20 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·January 17, 2011
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·February 16, 2026
Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000 DRAIN, OCEAN BRU W/AC,S
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code CAC·September 18, 2023
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code CAC·November 27, 2018
Atrium Oasis Drain Single W / AC, Part No. 3600-100
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code CAC·November 1, 2023
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code CAC·September 5, 2023
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code CAC·December 13, 2023
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
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
RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code CAC·November 27, 2018
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
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code CAC·December 13, 2023
Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code CAD·November 18, 2024
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
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
FDA Recall
Open, Classified
·Orthosoft, Inc. dba Zimmer CAS 3300-75 Queen St Montreal Canada·Product code OLO·January 7, 2022
biokitHSV-2 Rapid Test, REF: 300028001
FDA Recall
Open, Classified
·Biokit, S.A. Avinguda De Can Montcau 7 (Barcelona) Llica D'Amunt Spain·Product code LGC·September 28, 2022