FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 16 of 520
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Abbott
Model Number U128, VALITUDE CRT-P EL MRI
Boston Scientific Corporation
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
Olympus Corporation of the Americas
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
Olympus Corporation of the Americas
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Abbott
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch…
Baxter Healthcare Corporation
FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
Ferno-Washington Inc
Model Number L231, PROPONENT DR EL MRI Pacemaker
Boston Scientific Corporation
TENACIO Pump without InhibiZone; UPN: 72404420;
Boston Scientific Corporation
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
Olympus Corporation of the Americas
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18…
BioPro, Inc.
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Ethicon Endo-Surgery Inc
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
Olympus Corporation of the Americas
Model Number L101, ESSENTIO DR SL Pacemaker
Boston Scientific Corporation
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17A…
American Contract Systems Inc.
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 21248…
American Contract Systems Inc.
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimete…
Baxter Healthcare Corporation
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
Olympus Corporation of the Americas
Cardiac Workstation 5000; Model Number: 860439;
Philips North America
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMO…
BioPro, Inc.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-i…
Baxter Healthcare Corporation
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
Olympus Corporation of the Americas
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
Abbott
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Boston Scientific Corporation
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
Olympus Corporation of the Americas
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVE…
American Contract Systems Inc.
Model Number U226, VISIONIST CRT-P EL
Boston Scientific Corporation
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
Olympus Corporation of the Americas
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec In…
Percussionaire Corporation
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Olympus Corporation of the Americas
Product: STA Liatest D-Di; REF: 00515;
Diagnostica Stago, Inc.
TENACIO Pump with InhibiZone; UPN: 72404429;
Boston Scientific Corporation
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Pro…
Spacelabs Healthcare, Inc.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), No…
Baxter Healthcare Corporation
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
Olympus Corporation of the Americas
PROPONENT SR SL (Model L200)
Boston Scientific Corporation
Model Number U228, VISIONIST CRT-P EL MRI
Boston Scientific Corporation
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
Boston Scientific Corporation
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Baxter Healthcare Corporation
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Prod…
Kico Knee Innovation Company
Model Number L221 PROPONENT DR EL Pacemaker
Boston Scientific Corporation
Medical convenience kits IHDC30R D AND C PACK
American Contract Systems Inc.
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Acti…
Baxter Healthcare Corporation
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer…
Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centime…
Baxter Healthcare Corporation
Basic Biopsy Tray, Item Number NMBP44L
American Contract Systems Inc.
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47…
Baxter Healthcare Corporation
Model Number L131, ESSENTIO DR EL MRI Pacemaker
Boston Scientific Corporation
ACCOLADE DR EL MRI (Model L331)
Boston Scientific Corporation
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Pro…
Spacelabs Healthcare, Inc.