Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-10-02FDA-DeviceGN OtometricsClass IIGold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Sna
The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
- 2019-10-02FDA-DeviceSentinel CH SpAClass IIAlinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results
- 2019-10-02FDA-DeviceSentinel CH SpAClass IIMULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results
- 2019-10-02FDA-DevicePhilips North America LLCClass IIPhilips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore not be effective on an adult.
- 2019-10-02FDA-DeviceMusculoskeletal Transplant Foundation, Inc.Class IIQuickGraft¿ Model # 430PST
Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.
- 2019-10-02FDA-DevicePhilips HealthcareClass IIDigitalDiagnost C50, Stationary X-ray System
During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the issue is, and relevant affected product, the actions you are required to take and the actions planned by Philips to correct the issue. If you need any or further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377.
- 2019-10-02FDA-DeviceB. Braun Medical, Inc.Class IB.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
- 2019-10-02FDA-DeviceGE Healthcare, LLCClass IIProteus XR/a (SlOK : K993090)
Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
- 2019-09-25FDA-DevicePhilips North America, LLCClass IIIntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue MX40 Patient Worn Monitors in the USA, to extend the coverage area of a Core Access Point for the wireless Smart-hopping system.
Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations
- 2019-09-25FDA-DeviceCooperSurgical, Inc.Class IIILEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day were reversed.
- 2019-09-25FDA-DeviceAd-Tech Medical Instrument CorporationClass IIAD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
- 2019-09-25FDA-DeviceBoston Scientific CorporationClass IISubcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
- 2019-09-25FDA-DeviceBoston Scientific CorporationClass IISubcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
- 2019-09-25FDA-DeviceWilson-Cook Medical Inc.Class IIHemospray Endoscopic Hemostat
Potential for Hemospray device to be unable to spray powder due to misassembly of devices.
- 2019-09-25FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.
- 2019-09-18FDA-DeviceStryker CommunicationsClass IIBerchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.
The back cover of the light head was insufficiently assembled and could potentially fall off the light.
- 2019-09-18FDA-DeviceStryker CommunicationsClass IIBerchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.
The back cover of the light head was insufficiently assembled and could potentially fall off the light.
- 2019-09-18FDA-DeviceSmith & Nephew, Inc.Class IILEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.
The affected products were inadvertently packaged with an incorrect screw component.
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIVanguard XP Tibial Tray 87 mm Item # 195254
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIVanguard XP Tibial Tray 83 mm Item # 195253
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIVanguard XP Tibial Tray 79 mm Item # 195252
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIVanguard XP Tibial Tray 75 mm Item # 195251
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIVanguard XP Tibial Tray 73 mm Item # 195250
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIVanguard XP Tibial Tray 71 mm Item # 195249
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIVanguard XP Tibial Tray 69 mm Item # 195248
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIVanguard XP Tibial Tray 67 mm Item # 195247
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIVanguard XP Tibial Tray 65 mm Item # 195246
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIVanguard XP Tibial Tray 63 mm Item # 195245
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-XP Tibial Tray - Interlok 59 mm Item # 195750
The locking bar not fully engaging
- 2019-09-18FDA-DeviceZimmer Biomet, Inc.Class IIXP-XP Tibial Tray - Interlok 63 mm Item # 195751
The locking bar not fully engaging
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