Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-12-22FDA-DeviceSmith & Nephew, Inc.Class IIsmith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
- 2021-12-22FDA-DeviceSmith & Nephew, Inc.Class IIsmith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
- 2021-12-22FDA-DeviceMedline Industries IncClass IIBedside PICC CDS Convenience Kit
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
- 2021-12-22FDA-DeviceMedline Industries IncClass IIVenous Access Pack-LF Convenience Kit
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
- 2021-12-22FDA-DeviceMedline Industries IncClass IIMajor Vascular CDS Convenience Kit
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
- 2021-12-22FDA-DeviceMedline Industries IncClass IINeuro Convenience Kit
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
- 2021-12-22FDA-DeviceMedline Industries IncClass IIEVLP Convenience Pack/Kit
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
- 2021-12-22FDA-DeviceDatascope Corp.Class ICardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
- 2021-12-22FDA-DeviceDatascope Corp.Class ICardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45, 0998-UC-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65, 0998-UC-0800-65.
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
- 2021-12-15FDA-DevicePhilips North America LlcClass IIVeradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns
- 2021-12-15FDA-DevicePhilips North America LlcClass IIBV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns
- 2021-12-15FDA-DevicePhilips North America LlcClass IIBV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns
- 2021-12-15FDA-DeviceArgon Medical Devices, IncClass IISuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; 701118060/SUPERCORE BIOPSY INSTR 18GA X 6CM; 701118090/SUPERCORE BIOPSY INSTR 18GA X 9CM; 701118150/SUPERCORE BIOPSY INSTR 18GA X 15CM; 701118200/SUPERCORE BIOPSY INSTR 18GA X 20CM; 701120090/SUPERCORE BIOPSY INSTR 20GA X 9CM; 701120150/SUPERCORE BIOPSY INSTR 20GA X 15CM; 701120200/SUPERCORE BIOP
Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980X3JADIJJ
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980X3ENDIUU
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980X2ESDIEC
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980X1PLDIPC
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980X1JADIJJ
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980X1ENNISB
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980X1ENDIUU
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980X1ENDIPC
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator,980X1ENAIQC
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980U3ESDIUU
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980U1ESDIUC
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980U1ENASAA
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980S3ENDICU
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980S1ENDICU
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980A3ENNISB
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceCovidien LlcClass IPuritan Bennett 980 Series Ventilator, 980A1ENNISB
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- 2021-12-15FDA-DeviceOsteomed, LLCClass IIOsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II R
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
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