Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 108 of 548
FDA Drug Moderate Aug 9, 2023
fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, …
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Aug 9, 2023
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA …
Central Admixture Pharmacy Services Inc
FDA Drug Moderate Aug 9, 2023
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, …
Central Admixture Pharmacy Services Inc
FDA Devices Moderate Aug 9, 2023
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Johnson & Johnson Surgical Vision, Inc.
FDA Devices Moderate Aug 9, 2023
Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilizat…
Zimmer, Inc.
FDA Devices Moderate Aug 9, 2023
Azurion 7 M20. X-ray Image guided Therapy System.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Aug 9, 2023
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular a…
Materialise N.V.
FDA Devices Moderate Aug 9, 2023
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.…
Siemens Medical Solutions USA, Inc.
FDA Devices Moderate Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for a…
Olympus Corporation of the Americas
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ6571…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressu…
Scican Ltd.
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROBE COVER PACK, Model Number: D…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PACK, Model Nu…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic re…
Wilson-Cook Medical Inc.
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. EGG RETRIEVAL PACK, Model Number:…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: D…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X…
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
FDA Devices Moderate Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomi…
Olympus Corporation of the Americas
FDA Devices Moderate Aug 9, 2023
Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; …
Microtek Medical Inc.
FDA Devices Moderate Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical st…
Olympus Corporation of the Americas
FDA Devices Moderate Aug 9, 2023
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Creganna Medical Devices
FDA Devices Moderate Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical…
Olympus Corporation of the Americas
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model Number: DYN…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems…
NeuMoDx Molecular Inc
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: D…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Covidien, LLC
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Mode…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number:…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Nu…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I;…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number:…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHE…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Philips North America
FDA Devices Moderate Aug 9, 2023
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
Maquet Cardiovascular, LLC
FDA Devices Moderate Aug 9, 2023
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for car…
Maquet Cardiovascular, LLC
FDA Devices Moderate Aug 9, 2023
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Maquet Cardiovascular, LLC
FDA Devices Moderate Aug 9, 2023
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
GE OEC Medical Systems, Inc
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CD…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number:…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic r…
Wilson-Cook Medical Inc.
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, M…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A;…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE I…
GE OEC Medical Systems, Inc