FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 59 of 520
Moderate Sep 11, 2024
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable conc…
Mindray DS USA, Inc. dba Mindray North America
Critical Sep 11, 2024
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or …
Breas Medical, Inc.
Moderate Sep 11, 2024
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Abiomed, Inc.
Moderate Sep 11, 2024
Pump 381 Pump Set (US); Product Code: 1000080;
Abiomed, Inc.
Moderate Sep 11, 2024
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Abiomed, Inc.
Moderate Sep 11, 2024
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
Abiomed, Inc.
Moderate Sep 11, 2024
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
Beckman Coulter Biomedical GmbH
Moderate Sep 11, 2024
Impella CP Smart Assist Set; Product Code: 1000402;
Abiomed, Inc.
Moderate Sep 11, 2024
Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to a…
Mindray DS USA, Inc. dba Mindray North America
Critical Sep 11, 2024
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil …
Philips Respironics, Inc.
Moderate Sep 11, 2024
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Abiomed, Inc.
Critical Sep 11, 2024
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Fresenius Kabi USA, LLC
Moderate Sep 11, 2024
Power Express, REF B90918
Beckman Coulter Biomedical GmbH
Moderate Sep 11, 2024
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
CareFusion 303, Inc.
Moderate Sep 11, 2024
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Abiomed, Inc.
Moderate Sep 11, 2024
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination …
Beckman Coulter, Inc.
Moderate Sep 11, 2024
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Critical Sep 11, 2024
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Philips Respironics, Inc.
Moderate Sep 11, 2024
PE Centrifuge, REF: B36365, a component of the Power Express
Beckman Coulter Biomedical GmbH
Moderate Sep 11, 2024
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
Abiomed, Inc.
Moderate Sep 11, 2024
Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;
Abiomed, Inc.
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001113;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001737;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002075;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003;
Beaver Visitec International, Inc.
Critical Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code…
Smiths Medical ASD Inc.
Moderate Sep 4, 2024
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001635;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001605;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001503;
Beaver Visitec International, Inc.
Critical Sep 4, 2024
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
Abbott Diabetes Care, Inc.
Moderate Sep 4, 2024
see RES for description
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001486;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001110;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, diss…
Stryker Corporation
Moderate Sep 4, 2024
Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA032…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001338;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001624;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRA…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001501;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Howmedica Osteonics Corp.
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001775;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, …
Stryker Corporation
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001138;
Beaver Visitec International, Inc.
Moderate Sep 4, 2024
Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , P…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 4, 2024
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001200;
Beaver Visitec International, Inc.