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.
- 2020-04-15FDA-DeviceJames Leckey Design LtdClass IIFirefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.
The firm received reports of a number of broken latches on the floorsitter.
- 2020-04-15FDA-DeviceCHANGE HEALTHCARE CANADA COMPANYClass IIMcKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format
- 2020-04-15FDA-DeviceSolta Medical IncClass IIThermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.
- 2020-04-15FDA-DeviceSiemens Medical Solutions USA, IncClass IIPRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
- 2020-04-15FDA-DeviceSiemens Medical Solutions USA, IncClass IIONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
- 2020-04-15FDA-DeviceSiemens Medical Solutions USA, IncClass IIMEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
- 2020-04-15FDA-DeviceSiemens Medical Solutions USA, IncClass IIARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
- 2020-04-15FDA-DeviceSynvasive Technology IncClass IIZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
- 2020-04-15FDA-DeviceAAP Implantate AgClass IIaap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.
- 2020-04-15FDA-DeviceBeckman Coulter Inc.Class IIBeckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results.
- 2020-04-15FDA-DeviceBeckman Coulter Inc.Class IILabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.
A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that Data Management System computers would not restart. If the computer is unable to restart, then the system cannot download data generated from MicroScan instruments or manually entered microbiology test results, resulting in a potential of delayed results.
- 2020-04-15FDA-DeviceQualigen IncClass IIThe FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32
The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.
- 2020-04-15FDA-DeviceAbbott Laboratories, IncClass IIARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the sample with the reagent inside of the cuvettes.
Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- 2020-04-15FDA-DeviceBiomet, Inc.Class IIBIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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