16 results · 20ms · Sources: EU EUDAMED, US FDA

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FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

FDA Recall
Open, Classified ·BioFire Diagnostics, LLC·Product code QBH·December 14, 2023

FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

FDA Recall
Open, Classified ·BioFire Diagnostics, LLC·Product code QDS·December 14, 2023

The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

FDA Recall
Open, Classified ·Vision RT Ltd Dove House Arcadia Avenue London United Kingdom·Product code IWE·August 27, 2025

Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PCH-LF, Model Number: DYNJ81281; 5) NHS - C-SECTION SCG, Model Number: DYNJ40573A; 6) C-SECTION CDS, Model Number: CDS983998C; 7) C-SECTION ADD ON PACK, Model Number: DYNJ64300A; 8) EMERGENCY BIRTH PACK, Model Number: DYNJ55205; 9) C-SECTION PACK, Model Number: DYNJ56550; 10) C-SECTION ADD ON PACK, Model Number: DYNJ83507; 11) C-SECTION CLOSURE PACK, Model Number: DYNJ83248; 12) C-SECTION PCH-LF, Model Number: DYNJ81281

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OHM·March 3, 2025

Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack Number DYNDA2519; 4) ED PREP TRAY, Pack Number DYNDA2519H ; 5) PRE-OP PREP KIT , Pack Number DYNDA3076; 6) PILGRIM PREP TRAY , Pack Number DYNDC3282; 7) PILGRIM PREP TRAY , Pack Number DYNDC3282A ; 8) PILGRIM PREP TRAY , Pack Number DYNDC3282B ; 9) KYPHO PREP PACK-LF, Pack Number DYNJ0618280G ; 10) KYPHO PREP PACK-LF, Pack Number DYNJ0618280I ; 11) KYPHO PREP PACK-LF, Pack Number DYNJ0618280J ; 12) SPECIAL PROCEDURE PREP TRAY-LF, Pack Number DYNJ0738967A ; 13) BASIC SET UP PACK-LF, Pack Number DYNJ28988I ; 14) BASIC SET UP PACK-LF , Pack Number DYNJ28988I ; 15) VERTEBRALPLASTY PREP TRAY PACK, Pack Number DYNJ36311A ; 16) PK-SETUP PACK , Pack Number DYNJ43804A ; 17) SKIN LESION PACK, Pack Number DYNJ44258G ; 18) SETUP PACK, Pack Number DYNJ46187D ; 19) PK-SET UP -LF , Pack Number DYNJ53220B ; 20) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857A ; 21) SKIN SCRUB PACK , Pack Number DYNJ68561; 22) DMEK PREP PACK, Pack Number DYNJ81659A ; 23) SET UP PACK , Pack Number DYNJ84247; 24) BASIC SET UP PACK-LF, Pack Number DYNJ85036; 25) SET UP CDS-ASC, Pack Number DYNJ900073C; 26) GENERAL SET UP, Pack Number DYNJ906282C; 27) JEWISH MAJOR SETUP, Pack Number DYNJ909261A; 28) SET UP, Pack Number DYNJ909403 ; 29) PREP TRAY , Pack Number DYNJRA1280A; 30) PREP TRAY , Pack Number DYNJRA1424 ; 31) NERVE BLOCK/W , Pack Number DYNJRA1424H; 32) PREP TRAY, Pack Number DYNJRA1498B; 33) PREP TRAY , Pack Number DYNJRA1583C; 34) PREP TRAY , Pack Number DYNJRA1760 ; 35) PREP TRAY , Pack Number DYNJRA1774 ; 36) PREP TRAY , Pack Number DYNJRA1783 ; 37) PREP TRAY , Pack Number DYNJRA1946A; 38) WINCHESTER PREP PACK-LF , Pack Number PHS627837003 ; 39) WINCHESTER PREP PACK-LF , Pack Number PHS627837003A

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJU·April 8, 2024

Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116

FDA Recall
Open, Classified ·Beckman Coulter Inc.·Product code CDD·July 28, 2021

Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code CAD·November 18, 2024

Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code CAD·November 18, 2024

PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.

FDA Recall
Open, Classified ·Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany·Product code CDD·July 17, 2024

Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

FDA Recall
Open, Classified ·Draeger, Inc.·Product code CAD·November 24, 2025

Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code CAD·November 18, 2024

PE Centrifuge, REF: B36365, a component of the Power Express

FDA Recall
Open, Classified ·Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany·Product code CDD·July 17, 2024

Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.

FDA Recall
Open, Classified ·Draeger, Inc.·Product code CAD·November 24, 2025

Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code CAD·November 18, 2024

Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code CAD·November 18, 2024

Power Express, REF B90918

FDA Recall
Open, Classified ·Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany·Product code CDD·July 17, 2024