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 2, 2014 | EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Us... | The device labeling is stamped with 330cc and the device is actually 380cc device. | Class II | Mentor Texas, LP. |
| Jul 2, 2014 | ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiologic... | The transmitter display and the Telemetry Central Station display may show a SpO2 value when the ... | Class II | Spacelabs Healthcare 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 | CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynare... | "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if... | Class II | Dynarex Corporation |
| Jul 2, 2014 | TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERIL... | There was an error in manufacturing which resulted in the proximal lag screw hole being positione... | Class II | Smith & Nephew, Inc. |
| Jul 2, 2014 | DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in provi... | Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tu... | Class II | AGFA Healthcare Corp. |
| Jul 2, 2014 | Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DE... | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned re... | Class III | Carestream Health Inc. |
| Jul 2, 2014 | INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL... | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned re... | Class III | Carestream Health 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 1, 2014 | Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRU... | The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument ma... | Class II | Biomet, Inc. |
| Jul 1, 2014 | Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. ... | The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP ... | Class II | Ansar Group, Inc. Dba Ansar Medical Technologie... |
| Jul 1, 2014 | InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagno... | Product was distributed without 510(k) approval. | Class II | Biogenex Laboratories, Inc. |
| Jul 1, 2014 | Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 2... | Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenest... | Class II | Zimmer, Inc. |
| Jul 1, 2014 | Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument ... | Risk of incorrect results from samples prepared with Panthera-Puncher 9 | Class II | PerkinElmer Health Sciences, Inc. |
| Jul 1, 2014 | PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non... | The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the... | Class II | Zimmer, Inc. |
| Jul 1, 2014 | PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non... | The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the... | Class II | Zimmer, Inc. |
| Jun 30, 2014 | Philips IP5 Information Portal The Expression Information Portal (Model IP... | The wireless function of the IP5 radio could be interrupted causing loss of wireless communicatio... | Class II | Invivo Corporation |
| Jun 30, 2014 | Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set | A screw set was returned from the field for destruction after being exposed to flood water, which... | Class II | Synthes, Inc. |
| Jun 30, 2014 | PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment ... | RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility th... | Class II | Ra Medical Systems Inc |
| Jun 30, 2014 | RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, N... | There is a possibility the handle of the laryngoscope may heat up and melt the end cap. | Class II | Teleflex Medical |
| Jun 30, 2014 | Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: ... | STERIS has identified that deformation of the washers door handle pin may occur when the door ha... | Class III | Steris Corporation |
| Jun 30, 2014 | Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Pi... | Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A ... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 27, 2014 | The STERIS 4085 General Surgical Table Product Usage: is an electro-hydra... | STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifol... | Class II | Steris Corporation |
| Jun 27, 2014 | Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray ... | Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility t... | Class II | Integra LifeSciences Corp. |
| Jun 27, 2014 | Life Force Chamber Product Usage:The product is intended for restful cont... | The Life Force chamber is marketed and promoted as a medical device, intended for use in the diag... | Class II | Life Force of Tampa, LLC |
| Jun 27, 2014 | PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Pro... | Potential for demographic information and test result to be mismatch. | Class II | PerkinElmer Health Sciences, Inc. |
| Jun 27, 2014 | Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Vi... | The following defects have been identified for data loaded with Patient Data Manager version 2.0 ... | Class II | Brainlab AG |
| Jun 26, 2014 | Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the S... | Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that ... | Class II | Alphatec Spine, Inc. |
| Jun 26, 2014 | Esaote PA230E Transducer A portable and cart base ultrasound system for gene... | Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D... | Class II | Biosound Esaote, Inc. |
| Jun 26, 2014 | Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be us... | The attachment latch mechanism can become bent depending on user handling. Latch mechanism bendi... | Class II | Hill-Rom, Inc. |
| Jun 25, 2014 | Merci Retriever Intended to restore blood flow in the neurovasculature by ... | Merci Retrievers were shipped to US customers past their expiration date, even though they were l... | Class II | Concentric Medical Inc |
| Jun 25, 2014 | MediChoice Dual-Release Folding Walker with 5" wheel | Product wheels may be too loose, too tight, or fall off. | Class II | Owens & Minor Distribution, Inc. |
| Jun 25, 2014 | Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentrat... | The case label correctly states partial rebreather but the insert label incorrectly states non-re... | Class II | Salter Labs |
| Jun 25, 2014 | Essential NEO, Audio/Visual Integration Unit An audio/visual integration u... | KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable cou... | Class II | Karl Storz Endoscopy |
| Jun 25, 2014 | McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for comple... | McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to es... | Class II | Mckesson Information Solutions LLC |
| Jun 25, 2014 | Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006 | Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant,... | Class II | Zimmer, Inc. |
| 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 25, 2014 | BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abut... | Identifiers on the label are correct but the label has the incorrect color coding. | Class II | Biomet 3i, LLC |
| Jun 25, 2014 | Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquat... | The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result... | Class II | Invacare Corporation |
| 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 24, 2014 | Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Med... | The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jun 24, 2014 | Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits... | Potential for inadvertent scalpel stick injury involving the safety scalpel. | Class II | Bard Access Systems |
| Jun 24, 2014 | MK5 NX Controller--Wheelchair controller | M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were ... | Class II | Invacare Corporation |
| Jun 23, 2014 | Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000... | Product was held at temperature above the labeled recommended storage temperature | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 23, 2014 | SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test ... | Complaints of failed calibration. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jun 23, 2014 | Cordis EMPIRA RX PTCA Dilatation Catheter | The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected... | Class II | Cordis Corporation |
| Jun 23, 2014 | Device Brand Name: Distal Radius Fracture Repair System Device Classificatio... | The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill ... | Class II | Biomet, Inc. |
| Jun 23, 2014 | SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test ... | Complaints of failed calibration. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jun 23, 2014 | BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat... | Flat Panel Display (FPD) failed to remain securely locked in the deployed position. | Class II | Philips Medical Systems (Cleveland) 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.