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 |
|---|---|---|---|---|
| Aug 23, 2016 | Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, ... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packag... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 22, 2016 | Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast bi... | Incorrect label on the Sertera Biopsy Kit | Class II | Hologic, Inc |
| Aug 22, 2016 | The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom ... | Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement ... | Class II | EKOS Corporation |
| Aug 19, 2016 | Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage:... | Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ra... | Class II | Panoramic Rental Corp. |
| Aug 19, 2016 | The Introes Pocket Bougie is an endotracheal tube introducer. The device is a... | The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break du... | Class II | Brathwaites Oliver Medical |
| Aug 18, 2016 | NIO-A / NIO-P is an instant IO access device comprises housing with spring lo... | WaisMed received a report in which during the operation of the NIO-A, the needle was not released... | Class II | Waismed Ltd |
| Aug 18, 2016 | Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent Syste... | Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was id... | Class II | NOVADAQ TECHNOLOGIES INC. |
| Aug 18, 2016 | Monaco RTP System Used to make treatment plans for patients with prescript... | In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the con... | Class II | Elekta, Inc. |
| Aug 18, 2016 | HexaPOD evo RT System Product Usage: The intended use of the device is th... | Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaP... | Class II | Elekta, Inc. |
| Aug 18, 2016 | Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0... | Stryker Orthopaedics has received reports of the thread length protruding past the dome of the ac... | Class II | Stryker Howmedica Osteonics Corp. |
| Aug 17, 2016 | Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: ... | Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potentia... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Aug 17, 2016 | HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and... | Foreign material found within the driveline connector of the HVAD Pump that could cause increased... | Class I | HeartWare, Inc |
| Aug 16, 2016 | Pathfast D-Dimer, Reference number: PF1051-KUS | Two complaints were received about decrease in sensitivity (control value and/or calibration valu... | Class II | Lsi Medience Corporation |
| Aug 16, 2016 | Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This pro... | Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Mor... | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2016 | CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG5... | Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Syst... | Class II | Biosense Webster, Inc. |
| Aug 15, 2016 | Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribut... | A reagent stability issue (still under investigation) causes less separation in the calibration c... | Class II | Microgenics Corporation |
| Aug 15, 2016 | Pentax Video Colonoscope is intended to be used with a PENTAX video processor... | Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that... | Class II | Pentax of America Inc |
| Aug 15, 2016 | Pentax Video Gastroscope is intended to be used with a Pentax video processor... | PENTAX Medical is initiating this field action to provide customers that have purchased the affec... | Class II | Pentax of America Inc |
| Aug 15, 2016 | BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, ... | Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk... | Class II | Prismatik Dentalcraft, Inc |
| Aug 12, 2016 | Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contras... | Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due ... | Class II | Merit Medical Systems, Inc. |
| Aug 12, 2016 | Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Co... | The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been return... | Class II | Sorin Group USA, Inc. |
| Aug 12, 2016 | Medtronic, Evera Implantable Cardioverter Defibrillators: Product Mo... | 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Aug 12, 2016 | Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part n... | Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery... | Class II | Sorin Group USA, Inc. |
| Aug 12, 2016 | Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. ... | Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug... | Class II | Ortho Kinematics, Inc |
| Aug 12, 2016 | Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product... | 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Aug 12, 2016 | PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732... | A defect component of the Compano reader power supply can cause the power supply to burn and some... | Class II | Philips Electronics North America Corporation |
| Aug 12, 2016 | The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecti... | Post Market Surveillance cases reported to Maquet showing instances in which the welded joint bet... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Aug 12, 2016 | NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation... | Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, an... | Class II | Novarad Corporation |
| Aug 12, 2016 | Arthrex Suture Washer | The device was assembled incorrectly. Suture and washer were not assembled; components were place... | Class III | Arthrex, Inc. |
| Aug 11, 2016 | Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part... | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec... | Class II | Synergetics Inc |
| Aug 11, 2016 | RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides ... | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o... | Class II | Ortho-Clinical Diagnostics |
| Aug 11, 2016 | 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged ... | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec... | Class II | Synergetics Inc |
| Aug 11, 2016 | Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 103... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides ... | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o... | Class II | Ortho-Clinical Diagnostics |
| Aug 11, 2016 | DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surg... | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe ... | Class II | DeRoyal Industries Inc |
| Aug 11, 2016 | VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides ... | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o... | Class II | Ortho-Clinical Diagnostics |
| Aug 11, 2016 | Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom s... | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe ... | Class II | DeRoyal Industries Inc |
| Aug 11, 2016 | 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Prod... | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec... | Class II | Synergetics Inc |
| Aug 11, 2016 | Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): ... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides... | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o... | Class II | Ortho-Clinical Diagnostics |
| Aug 11, 2016 | RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 700... | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec... | Class II | Synergetics Inc |
| Aug 11, 2016 | Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 10, 2016 | Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Produ... | Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopot... | Class II | Blackrock Microsystems, LLC |
| Aug 10, 2016 | Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes withi... | Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopot... | Class II | Blackrock Microsystems, LLC |
| Aug 10, 2016 | Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, 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.