Browse Device Recalls
2,115 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,115 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 2,115 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 2, 2017 | Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysi... | The diagnostic test kit may produce invalid test runs which may delay test results. | Class II | Epigenomics Ag |
| Oct 30, 2017 | CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the... | Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after... | Class II | Sorin Group Deutschland GmbH |
| Oct 28, 2017 | fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows aud... | Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat... | Class II | NordicNeuroLab AS |
| Oct 19, 2017 | Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy ... | Range for the same energy could be different depending if the layer is the first layer of the ir... | Class II | Ion Beam Applications S.A. |
| Oct 18, 2017 | NucliSENS Lysis Buffer Extended lot for RES 76675 | Elute may become colored due to the residual presence of heme group origination from hemoglobin p... | Class II | BioMerieux SA |
| Oct 17, 2017 | Proteus 235, graphite block 8 | IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader | Class II | Ion Beam Applications S.A. |
| Oct 17, 2017 | Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 ma... | Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. | Class II | Southmedic, Inc. |
| Oct 16, 2017 | Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: ... | For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices... | Class II | Fukuda Denshi Co., Ltd. |
| Oct 16, 2017 | Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remi... | Beckman Coulter has identified that due to a software nonconformity in connection with a changed ... | Class II | Normand Informatique |
| Oct 11, 2017 | Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and ... | Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical venti... | Class I | Spacelabs Healthcare, Ltd. |
| Oct 3, 2017 | Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Num... | Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue ... | Class III | Degania Silicone, Ltd. |
| Sep 25, 2017 | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the ... | The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information r... | Class III | PerkinElmer Life and Analytical Sciences, Walla... |
| Sep 22, 2017 | Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO | Leaks complaints. | Class II | Guangzhou Improve Medical Instruments Co., Ltd. |
| Sep 22, 2017 | Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Pr... | Complain due to the hub needle came out when the nurse draw the blood and removed the tube. | Class II | Guangzhou Improve Medical Instruments Co., Ltd. |
| Sep 12, 2017 | OTTO BOCK Kenevo knee joints Model 3C60 | Otto Bock Healthcare Products GmbH has identified a design issue through extended durability tes... | Class II | Otto Bock Healthcare Product |
| Sep 12, 2017 | OTTO BOCK Kenevo knee joints Model 3C60=ST | Otto Bock Healthcare Products GmbH has identified a design issue through extended durability tes... | Class II | Otto Bock Healthcare Product |
| Sep 8, 2017 | Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during i... | An internal analysis on complaints received indicated that the welding process may have been perf... | Class II | Limacorporate S.p.A |
| Sep 1, 2017 | Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS I... | There is a potential failure of the top plate assembly, which is the component that connects the ... | Class II | Permobil, Ab |
| Sep 1, 2017 | Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500 | There is a potential failure of the top plate assembly, which is the component that connects the ... | Class II | Permobil, Ab |
| Aug 30, 2017 | Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the... | The device had an incorrect printed calibration value on the calibration certificate. | Class II | Carl Zeiss Meditec AG |
| Aug 23, 2017 | Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034... | The high control for the kit is recovering low and may be out of range for assigned values. | Class II | The Binding Site Group, Ltd. |
| Aug 10, 2017 | Oncentra Brachy 4.5 radiation therapy software The firm name on the label is... | Incorrect source step size may occur in the software plans | Class II | Nucletron BV |
| Aug 8, 2017 | Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. ... | Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecti... | Class I | Leonhard Lang Medizintechnik GmbH |
| Jul 28, 2017 | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is... | Risk of unintended motion while the AIRO system is in transport mode. | Class II | Brainlab AG |
| Jul 24, 2017 | Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implan... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral ... | There is a possibility that the protective foam insert used during the packaging of the affected ... | Class II | ZIMMER ORTHOPEDIC MFG LTD |
| Jul 24, 2017 | Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implant... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implanta... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implant... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillator... | Class II | Sorin Group Italia SRL - CRF |
| Jul 17, 2017 | RayStation Product Usage: is a software system designed for treatment pl... | For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout positi... | Class II | RAYSEARCH LABORATORIES AB |
| Jul 13, 2017 | Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumin... | Stylette removal difficulties on the Euphora and Solarice products. | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Jul 13, 2017 | THERMI250 Radiofrequency System. Intended to provide heating for the purpo... | In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. | Class II | Bios S.r.l. |
| Jul 13, 2017 | Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumi... | Stylette removal difficulties on the Euphora and Solarice products. | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Jul 13, 2017 | Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W2... | The firm received several customer complaints reporting some perioperative breakages of NE0411 No... | Class II | In2Bones, SAS |
| Jul 13, 2017 | BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is pa... | Potential for intermittent lighting (flickering) during use. | Class II | Bomimed |
| Jul 5, 2017 | Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold indiv... | The power drill torque limiter may break during use in surgery application. | Class II | Orthofix Srl |
| Jul 4, 2017 | JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is int... | Three (3) complaints were identified in which the potential for utilization of the JTS Grower Dr... | Class II | Stanmore Implants Worldwide Ltd. |
| Jul 3, 2017 | Beijing Syntech Laser Trixel C02 Laser surgical lasers | The noncompliance is that the certification label was not affixed on the product, with statement... | Class II | Beijing Syntech Laser Co., Ltd |
| Jul 3, 2017 | Beijing Syntech Laser Nice Station Light Based Platform surgical lasers | The noncompliance is that the certification label was not affixed on the product, with statement... | Class II | Beijing Syntech Laser Co., Ltd |
| Jul 3, 2017 | Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers | The noncompliance is that the certification label was not affixed on the product, with statement... | Class II | Beijing Syntech Laser Co., Ltd |
| Jul 3, 2017 | Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers | The noncompliance is that the certification label was not affixed on the product, with statement... | Class II | Beijing Syntech Laser Co., Ltd |
| Jul 3, 2017 | Beijing Syntech Laser UL Station surgical lasers | The noncompliance is that the certification label was not affixed on the product, with statement... | Class II | Beijing Syntech Laser Co., Ltd |
| Jul 3, 2017 | Beijing Syntech Laser Diode Laser surgical lasers | The noncompliance is that the certification label was not affixed on the product, with statement... | Class II | Beijing Syntech Laser Co., Ltd |
| Jul 3, 2017 | Beijing Syntech Laser UL C02 Laser surgical lasers | The noncompliance is that the certification label was not affixed on the product, with statement... | Class II | Beijing Syntech Laser Co., Ltd |
| Jul 3, 2017 | Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers | The noncompliance is that the certification label was not affixed on the product, with statement... | Class II | Beijing Syntech Laser Co., Ltd |
| Jun 27, 2017 | NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH... | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach... | Class II | NOVADAQ TECHNOLOGIES INC. |
| Jun 27, 2017 | NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH... | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach... | Class II | NOVADAQ TECHNOLOGIES INC. |
| Jun 27, 2017 | NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape... | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach... | Class II | NOVADAQ TECHNOLOGIES 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.