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 |
|---|---|---|---|---|
| Feb 17, 2014 | XiO RPT System The XiO RTP System is used to create treatment plans for an... | Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used wit... | Class II | Elekta, Inc. |
| Feb 17, 2014 | Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton... | WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due t... | Class II | WalkMed Infusion, LLC |
| 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 | Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Produc... | Philips HeartStart XL may experience a power board failure causing failure to defibrillate | Class II | Philips Medical Systems, Inc. |
| Feb 14, 2014 | GE Healthcare Optima CT580/Discovery CT590RT scanners running software versio... | GE Healthcare has recently become aware of a potential safety issue due to a software issue assoc... | Class II | GE Healthcare, LLC |
| Feb 14, 2014 | Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Re... | Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed ... | Class II | Spacelabs Healthcare, Llc |
| 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 14, 2014 | ROSA Surgical Device 2.5.8. It is intended to be used in the operating ro... | An undetected shift between the information displayed in the navigation software and the actual p... | Class II | Zimmer Biomet, Inc. |
| Feb 14, 2014 | Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A ... | HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) ... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Feb 13, 2014 | GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.... | GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patien... | Class II | GE Healthcare, LLC |
| Feb 13, 2014 | VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011... | Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an... | Class II | Accumetrics Inc |
| Feb 13, 2014 | MULTIX FUSION. The Multix Fusion system is a radiographic system used in h... | It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system bec... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 12, 2014 | On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indi... | Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 ... | Class II | CryoLife, Inc. |
| Feb 12, 2014 | ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (... | Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential... | Class II | Abbott Laboratories |
| Feb 12, 2014 | ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibra... | Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential... | Class II | Abbott Laboratories |
| Feb 12, 2014 | CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog ... | Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2... | Class II | Biosense Webster, Inc. |
| Feb 11, 2014 | AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nit... | Marketing the devices outside 510(k) requirements | Class II | AMS Diagnostics, LLC |
| Feb 11, 2014 | AMS AST For the In vitro quantitative determination of AST in serum Quant... | Marketing the devices outside 510(k) requirements | Class II | AMS Diagnostics, LLC |
| Feb 11, 2014 | Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. | Philips Medical Systems have recently determined that a software nonconformance can cause incorre... | Class II | Philips Medical Systems (Cleveland), Inc. |
| Feb 11, 2014 | Trilogy Ventilators The Respironics Trilogy 100 system provides continuous o... | Internal testing revealed a potentially defective component on the power management board that co... | Class I | Phillips Respironics, Inc. |
| Feb 11, 2014 | AMS URIC ACID For the In vitro quantitative determination of Uric Acid in ser... | Marketing the devices outside 510(k) requirements | Class II | AMS Diagnostics, LLC |
| Feb 11, 2014 | The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Us... | The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 ins... | Class II | Synthes, Inc. |
| Feb 10, 2014 | bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medic... | The firm has determined the product may fail to dispense the sample to the agar plate resulting i... | Class II | Biomerieux Inc |
| Feb 10, 2014 | BencoDental tartar & stain remover ultrasonic cleaning solution Product Us... | As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is r... | Class II | Heraeus Kulzer, LLC. |
| Feb 10, 2014 | The Thermedx Fluid Management System is designed to provide irrigation fluids... | A vendor changed the manufacturing process of a component used in the canister ring that may affe... | Class II | Thermedx LLC |
| Feb 7, 2014 | GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Du... | Potential safety issue related to unintended radial detector motion, which may occur during patie... | Class II | GE Healthcare, LLC |
| Feb 7, 2014 | Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Pr... | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... | Class II | Convatec Inc. |
| Feb 7, 2014 | Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care... | The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Crit... | Class I | Draeger Medical Systems, Inc. |
| Feb 7, 2014 | Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD1191... | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... | Class II | Convatec Inc. |
| Feb 7, 2014 | SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product U... | Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volum... | Class I | Baxter Healthcare Corp. |
| Feb 7, 2014 | HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis... | In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional inform... | Class II | Leica Biosystems Imaging, Inc. |
| Feb 7, 2014 | SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Us... | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... | Class II | Convatec Inc. |
| Feb 7, 2014 | 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: L... | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... | Class II | Convatec Inc. |
| Feb 7, 2014 | MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: ... | Tyvek packaging may be worn, causing loss of package integrity. | Class II | Biocardia, Inc. |
| Feb 7, 2014 | GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended u... | Potential safety issue related to unintended radial detector motion, which may occur during patie... | Class II | GE Healthcare, LLC |
| Feb 7, 2014 | AXIOM Artis Systems Product usage: Artis zee is a family of dedicated ang... | Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriat... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 7, 2014 | SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Late... | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... | Class II | Convatec Inc. |
| 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 7, 2014 | Artis Zee Angiographic x-ray systems. | An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 7, 2014 | JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Fol... | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... | Class II | Convatec Inc. |
| Feb 7, 2014 | FMP X-alt Acetabular Liner This acetabular liner is intended for use with ... | Packaging error -- two different types and sizes of acetabular liners used during hip replacement... | Class II | Djo Surgical |
| Feb 7, 2014 | Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera... | Potential safety issue related to unintended radial detector motion, which may occur during patie... | Class II | GE Healthcare, LLC |
| Feb 6, 2014 | Philips HeartStart Home and OnSite (HS1) automated external defibrillators (A... | Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) be... | Class II | Philips Medical Systems North America 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 | Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2... | Incorrect master label. | Class III | Medtronic Vascular |
| Feb 6, 2014 | Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is ... | Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Contr... | Class II | Lin-Zhi International Inc |
| 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 6, 2014 | Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 ... | Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed C... | Class II | Philips Medical Systems North America Inc. |
| Feb 6, 2014 | Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is ... | Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Cont... | Class II | Lin-Zhi International Inc |
| Feb 5, 2014 | Synthes 5.0mm Variable Locking Screw This device is part of the Variable A... | Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 ... | Class II | Synthes, 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.