Browse Device Recalls
2,522 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,522 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 2,522 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 25, 2014 | Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Ma... | Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x ... | Class II | Zimmer, Inc. |
| Nov 24, 2014 | Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number... | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... | Class II | Arthrosurface, Inc. |
| Nov 24, 2014 | Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: ... | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... | Class II | Arthrosurface, Inc. |
| Nov 24, 2014 | Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8... | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... | Class II | Arthrosurface, Inc. |
| Nov 24, 2014 | Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Num... | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... | Class II | Arthrosurface, Inc. |
| Nov 24, 2014 | Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number... | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... | Class II | Arthrosurface, Inc. |
| Nov 21, 2014 | Bone Screw, self-tapping The Trilogy shells are available in three configura... | Analysis of returned complaint devices, product in inventory, and device manufacturing records ha... | Class II | Zimmer Manufacturing B.V. |
| Nov 21, 2014 | Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek ... | Affected product may have compromised sterility due to packaging defects. It was determined that ... | Class II | Atricure Inc |
| Nov 19, 2014 | Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, ... | MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tid... | Class II | Philips Medical Systems, Inc. |
| Nov 19, 2014 | HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J,... | Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadverte... | Class II | Philips Medical Systems, Inc. |
| Nov 13, 2014 | FLUTTER Percussor respiratory device, packaged one unit per clear plastic pac... | Customer notification that the device may be difficult to open or close. | Class II | Aptalis Pharmatech Inc. |
| Nov 7, 2014 | Ceramic Femoral Head. Intended for use in total hip arthroplasty applica... | Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (... | Class II | DePuy Orthopaedics, Inc. |
| Nov 5, 2014 | Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... | Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... | Class II | Toshiba American Medical Systems Inc |
| Nov 5, 2014 | Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps... | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... | Class II | Philips Ultrasound, Inc. |
| Nov 5, 2014 | EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.... | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... | Class II | Philips Ultrasound, Inc. |
| Nov 5, 2014 | Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... | Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... | Class II | Toshiba American Medical Systems Inc |
| Nov 5, 2014 | EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.... | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... | Class II | Philips Ultrasound, Inc. |
| Nov 5, 2014 | Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10... | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... | Class II | Philips Ultrasound, Inc. |
| Nov 4, 2014 | McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items... | The blade retaining clip may be difficult to engage and thereby increase the possibility of a bl... | Class II | Aircraft Medical Limited |
| Oct 23, 2014 | Nerve Block Tray (Nerve Block convenience kit) | According to the recall notice received from Hospira, the recall was initiated due to a confirmed... | Class II | Centurion Medical Products Corporation |
| Oct 23, 2014 | Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit) | According to the recall notice received from Hospira, the recall was initiated due to a confirmed... | Class II | Centurion Medical Products Corporation |
| Oct 23, 2014 | Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit) | According to the recall notice received from Hospira, the recall was initiated due to a confirmed... | Class II | Centurion Medical Products Corporation |
| Oct 23, 2014 | Diagnostic Imaging Tray (General Surgery convenience kit) | According to the recall notice received from Hospira, the recall was initiated due to a confirmed... | Class II | Centurion Medical Products Corporation |
| Oct 17, 2014 | INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0... | An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxid... | Class II | INO Therapeutics (dba Ikaria) |
| Oct 10, 2014 | The 5085 is a general surgical table with high patient weight capacity, exten... | The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignmen... | Class II | Steris Corporation |
| Oct 9, 2014 | Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is i... | Cleaning process validation failure. | Class II | Zimmer, Inc. |
| Oct 8, 2014 | Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in ... | Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for ... | Class II | Edwards Lifesciences, LLC |
| Oct 7, 2014 | The Persona Tibial Articular Surface Inserter is a sterilizable instrument in... | Affected product did not undergo heat treatment hardening step leading to the potential for defor... | Class II | Zimmer, Inc. |
| Oct 7, 2014 | Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone baske... | The product is non-sterile. | Class II | C.R. Bard, Inc. |
| Oct 1, 2014 | APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plate... | A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of... | Class II | Medartis, Inc. |
| Oct 1, 2014 | Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in ... | A software issue may lead to ventilator inoperative situations. | Class I | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Sep 17, 2014 | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... | Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... | Class II | Boston Scientific CRM Corp |
| Sep 17, 2014 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... | Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... | Class II | Boston Scientific CRM Corp |
| Sep 16, 2014 | Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, ... | Particulate matter found inside the fluid path. | Class I | Baxter Healthcare Corp |
| Sep 16, 2014 | Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogen... | Particulate matter found inside the fluid path. | Class I | Baxter Healthcare Corp |
| Sep 15, 2014 | Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage Sys... | tubing within the system that drains CSF may leak or disconnect from the joints and may result in... | Class II | Codman & Shurtleff, Inc. |
| Sep 15, 2014 | Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage Sy... | tubing within the system that drains CSF may leak or disconnect from the joints and may result in... | Class II | Codman & Shurtleff, Inc. |
| Sep 15, 2014 | Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System)... | tubing within the system that drains CSF may leak or disconnect from the joints and may result in... | Class II | Codman & Shurtleff, Inc. |
| Aug 19, 2014 | 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow C... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 19, 2014 | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 C... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 19, 2014 | 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Contr... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 19, 2014 | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 C... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 15, 2014 | Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174A... | Medtronic has decided to discontinue production and distribution of this low-volume product. | Class II | Medtronic Cardiovascular Surgery-the Heart Valv... |
| Aug 14, 2014 | SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The ... | SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because t... | Class II | Sam Medical Products |
| Aug 13, 2014 | RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for pat... | Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval noti... | Class II | Smith & Nephew, Inc. |
| Aug 13, 2014 | V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (... | Reports of deterioration of material covering the articulating section of the V5Ms transesophagea... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 12, 2014 | eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA... | Two (2) failures of the spring link components within the articulated arm assembly. The spring li... | Class II | Gendex Corp |
| Aug 7, 2014 | PERSONA The Personalized Knee System Tibial Articular Surface Provisional Lef... | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... | Class II | Zimmer, Inc. |
| Aug 7, 2014 | PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial ... | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... | Class II | Zimmer, Inc. |
| Aug 7, 2014 | PERSONA The Personalized Knee System Constrained Tibial Articular Surface Pro... | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... | Class II | Zimmer, 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.