BEUDAMED
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    One Step P in vitro diagnostic test REF: 8194

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code JIR·April 2, 2026

    One Step pH in vitro diagnostic test REF: 31I4P

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code CEN·April 2, 2026

    QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code CHH·April 2, 2026

    Uric Acid in vitro diagnostic test REF: 31H0P

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code KNK·April 2, 2026

    One Step UTI in vitro diagnostic test REF: 3374

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code LJX·April 2, 2026

    One Step 10A in vitro diagnostic test

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code MVO·April 2, 2026

    One Step K in vitro diagnostic test REF: 81A4

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code JIN·April 2, 2026

    Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF5454 and IF5454EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF222222-B, IF222222EL and IN222222EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light, 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, IN22LH and IF22(EL).

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3022B. (note only the 22'' lighthead is affected.)

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN3022EL and IF3022EL. (note only the 22'' lighthead is affected).

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IN302222EL, IF302222-B, IN30AR2222EL and IN30TV2222EL. (note only the 22'' lightheads are affected).

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC

    FDA Recall
    Open, Classified ·DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan·Product code FSY·August 23, 2023

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Recall
    Open, Classified ·DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan·Product code FSY·July 9, 2024