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 |
|---|---|---|---|---|
| Sep 11, 2014 | Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Produ... | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... | Class II | The Binding Site Group, Ltd. |
| Sep 11, 2014 | MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is inte... | 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 Human lgG1& lgG2 Antisera, lgG3 & 4 L... | 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 kit for use on the Beckman Coulter AU" series This kit ... | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... | Class II | The Binding Site Group, Ltd. |
| Sep 1, 2014 | Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Inte... | The firm received complaints regarding multiple mattresses were showing failures resulting in pre... | Class II | Arjo Hospital Equipment AB |
| Aug 28, 2014 | TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Po... | Motion Concepts identified that there is a possibility of knee support failure occurring through ... | Class II | Motion Concepts |
| Aug 11, 2014 | ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. ... | Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing tha... | Class III | ELITech Clinical Systems SAS |
| Aug 6, 2014 | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitati... | VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Aug 6, 2014 | MobileDiagnost wDR motorized portable diagnostic X-ray systems. | Reports of unexpected movement. | Class II | Sedecal S.A. |
| Aug 3, 2014 | Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). ... | suction canister lids may have occluded ports. | Class II | EMG Technology Co., Ltd. |
| Jul 28, 2014 | Minstrel (with scale) Product Usage: is a mobile passive hoist. It is inte... | ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. The... | Class II | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Jul 16, 2014 | VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot ... | Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 1... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| 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... |
| Jun 25, 2014 | The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a pol... | A potential splitting of the surface treatment of the thread ends on certain sutures has recently... | Class II | Peters Surgical |
| Jun 25, 2014 | The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are compos... | A potential splitting of the surface treatment of the thread ends on certain sutures has recently... | Class II | Peters Surgical |
| Jun 24, 2014 | ExacTrac is intended to be used to place patients at an accurately defined po... | When using multiple isocenters (radiation treatment targets) within a single plan, in certain wor... | Class II | Brainlab AG |
| Jun 10, 2014 | Tenor is a mobile passive lift, intended to be used on horizontal surfaces fo... | ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke durin... | Class II | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| May 21, 2014 | Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intrao... | Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intra... | Class II | Brainlab AG |
| May 9, 2014 | ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton ... | Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitor... | Class II | VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH |
| Apr 25, 2014 | RayStation software version 4.0.3.4 RayStation is a software system design... | This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT h... | Class II | RAYSEARCH LABORATORIES AB |
| Apr 15, 2014 | Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP... | The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is like... | Class I | Fisher & Paykel Healthcare, Ltd. |
| Mar 27, 2014 | Proteus 235 Proton Therapy System for cancer treatment. | While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low... | Class II | Ion Beam Applications S.A. |
| Mar 10, 2014 | SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installe... | The System may go into a controlled failed state if a series of parameters on the user interface ... | Class I | Del Mar Reynolds Medical, Ltd. |
| Mar 6, 2014 | API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (... | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... | Class II | BioMerieux SA |
| Mar 6, 2014 | FB Reagent (REF 70562). FB reagent is an additional test used for revealin... | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... | Class II | BioMerieux SA |
| Mar 6, 2014 | API Listeria (REF 10300). ZYM B reagent is used and included inside of API... | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... | Class II | BioMerieux SA |
| Mar 6, 2014 | ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to... | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... | Class II | BioMerieux SA |
| Mar 5, 2014 | Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. ... | The outer package label contained the incorrect length of the device. There is a label on the out... | Class II | Pega Medical Inc. |
| Feb 17, 2014 | TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkst... | If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the ... | Class III | Technidata S.A. |
| Feb 14, 2014 | RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alon... | RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software d... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 7, 2014 | Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid ... | The Male Components in this lot are made of material with lower strength than manufacturing speci... | Class II | Pega Medical Inc. |
| Feb 6, 2014 | RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 ... | Potential for dose errors due to software program errors. | Class II | RAYSEARCH LABORATORIES AB |
| Feb 6, 2014 | RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alo... | RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calcu... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 3, 2014 | Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured b... | Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. | Class II | Carl Zeiss Meditec AG |
| Dec 4, 2013 | Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, m... | Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculatio... | Class II | Ion Beam Applications S.A. |
| Nov 29, 2013 | steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in process... | Error copying information to the clinical file and to the report when two 3D models are opened si... | Class II | EOS Imaging |
| Nov 18, 2013 | Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative imag... | The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows ... | Class II | Brainlab AG |
| Nov 15, 2013 | BrainLAB's VectorVision spine is intended for use as an intraoperative image-... | Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with sp... | Class II | Brainlab AG |
| Oct 14, 2013 | VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measure... | Product is not approved or authorized for distribution in the US. | Class II | BioMerieux SA |
| Sep 27, 2013 | Breeze C Scooter is a motorized electric scooter for elderly people. Brand ... | Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it... | Class II | S.A.E. AFIKIM |
| Sep 24, 2013 | S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. ... | Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegi... | Class II | Sorin Group Deutschland GmbH |
| Sep 23, 2013 | Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, st... | The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sh... | Class I | Baylis Medical Corp * |
| Sep 18, 2013 | GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus... | GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires ... | Class II | GE Healthcare Beijing , Hangwei Medical Systems... |
| Sep 4, 2013 | Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calc... | Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens r... | Class II | SEPPIM SAS |
| Aug 9, 2013 | WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrumen... | The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia... | Class III | Copan Italia |
| Aug 5, 2013 | Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended ... | The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that... | Class II | Medicel Ag |
| Jul 25, 2013 | HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, He... | HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Mi... | Class II | HemoCue AB |
| Jul 16, 2013 | HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, ... | HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Al... | Class II | HemoCue AB |
| Jul 15, 2013 | HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. ... | During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack ... | Class II | HemoCue AB |
| Jul 3, 2013 | Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Pai... | Lancets were not sterilized within the dose range established by sterilization validation. | Class II | KooJoo Trading Company |
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.