Medical DeviceAug 31, 2022
GE Healthcare (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX recall — FDA Z-1566-2022
Inaccurate Distance and Area measurements with use of Global Stack viewport.
Class IIFDA: OngoingGE Healthcare, LLC
August 2022 recalls — page 3
These records include useful source details for the selected month.
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office B. BRAUN MEDICAL INC. Anesthesia Support recall — FDA Z-1616-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office a. MMS - IMMUNOSTICS INC McKesson Rapid Test recall — FDA Z-1601-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office Drugs of Abuse Tests: a recall — FDA Z-1589-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office GETINGE USA SALES LLC OCEAN Chest Drain recall — FDA Z-1607-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office BEAVER-VISITEC INTERNATIONAL, INC recall — FDA Z-1625-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124 recall — FDA Z-1562-2022
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceAug 31, 2022
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF recall — FDA Z-1576-2022
There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP recall — FDA Z-1585-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office STERIS CORP Revital-Ox Resert Hydrogen recall — FDA Z-1605-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office MEDICAL CHEMICAL CORPORATION Total-Fix STOOL recall — FDA Z-1637-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit recall — FDA Z-1599-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office a. Medefil Normal Saline IV Flush Syringe recall — FDA Z-1619-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Wright Medical Technology Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets recall — FDA Z-1567-2022
An incorrect sizing label was applied to the carton packaging.
Class IIFDA: OngoingWright Medical Technology, Inc.
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office a. METREX RESEARCH CORP CaviCide1 recall — FDA Z-1620-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025 recall — FDA Z-1579-2022
There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office MAGELLAN DIAGNOSTICS LeadCare II Blood Lead recall — FDA Z-1597-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office BECKMAN COULTER, INC. a recall — FDA Z-1629-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office CENTURION MEDICAL PRODUCTS, LP Centurion recall — FDA Z-1630-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office Excelsior Heparin Sodium, Porcine recall — FDA Z-1596-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm recall — FDA Z-1565-2022
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Class IIFDA: OngoingNobel Biocare
Medical DeviceAug 31, 2022
Baxter Healthcare The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare recall — FDA Z-1570-2022
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceAug 31, 2022
Mckesson Medical-Surgical Inc. Corporate Office Perifix LOR Syringe Perifix 8 mL Pouch Luer recall — FDA Z-1591-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between…
Class IIFDA: OngoingMckesson Medical-Surgical Inc. Corporate Office
Medical DeviceAug 31, 2022
Getinge Usa Sales Servo-air Ventilator System-The Servo-air Ventilator System is: Intended recall — FDA Z-1568-2022
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the…
Class IIFDA: OngoingGetinge Usa Sales Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.