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 |
|---|---|---|---|---|
| Jul 10, 2014 | Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Nu... | Zimmer received a trend of complaints indicating corrosion of product. | Class II | Zimmer, Inc. |
| Jul 10, 2014 | Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Po... | Excessive weight on the table will cause tables with the affected component to drop into the Tren... | Class II | Medical Positioning Inc |
| Jul 10, 2014 | Medical Positioning Rapid Response HUT table, Powered Medical Examination tab... | Excessive weight on the table will cause tables with the affected component to drop into the Tren... | Class II | Medical Positioning Inc |
| Jul 10, 2014 | RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, S... | Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date... | Class III | Teleflex Medical |
| Jul 10, 2014 | Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Nu... | Zimmer received a trend of complaints indicating corrosion of product. | Class II | Zimmer, Inc. |
| Jul 10, 2014 | Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part N... | Zimmer received a trend of complaints indicating corrosion of product. | Class II | Zimmer, Inc. |
| Jul 10, 2014 | Medical Positioning Rapid Response HUT table, Powered Medical Examination tab... | Excessive weight on the table will cause tables with the affected component to drop into the Tren... | Class II | Medical Positioning Inc |
| Jul 10, 2014 | Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Nu... | Zimmer received a trend of complaints indicating corrosion of product. | Class II | Zimmer, Inc. |
| Jul 9, 2014 | QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a softw... | The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under spe... | Class II | Philips Ultrasound, Inc. |
| Jul 9, 2014 | Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7... | An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collim... | Class II | Carestream Health, Inc. |
| Jul 9, 2014 | The Hulka Clip is a sterile packaged medical device that carries a two year e... | Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51... | Class II | Richard Wolf Medical Instruments Corp. |
| Jul 9, 2014 | Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscop... | Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates ... | Class II | Teleflex Medical |
| Jul 9, 2014 | Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Pie... | The temperature probe does not properly connect to the temperature port. | Class II | Teleflex Medical |
| Jul 9, 2014 | Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene ... | Nanosphere Inc. has recently determined through four customer complaints that a small number of V... | Class II | Nanosphere, Inc. |
| Jul 9, 2014 | Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat.... | Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of rev... | Class II | Integra LifeSciences Corp. |
| Jul 9, 2014 | Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory... | The temperature probe does not properly connect to the temperature port. | Class II | Teleflex Medical |
| Jul 9, 2014 | QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a sof... | The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under spe... | Class II | Philips Ultrasound, Inc. |
| Jul 8, 2014 | Philips Medical Systems Allura Xper FD20C Radiological Imaging with software ... | Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handli... | Class II | Philips Medical Systems, Inc. |
| Jul 8, 2014 | Philips Medical Systems Allura Xper FD20C with software version R8.2.O Syste... | Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handli... | Class II | Philips Medical Systems, Inc. |
| Jul 8, 2014 | Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a ... | Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non... | Class II | Gyrus Medical, Inc |
| Jul 7, 2014 | VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediat... | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... | Class I | Smiths Medical ASD, Inc. |
| Jul 7, 2014 | 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric ... | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... | Class I | Smiths Medical ASD, Inc. |
| Jul 7, 2014 | H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric... | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... | Class I | Smiths Medical ASD, Inc. |
| Jul 7, 2014 | Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is ... | Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to comp... | Class II | Stryker Spine |
| Jul 7, 2014 | H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediat... | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... | Class I | Smiths Medical ASD, Inc. |
| Jul 7, 2014 | H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... | Class I | Smiths Medical ASD, Inc. |
| Jul 7, 2014 | GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor inte... | Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is conn... | Class II | GE Healthcare, LLC |
| Jul 7, 2014 | Stryker Aria Implant Inserter, REF 48758500, This instrument is part of ... | Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to comp... | Class II | Stryker Spine |
| Jul 7, 2014 | Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm... | Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and c... | Class II | Innovasis, Inc |
| Jul 7, 2014 | Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF ... | It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 7, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VIT... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative,... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit | The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... | Class I | Smiths Medical ASD, Inc. |
| Jul 5, 2014 | VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medica... | Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, t... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| Jul 4, 2014 | AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro ... | Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, f... | Class II | Advandx Inc |
| Jul 3, 2014 | Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessori... | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... | Class II | Codman & Shurtleff, Inc. |
| Jul 3, 2014 | IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS i... | In specific situation a partially truncated file may be written to the IntelePACS server. This p... | Class II | Intelerad Medical Systems |
| Jul 3, 2014 | Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product... | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... | Class II | Codman & Shurtleff, Inc. |
| Jul 3, 2014 | Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessor... | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... | Class II | Codman & Shurtleff, Inc. |
| Jul 3, 2014 | Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 8... | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... | Class II | Codman & Shurtleff, Inc. |
| Jul 3, 2014 | CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonograph... | Unsealed pouches. | Class II | CooperSurgical, Inc. |
| Jul 3, 2014 | Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ C... | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... | Class II | Codman & Shurtleff, Inc. |
| Jul 3, 2014 | Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Access... | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... | Class II | Codman & Shurtleff, Inc. |
| Jul 3, 2014 | Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Cert... | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... | Class II | Codman & Shurtleff, Inc. |
| Jul 3, 2014 | Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82... | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... | Class II | Codman & Shurtleff, Inc. |
| Jul 3, 2014 | BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 m... | BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, r... | Class II | Becton Dickinson & Company |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira Inc. |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira Inc. |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira 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.