Category Archives: Medical Device Recalls

Date: 09/04/2022

Product Names: Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
Distribution Dates: January 6, 2022, to January 20, 2022
Devices Recalled in the U.S.: 51,240
Date Initiated by Firm: April 9, 2022

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/woodside-acquisitions-inc-recalls-oral-rapid-sars-cov-2-antigen-rapid-test-kits-and-joysbio-sars-cov

Date: 08/04/2022

Product Name: ArjoHuntleigh Polska Sara Plus floor lift
Product Serial Numbers: See recall database entry
Manufactured Dates: October 13, 2016, to January 13, 2022; Other units that received spare parts (printed circuit board) through March 4, 2022
Devices Recalled in the U.S.: 1,929 (includes affected spare parts)
Date Initiated by Firm: April 8, 2022

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/arjohuntleigh-polska-recalls-sara-plus-floor-lift-risk-smoke-or-fire-when-lift-used-depleted-battery

Date: 06/04/2022

Product Name: Accula SARS-CoV-2 Test
Product Codes: QJR
Lot Numbers: See recall database entry
Manufactured Dates: December 30, 2021 to January 1, 2022; January 15, 2022 to January 23, 2022
Distribution Dates: January 19, 2022 to February 8, 2022
Devices Recalled in the U.S.: 6,177
Date Initiated by Firm: April 6, 2022

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/mesa-biotech-inc-recalls-certain-accula-sars-cov-2-tests-risk-false-positives-caused-contamination

Date: 21/03/2022

Product Name: Avanos Medical Cortrak*2 Enteral Access System
Product Codes and Serial Numbers: See recall database entry
Distribution Dates: April 1, 2016 to January 1, 2022
Devices Recalled in the U.S.: 629
Date Initiated by Firm: March 21, 2022

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause

Date: 04/03/2022

Product Names: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold), may also be called Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit, Lateral Flow COVID 19 Rapid Antigen Test, SKIPPACK COVID-19 Antigen Home Test
Product Codes: See Recall Database Entry
Distribution Dates: January 21, 2022 to February 11, 2022
Devices Recalled in the U.S.: Up to 209,450
Date Initiated by Firm: March 4, 2022

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/sml-distribution-llc-recalls-skippack-medical-lab-covid-19-direct-antigen-rapid-tests-are-not

Date: 28/02/2022

Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test
Product Code: 83QKP
Lot Numbers: See Recall Database Entry
Distribution Dates: June 2, 2021, to December 21, 2021
Devices Recalled in the U.S.: 45,500
Date Initiated by Firm: February 28, 2022

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/celltrion-usa-recalls-certain-point-care-celltrion-diatrust-covid-19-ag-rapid-tests-false-positive

Date: 04/02/2022

Product Names: TurboHawk Plus Directional Atherectomy System
Product Codes:
See Recall Database Entry (Small vessel)
See Recall Database Entry (Multi vessel)
Manufacturing Dates: July 21, 2021 to November 25, 2021
Distribution Dates: September 27, 2021 to January 25, 2022
Devices Recalled in the U.S.: 686
Date Initiated by Firm: February 4, 2022

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-turbohawk-plus-directional-atherectomy-system-due-risk-tip-damage-during-use

Date: 31/01/2022

Product Name: SD Biosensor STANDARD Q COVID-19 Ag Home Test
Product Codes and Lot Numbers: See recall database entry
Distribution Dates: August 26, 2021 to January 30, 2022
Devices Recalled in the U.S.: Up to 397,700 units
Date Initiated by Firm: January 31, 2022

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/sd-biosensor-recalls-standard-q-covid-19-ag-home-tests-are-not-authorized-cleared-or-approved-fda

Date: 27/01/2022

Product Names: E25Bio COVID-19 Direct Antigen Rapid Test; Trade Name: E25Bio SARS-CoV-2 Antigen Test Kit
Product Codes and Model Numbers: See Recall Database Entry
Distribution Dates: September 2020 to November 2021
Devices Recalled in the U.S.: 73,300
Date Initiated by Firm: January 27, 2022

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/e25bio-recalls-covid-19-direct-antigen-rapid-tests-are-not-authorized-cleared-or-approved-fda-and

Date: 24/01/2022

Product Name: Philips Respironics V60 and V60 Plus Ventilator
Product Codes and Serial Numbers: See recall database entries:
V60 Ventilator
V60 Plus Ventilator
Distribution Dates: July 29, 2021 to August 11, 2021
Devices Recalled in the U.S.: 1,511
Date Initiated by Firm: January 24, 2022

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-v60-and-v60-plus-ventilators-expired-adhesive-may-cause