Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 8, 2019 | Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... | Class II | Gyrus ACMI, Inc. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, ... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4... | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... | Class II | Gyrus ACMI, Inc. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, ... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, P... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A P... | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... | Class II | Gyrus ACMI, Inc. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 7, 2019 | Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-6... | The heated tube sets were consistently leaking and detaching from the cassette. | Class II | Stryker Corporation |
| Mar 7, 2019 | Atellica IM 1300 Analyzer, Material Number 11066001 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Atellica Sample Handler Prime, Material Number 11069001 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Atellica IM 1600 Analyzer, Material Number 11066000 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010 | The luer could break and cause the device to leak or break off and get stuck in the fistula needl... | Class II | Becton Dickinson & Company |
| Mar 7, 2019 | BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608 | BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle... | Class II | Becton Dickinson & Company |
| Mar 7, 2019 | Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R7... | Potential performance issues in the Alinity-ci software version 2.5.1 | Class II | Abbott Gmbh & Co. KG |
| Mar 7, 2019 | Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-04... | The heated tube sets were consistently leaking and detaching from the cassette. | Class II | Stryker Corporation |
| Mar 7, 2019 | Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO ... | The heated tube sets were consistently leaking and detaching from the cassette. | Class II | Stryker Corporation |
| Mar 7, 2019 | FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126,... | Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected bloo... | Class II | BioFire Diagnostics, LLC |
| Mar 6, 2019 | TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877 | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration iss... | Class II | Acclarent, Inc. |
| Mar 6, 2019 | AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component... | Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within th... | Class II | PROCEPT BIOROBOTICS CORPORATION |
| Mar 6, 2019 | IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program t... | When a patient is selected in the patient data and another patient is selected prior to the displ... | Class II | Topcon Medical Systems, Inc. |
| Mar 6, 2019 | TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891 | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration iss... | Class II | Acclarent, Inc. |
| Mar 6, 2019 | TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884 | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration iss... | Class II | Acclarent, Inc. |
| Mar 6, 2019 | FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC... | Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified. | Class II | BioFire Diagnostics, LLC |
| Mar 5, 2019 | Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07 | The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the spec... | Class II | Becton Dickinson & Company |
| Mar 5, 2019 | Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled ... | Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events invo... | Class II | Fenwal Inc |
| Mar 5, 2019 | Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07 | The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the spec... | Class II | Becton Dickinson & Company |
| Mar 4, 2019 | Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Produ... | The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury. | Class III | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Mar 3, 2019 | MRIdian Linac Radiation Therapy System Model 10000 and 20000 | Issue with transferring treatment regiment from one system to another. Adequate instructions for... | Class II | Viewray, Inc. |
| Mar 1, 2019 | BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use i... | Leak from the septum assembly or the canister may burst under high pressure which could result in... | Class II | Becton Dickinson & Company |
| Mar 1, 2019 | Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - ... | Temperature indicator may have changed color to dark gray or black prior to shipment. Change in c... | Class II | Integra Limited |
| Mar 1, 2019 | Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - ... | Temperature indicator may have changed color to dark gray or black prior to shipment. Change in c... | Class II | Integra Limited |
| Mar 1, 2019 | Laparotomy Sponge with the following product description and model numbers: ... | Potential lack of sterility assurance | Class II | Medical Action Industries Inc |
| Mar 1, 2019 | Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Tita... | Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for th... | Class II | Zimmer Biomet, Inc. |
| Mar 1, 2019 | Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - P... | Temperature indicator may have changed color to dark gray or black prior to shipment. Change in c... | Class II | Integra Limited |
| Mar 1, 2019 | Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Tita... | Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for th... | Class II | Zimmer Biomet, Inc. |
| Mar 1, 2019 | Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an opti... | Small black plastic particle was observed in the left ventricle during implant procedure. | Class II | Thoratec Corp. |
| Feb 28, 2019 | Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MR... | The locking plate may be missing from the system, which may result in unexpected stand/table tilt... | Class II | Philips North America, LLC |
| Feb 28, 2019 | Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory inst... | Lack of an adequate sterilization validation | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2019 | URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: Th... | The locking plate may be missing from the system, which may result in unexpected stand/table tilt... | Class II | Philips North America, LLC |
| Feb 28, 2019 | MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 P... | The locking plate may be missing from the system, which may result in unexpected stand/table tilt... | Class II | Philips North America, LLC |
| Feb 28, 2019 | SmartSite Syringe Administration Set-Product Package Size 50, Catalog Numbe... | Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infu... | Class I | Becton Dickinson & Company |
| Feb 28, 2019 | Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product ... | The locking plate may be missing from the system, which may result in unexpected stand/table tilt... | Class II | Philips North America, LLC |
| Feb 28, 2019 | MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a mul... | The locking plate may be missing from the system, which may result in unexpected stand/table tilt... | Class II | Philips North America, LLC |
| Feb 27, 2019 | Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF ... | The device label incorrectly states that the device is sterile. This product is an externally app... | Class III | Teleflex Medical |
| Feb 27, 2019 | McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numb... | Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA... | Class III | Cypress Medical Products LLC |
| Feb 27, 2019 | MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with... | Administration sets leaked at the filter. | Class II | Zevex Incorporated (dba MOOG Medical Devices Gr... |
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.