BEUDAMED
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    Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·October 15, 2021

    Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·October 15, 2021

    FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

    FDA Recall
    Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·September 3, 2025

    FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

    FDA Recall
    Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·September 3, 2025

    Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JGS·November 18, 2021

    Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·December 2, 2016

    Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below capillary closure during the alternation cycle.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Synergy Pulse, Powered Flotation Therapy bed, Model number 5609. Designed to provide enhanced static and pulsation pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing pulsation therapy.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607. Designed to provide enhanced static, pulsation and rotational pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing alternating pressure therapy and lateral rotation up to 45 degrees side to side.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271540 FLEXIMA BILIARY FIRM 8F/35CM M001271550 FLEXIMA BILIARY FIRM 10F/35CM M001271560 FLEXIMA BILIARY REG 8F/35CM M001271570 FLEXIMA BILIARY REG 10F/35CM M001271580 FLEXIMA BILIARY REG 12F/35CM M001271590 FLEXIMA BILIARY REG 14F/35CM M001271600 FLEXIMA BILIARY SOFT 10F/35CM M001271610 FLEXIMA BILIARY SOFT 12F/35CM M001271620 FLEXIMA BILIARY SOFT 14F/35CM M001281560 FLEXIMA BILIARY 8/35 TT M001281570 FLEXIMA BILIARY 10/35 TT M001281580 FLEXIMA BILIARY 12/35 TT M001281590 FLEXIMA BILIARY 14/35 TT M001271630 FLEXIMA BIL 8F/35CM FIRM KIT M001271640 FLEXIMA BIL 10F/35CM FIRM KIT M001271650 FLEXIMA BIL 8F/35CM REG KIT M001271660 FLEXIMA BIL 10F/35CM REG KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFA·March 18, 2009

    Hill-Rom brand Resident LT bed ambulatory assist bar accessory; accessory P865A.

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code KMM·November 14, 2003

    SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Recall
    Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

    SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Recall
    Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

    SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Recall
    Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

    SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Recall
    Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

    SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Recall
    Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

    SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Recall
    Open, Classified ·Cordis Corporation·Product code FGE·October 1, 2021

    Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code HDD·September 6, 2007

    FLEXICAIR MC3 Low Airloss Therapy unit

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·August 27, 2003