Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 46 of 548
FDA Devices Moderate Jan 1, 2025
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-R…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jan 1, 2025
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Encore Medical, LP
FDA Devices Moderate Jan 1, 2025
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Noah Medical
FDA Devices Moderate Jan 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals …
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jan 1, 2025
O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jan 1, 2025
DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jan 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as a…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jan 1, 2025
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using t…
Abbott Medical
FDA Devices Moderate Jan 1, 2025
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jan 1, 2025
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation cathet…
Abbott Vascular Inc
FDA Devices Moderate Jan 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jan 1, 2025
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
O&M HALYARD, INC.
FDA Devices Moderate Jan 1, 2025
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
Abbott Vascular Inc
FDA Devices Moderate Jan 1, 2025
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
Limacorporate S.p.A
FDA Devices Moderate Jan 1, 2025
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jan 1, 2025
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU D…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jan 1, 2025
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Moximed, Inc.
FDA Devices Moderate Jan 1, 2025
Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Jan 1, 2025
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Braemar Manufacturing, LLC
FDA Devices Moderate Jan 1, 2025
RUMMELL, Medline Item No. ST006ST
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jan 1, 2025
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/…
Waldemar Link GmbH & Co. KG (Mfg Site)
FDA Devices Moderate Jan 1, 2025
FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the f…
Becton, Dickinson and Company, BD Bio Sciences
FDA Devices Moderate Dec 25, 2024
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocard…
Spacelabs Healthcare, Ltd.
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-po…
CooperSurgical, Inc.
FDA Devices Moderate Dec 25, 2024
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained s…
GE OEC Medical Systems, Inc
FDA Devices Moderate Dec 25, 2024
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMA…
MicroPort Orthopedics Inc.
FDA Devices Moderate Dec 25, 2024
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Dec 25, 2024
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthe…
Draeger Medical, Inc.
FDA Devices Moderate Dec 25, 2024
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spo…
GE OEC Medical Systems, Inc
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-pow…
CooperSurgical, Inc.
FDA Devices Moderate Dec 25, 2024
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Philips North America Llc
FDA Devices Critical Dec 25, 2024
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666…
Medtronic Neurosurgery
FDA Devices Moderate Dec 25, 2024
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Mint Medical GmbH
FDA Devices Moderate Dec 25, 2024
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Dec 25, 2024
Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are d…
Kirwan Surgical Products, LLC
FDA Devices Moderate Dec 25, 2024
Duravent Silicone Ventilation Tube. Model Number: 240075.
Olympus Corporation of the Americas
FDA Devices Moderate Dec 25, 2024
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 25, 2024
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopi…
GE OEC Medical Systems, Inc
FDA Devices Moderate Dec 25, 2024
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Mint Medical GmbH
FDA Devices Critical Dec 25, 2024
Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are de…
Kirwan Surgical Products, LLC
FDA Devices Moderate Dec 25, 2024
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo),…
Augustine Temperature Management, LLC
FDA Devices Critical Dec 25, 2024
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipol…
Kirwan Surgical Products, LLC
FDA Devices Moderate Dec 25, 2024
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the pat…
Spacelabs Healthcare, Ltd.
FDA Devices Moderate Dec 25, 2024
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Dec 25, 2024
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use i…
Kirwan Surgical Products, LLC
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electri…
CooperSurgical, Inc.
FDA Devices Moderate Dec 25, 2024
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Augustine Temperature Management, LLC
FDA Devices Moderate Dec 25, 2024
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intend…
CooperSurgical, Inc.
FDA Drug Low Dec 18, 2024
Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 man…
Biocompatibles UK, Ltd.
FDA Devices Moderate Dec 18, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Micro-X Ltd.