sustainability Solutions |
| Nov 11, 2016 | ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 | Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching durin... | Class II | Greatbatch Medical |
| Nov 11, 2016 | Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Sup... | Lack of 510k clearance for design modification. | Class II | Smith & Nephew, Inc. |
| Nov 10, 2016 | ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross... | Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire... | Class II | Medtronic Inc |
| Nov 10, 2016 | Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) P... | Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due t... | Class III | OraSure Technologies, Inc. |
| Nov 10, 2016 | Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile. | Defects: Product may be discolored and brittle resulting in the inability of the user to don the ... | Class II | Halyard Health |
| Nov 9, 2016 | Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product C... | The firm received complaints claiming the dental material failed to set up. As the dental materi... | Class II | Ivoclar Vivadent, Inc. |
| Nov 9, 2016 | Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Produc... | The firm received complaints claiming the dental material failed to set up. As the dental materi... | Class II | Ivoclar Vivadent, Inc. |
| Nov 9, 2016 | GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stry... | A review of packaging revealed the seal integrity of the pouch may be compromised. More specifica... | Class II | Stryker Howmedica Osteonics Corp. |
| Nov 9, 2016 | Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Prod... | Drapes within the affected lots may include a manufacturing variation that prevents convenient re... | Class II | Halyard Health, Inc |
| Nov 9, 2016 | Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spect... | Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Sur... | Class II | Elana, Inc. |
| Nov 9, 2016 | Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 6464... | The firm received complaints claiming the dental material failed to set up. As the dental materi... | Class II | Ivoclar Vivadent, Inc. |
| Nov 9, 2016 | RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System... | Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation ... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 8, 2016 | SWANSON FINGER JOINT #2, Part Number 4700002 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number ... | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled | Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to com... | Class II | Stryker Medical Division of Stryker Corporation |
| Nov 8, 2016 | ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow On... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Ar... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | SWANSON TRAPEZIUM IMPLANT, Part Number 4520002 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | PREMIER EHEC and PREMIER EHEC Bulk. | Internal testing has demonstrated that the indicated kit lots produce false positive results when... | Class II | Meridian Bioscience Inc |
| Nov 8, 2016 | EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnCon... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | INBONE STEM, TIBIAL, TOP, Part Number 200011901 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | SWANSON FINGER JOINT #1, Part Number 4700001 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow ... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Inser... | DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision Syste... | Class II | DePuy Orthopaedics, 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.