BEUDAMED
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    Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012

    FDA Recall
    Open, Classified ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code FDS·July 27, 2023

    Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·July 17, 2024

    Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·July 17, 2024

    Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional.

    FDA Recall
    Open, Classified ·Zyno Medical LLC·Product code FRN·September 30, 2024

    BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·May 21, 2024

    HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).

    FDA Recall
    Open, Classified ·Covidien LLC·Product code MWI·January 30, 2026

    GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

    FDA Recall
    Open, Classified ·GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany·Product code LLZ·November 3, 2025

    Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·January 24, 2023

    Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code DQX·December 12, 2019

    Lugol s Iodine Solution 500ML, Part Number 624-71

    FDA Recall
    Open, Classified ·EMD Millipore Corporation·Product code IAM·October 17, 2023

    Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.

    FDA Recall
    Open, Classified ·EMD Millipore Corporation·Product code HZT·January 26, 2024

    Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

    FDA Recall
    Open, Classified ·Young Dental Manufacturing I, LLC·Product code EJR·May 13, 2024

    SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MOS·June 5, 2024

    SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MOS·June 5, 2024

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MOS·June 5, 2024

    Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension clinical chemistry system SMN: 10700795 (DF207)

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code MLM·January 30, 2023

    CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSEMBLY; (3) Part #2082293-002, FRU MP200 CPU ASSEMBLY; (4) Part #2071523-001, MP200 22 IN DISPLAY WITH TOUCH; (5) Part #2092930-001, DSP LCD 22 IN MED W/TCH W/DKST N AMR; (6) Part #2092930-002, DSP LCD 22 IN MED W/TCH W/DKST BRIT P/C; (7) Part #2092930-003, DSP LCD 22IN MED W/TCH W/DKST EURO P/C; (8) Part #2092930-004, DSP LCD 22IN MED W/TCH W/DKST ITA P/C; (9), Part #2092930-005, DSP LCD 22IN MED W/TCH W/DKST INDIAN P/C; (10) Part #2092930-006, DSP LCD 22IN MED W/TCH W/DKST ISREAL P/C; (11) Part #2092930-007, DSP LCD 22IN MED W/TCH W/DKST SWISS P/C; (12) Part #2092930-008, DSP LCD 22IN MED W/TCH W/DKST AUSTRL P/C; (13) Part #2092930-009, DSP LCD 22IN MED W/TCH W/DKST JPN; (14) Part #2092930-010, DSP LCD 22IN MED W/TCH W/DKST BRZL P/C; (15) Part #2092930-011, DSP LCD 22IN MED W/TCH W DKST ARGNT P C; (16) Part #2092930-012, DSP LCD 22IN MED W TCH W DKST DENMARK; (17) Part #2092930-013, DSP LCD22IN MED W TCH W DKST S AFRICA P C; and (18) Part #2092930-014, DSP LCD22IN MED W TCH W DKST CHINA P C.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code DXJ·May 10, 2022