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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·February 11, 2026
BD Alaris PCU REF 8015
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·September 15, 2023
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·November 6, 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
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code PHC·February 18, 2025
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code PHC·February 18, 2025
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PCU·December 1, 2020
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PCU·December 1, 2020
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PCU·December 1, 2020
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PCU·December 1, 2020
AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PCU·December 1, 2020
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PCU·December 1, 2020
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Recall
Terminated
·CareFusion 303, Inc.·Product code FRN·July 21, 2015
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate Long, Left; 70-0047-S Acu-Loc VDU Plate Long, Left; 70-0048 Acu-Loc VDU Plate Long, Right; 70-0048-S Acu-Loc VDU Plate Long, Right; 70-0055 Acu-Loc Dorsal Plate, Standard, left; 70-0055-S Acu-Loc Dorsal Plate, Standard, left; 70-0056 Acu-Loc Dorsal Plate, Standard, Right; 70-0056-S Acu-Loc Dorsal Plate, Standard, Right; 70-0057 Acu-Loc Dorsal Plate, Narrow, Left; 70-0057-S Acu-Loc Dorsal Plate, Narrow, Left; 70-0058 Acu-Loc Dorsal Plate, Narrow, Right; 70-0058-S Acu-Loc Dorsal Plate, Narrow, Right; 70-0331 Divergent Radial Styloid Plate; 70-0331-S Divergent Radial Styloid Plate; 70-0334 Volar Lunate Suture Plate; 70-0334-S Volar Lunate Suture Plate; 70-0335 Dorsal Rim Buttress Plate, Right; 70-0335-S Dorsal Rim Buttress Plate, Right; 70-0336 Dorsal Rim Buttress Plate, Left; 70-0336-S Dorsal Rim Buttress Plate, Left; 70-0337 Dorsal Lunate Plate, Right; 70-0337-S Dorsal Lunate Plate, Right; 70-0338 Dorsal Lunate Plate, Left;
FDA Recall
Open, Classified
·Acumed LLC·Product code HRS·December 19, 2023
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.
FDA Recall
Open, Classified
·Stryker Corporation·Product code GCJ·January 14, 2022
Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ".
FDA Recall
Terminated
·Acumed LLC·Product code HRS·June 29, 2007
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
FDA Recall
Terminated
·Steris Corporation·Product code FEB·October 7, 2020
Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation.
FDA Recall
Terminated
·Instrumentation Industries Inc·Product code BTO·July 9, 2009
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case.
FDA Recall
Terminated
·NxStage Medical, Inc.·Product code KDI·April 14, 2004