171 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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High Speed Cell Saver5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
FDA Recall
Terminated
·Haemonetics Corporation·Product code CAC·October 21, 2019
CS5/5+ Fastpacks, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
FDA Recall
Terminated
·Haemonetics Corporation·Product code CAC·October 21, 2019
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code CAC·September 18, 2023
Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code CAC·September 18, 2023
Haemonetics OrthoPAT System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
FDA Recall
Terminated
·Haemonetics Corporation·Product code CAC·July 13, 2018
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
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (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
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (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
LFS Flat screen support arm systems without 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 Support Arm Model Numbers
FDA Recall
Open, Classified
·DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan·Product code FSY·August 23, 2023
Aurora Series, Aurora 7 lighthead; Models: LED7 (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