FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 40 of 520
Moderate Feb 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
Moderate Feb 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
Moderate Feb 5, 2025
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Refere…
Medtronic Navigation, Inc.
Moderate Feb 5, 2025
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Zimmer, Inc.
Moderate Feb 5, 2025
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Boston Scientific Corporation
Moderate Feb 5, 2025
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
MEDLINE INDUSTRIES, LP - Northfield
Moderate Feb 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
Karl Storz Endoscopy
Moderate Feb 5, 2025
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
MEDLINE INDUSTRIES, LP - Northfield
Moderate Feb 5, 2025
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The Cy…
Accuray Incorporated
Moderate Feb 5, 2025
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Boston Scientific Corporation
Moderate Feb 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
Karl Storz Endoscopy
Moderate Feb 5, 2025
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 ar…
CareFusion 303, Inc.
Moderate Feb 5, 2025
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
Boston Scientific Corporation
Moderate Feb 5, 2025
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and n…
Draeger Medical Systems, Inc.
Moderate Feb 5, 2025
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
Boston Scientific Corporation
Moderate Feb 5, 2025
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Boston Scientific Corporation
Moderate Feb 5, 2025
ARTIS One Angiographic X-Ray System
SIEMENS MEDICAL SOLUTIONS USA, INC
Moderate Feb 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
Moderate Feb 5, 2025
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC0…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Feb 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
Moderate Feb 5, 2025
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
Boston Scientific Corporation
Moderate Feb 5, 2025
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Instrumentation Laboratory
Moderate Feb 5, 2025
KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
Moderate Jan 29, 2025
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd
Critical Jan 29, 2025
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 C…
Percussionaire Corporation
Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model N…
Olympus Corporation of the Americas
Moderate Jan 29, 2025
BD Pyxis Med ES Auxiliary (AUX), REF 343
CareFusion 303, Inc.
Moderate Jan 29, 2025
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Adept Medical Ltd
Moderate Jan 29, 2025
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Stryker Corporation
Moderate Jan 29, 2025
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A…
Trinity Sterile, Inc.
Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Nu…
Olympus Corporation of the Americas
Moderate Jan 29, 2025
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
Stryker Corporation
Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model …
Olympus Corporation of the Americas
Moderate Jan 29, 2025
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Adept Medical Ltd
Moderate Jan 29, 2025
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Baxter Healthcare Corporation
Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Nu…
Olympus Corporation of the Americas
Moderate Jan 29, 2025
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy…
Stryker Corporation
Moderate Jan 29, 2025
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
MICROVENTION INC.
Moderate Jan 29, 2025
BD PCR Cartridges used with MAX System. Model Number: 437519
Becton Dickinson & Co.
Moderate Jan 29, 2025
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Medtronic Perfusion Systems
Moderate Jan 29, 2025
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Compone…
O&M HALYARD, INC.
Moderate Jan 29, 2025
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A P…
Trinity Sterile, Inc.
Moderate Jan 29, 2025
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number…
Trinity Sterile, Inc.
Moderate Jan 29, 2025
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF…
Trinity Sterile, Inc.
Moderate Jan 29, 2025
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Softwa…
Ortho-Clinical Diagnostics, INc.
Moderate Jan 29, 2025
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China…
Ortho-Clinical Diagnostics, INc.
Moderate Jan 29, 2025
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Adept Medical Ltd
Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model N…
Olympus Corporation of the Americas
Moderate Jan 29, 2025
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 …
Ortho-Clinical Diagnostics, INc.
Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model N…
Olympus Corporation of the Americas