FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 44 of 520
Moderate Jan 1, 2025
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Siemens Healthcare Diagnostics, Inc.
Moderate Jan 1, 2025
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
MEDLINE INDUSTRIES, LP - Northfield
Moderate Jan 1, 2025
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in hu…
Beckman Coulter, Inc.
Moderate Jan 1, 2025
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic de…
Abbott Vascular Inc
Moderate Jan 1, 2025
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
MEDLINE INDUSTRIES, LP - Northfield
Critical Jan 1, 2025
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Nova Biomedical Corporation
Moderate Jan 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as…
Siemens Healthcare Diagnostics, Inc.
Moderate Jan 1, 2025
STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
MEDLINE INDUSTRIES, LP - Northfield
Moderate Jan 1, 2025
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Encore Medical, LP
Moderate Jan 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as…
Siemens Healthcare Diagnostics, Inc.
Critical Jan 1, 2025
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient te…
Nova Biomedical Corporation
Moderate Jan 1, 2025
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Hologic, Inc.
Moderate Jan 1, 2025
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 …
3M Company - Health Care Business
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
Moderate Jan 1, 2025
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Encore Medical, LP
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
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.
Moderate Jan 1, 2025
O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
MEDLINE INDUSTRIES, LP - Northfield
Moderate Jan 1, 2025
DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
MEDLINE INDUSTRIES, LP - Northfield
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.
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
Moderate Jan 1, 2025
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
MEDLINE INDUSTRIES, LP - Northfield
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
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.
Moderate Jan 1, 2025
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
O&M HALYARD, INC.
Moderate Jan 1, 2025
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
Abbott Vascular Inc
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
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
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
Moderate Jan 1, 2025
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Moximed, Inc.
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
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
Moderate Jan 1, 2025
RUMMELL, Medline Item No. ST006ST
MEDLINE INDUSTRIES, LP - Northfield
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)
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
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.
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.
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
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.
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
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.
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
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.
Moderate Dec 25, 2024
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Philips North America Llc
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
Moderate Dec 25, 2024
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Mint Medical GmbH
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
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
Moderate Dec 25, 2024
Duravent Silicone Ventilation Tube. Model Number: 240075.
Olympus Corporation of the Americas
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