FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 27 of 520
Philips X5-1 Transducer.
Philips Ultrasound, Inc
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA, Inc
Philips S8-3t Transducer.
Philips Ultrasound, Inc
Philips XL14-3 Transducer.
Philips Ultrasound, Inc
Philips C5-1 Transducer.
Philips Ultrasound, Inc
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
C.R. Bard Inc
Philips L12-4 Transducer.
Philips Ultrasound, Inc
Servo-n Ventilator System. Model Number: 6694800.
Maquet Critical Care AB
Change Healthcare Cardiology Hemo Software
CHANGE HEALTHCARE CANADA COMPANY
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA, Inc
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A…
Philips Respironics, Inc.
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
MEDLINE INDUSTRIES, LP - Northfield
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA, Inc
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Onkos Surgical, Inc.
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Hardy Diagnostics
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
Becton Dickinson Infusion Therapy Systems, Inc.
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
GE Medical Systems China Co., Ltd.
Spectral CT. Computed tomography X-ray system.
Philips North America Llc
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Pro…
Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Pro…
Encore Medical, LP
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Becton Dickinson Infusion Therapy Systems, Inc.
BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
Becton Dickinson & Co.
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
MEDLINE INDUSTRIES, LP - Northfield
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Becton Dickinson Infusion Therapy Systems, Inc.
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Terumo Cardiovascular Systems Corporation
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Becton Dickinson Infusion Therapy Systems, Inc.
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Limacorporate S.p.A
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calciu…
RECORDATI RARE DISEASES INC.
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Pro…
Encore Medical, LP
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Jewel Precision Sheet Metal & Machining Co, Inc.
Extended Tip Applicator, 15 CM, Box of 5.
Integra LifeSciences Corp. (NeuroSciences)
REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Becton Dickinson Infusion Therapy Systems, Inc.
Extended Tip Applicator, 8CM, Box of 5.
Integra LifeSciences Corp. (NeuroSciences)
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413;…
Beckman Coulter Inc.
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303]…
CareFusion 303, Inc.
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Pro…
Encore Medical, LP
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version …
SunMed Holdings, LLC
REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Becton Dickinson Infusion Therapy Systems, Inc.
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Jewel Precision Sheet Metal & Machining Co, Inc.
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot…
BIGFOOT BIOMEDICAL
Extended Tip Applicator 8CM, Box of 1.
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Pro…
Guangzhou Pluslife Biotech Co., Ltd.
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Orthofix Srl
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Ohio Medical Corporation
AcoSound. Model Number: LW12-BTE-M
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
Ami HTX.
Spectral Instruments Inc
UROSKOP Omnia Max. Model Number: 10762473
Siemens Medical Solutions USA, Inc
SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
Chamberlain Technologies LLC