Browse Device Recalls
2,055 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,055 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 2,055 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 7, 2015 | RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD18... | EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particu... | Class II | Eizo Corporation |
| Jul 3, 2015 | nordicICE v 2.3.14 nordicICE is an image processing software package to be... | The bug causes BOLD activation maps to be visualized as overlays without taking the coregistrati... | Class II | NordicNeuroLab AS |
| Jun 15, 2015 | Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable an... | The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. The fi... | Class II | Etac Supply Center Ab |
| Jun 15, 2015 | Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biop... | Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the... | Class II | Mermaid Medical A/S |
| May 27, 2015 | RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Br... | Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction dista... | Class II | RAYSEARCH LABORATORIES AB |
| May 27, 2015 | PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware v... | In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proto... | Class II | PTW-Freiburg |
| May 14, 2015 | The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Opti... | The pin which maintains the knob button, may disconnect and become lost. This may result in a de... | Class II | BIOMET FRANCE S.A.R.L. |
| May 8, 2015 | BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation... | Instances of data sets not being accurately registered to the patient anatomy were observed. | Class II | Brainlab AG |
| May 6, 2015 | VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique... | The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank lab... | Class III | ORTHO-CLINICAL DIAGNOSTICS |
| May 5, 2015 | Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. | The Astral device allows clinicians to disable all alarms including those that detect circuit dis... | Class II | ResMed Ltd. |
| May 2, 2015 | NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e,... | It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1... | Class II | Neusoft Medical Systems Co., Ltd. |
| Apr 19, 2015 | Tibial Alignment Guide; Orthopedic Stereotaxic Instrument; | Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignmen... | Class II | Zimmer CAS |
| Apr 17, 2015 | MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) | The operator console allows users to deliver therapeutic radiation to patients even though a spec... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| Mar 30, 2015 | ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a s... | Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility tha... | Class II | Baylis Medical Corp * |
| Mar 6, 2015 | ExacTrac 6.x. is software used to place patients at an accurately defined poi... | ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the... | Class II | Brainlab AG |
| Feb 24, 2015 | Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electro... | The electrodes may fail to transmit signals. | Class II | Leonhard Lang Medizintechnik GmbH |
| Feb 20, 2015 | GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog... | Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of t... | Class II | Pega Medical Inc. |
| Feb 2, 2015 | COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, ... | Error in the software. During internal tests of the current development version of the Compass ... | Class II | Iba Dosimetry Gmbh |
| Jan 22, 2015 | FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3... | Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of t... | Class II | Carl Zeiss Meditec AG |
| Jan 16, 2015 | The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system.... | The recommended sterilization and drying parameters are not effective to achieve the minimum requ... | Class II | Brainlab AG |
| Dec 19, 2014 | McKesson Cardiology ECG Management It is a software application designed t... | An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG ... | Class II | McKesson Israel Ltd. |
| Dec 17, 2014 | Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in ... | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... | Class II | Zimmer Gmbh |
| Dec 17, 2014 | CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in ske... | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... | Class II | Zimmer Gmbh |
| Dec 17, 2014 | Metasul Femoral Head - A modular head component is used in conjunction with a... | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... | Class II | Zimmer Gmbh |
| Dec 17, 2014 | Metasul Femoral Head - indicated for total hip arthroplasty for treatment of... | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... | Class II | Zimmer Gmbh |
| Dec 17, 2014 | CoCr Femoral Head - A modular head component is used in conjunction with a fe... | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in sur... | Class II | Zimmer Gmbh |
| Dec 15, 2014 | nordicTumorEx 1.0 nordicTumorEx is an image processing software package ... | An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... | Class II | NordicNeuroLab AS |
| Dec 3, 2014 | Rotoprone Therapy System. The Rotoprone Therapy System is an advanced pati... | The recalled devices labeling and instructions for use contain unapproved medical claims. | Class II | Arjo Hospital Equipment AB |
| Dec 3, 2014 | RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kineti... | The recalled devices labeling and instructions for use contain unapproved medical claims. | Class II | Arjo Hospital Equipment AB |
| Dec 3, 2014 | VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique ... | If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to moni... | Class II | INNOKAS MEDICAL OY |
| Dec 3, 2014 | TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Crit... | The recalled devices labeling and instructions for use contain unapproved medical claims. | Class II | Arjo Hospital Equipment AB |
| Dec 2, 2014 | VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-... | Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (Ex... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| 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 7, 2014 | Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care | Unintended treatment termination could result from a keypad malfunction in some situations. The d... | Class II | Breas Medical AB |
| 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 |
| Nov 3, 2014 | PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, ceme... | Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotati... | Class II | Zimmer CAS |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility T... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 6, 2014 | Synthes Inflation System (03.804.4135) Product Usage: Inflation system i... | Additional instructions for use due to inability to raise the pressure above 10 atm during inflat... | Class II | PEROUSE MEDICAL |
| Oct 6, 2014 | Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device i... | Additional instructions for use due to inability to raise the pressure above 10 atm during inflat... | Class II | PEROUSE MEDICAL |
| Sep 25, 2014 | COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear ... | Error in the software. A deviation between reconstructed and planned dose distribution may not b... | Class II | Iba Dosimetry Gmbh |
| Sep 17, 2014 | nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic... | An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... | Class II | NordicNeuroLab AS |
| Sep 12, 2014 | nordicICE 2.3.14 Image processing software package used by trained profess... | An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... | Class II | NordicNeuroLab AS |
| Sep 11, 2014 | Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ... | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... | Class II | The Binding Site Group, Ltd. |
| Sep 11, 2014 | Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II... | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... | Class II | The Binding Site Group, Ltd. |
| Sep 11, 2014 | ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.... | 17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may ex... | Class II | Abbott Ireland Diagnostics Division |
| Sep 11, 2014 | Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"600... | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... | Class II | The Binding Site Group, Ltd. |
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.