Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 80 of 548
FDA Devices Moderate May 1, 2024
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw syste…
SEASPINE ORTHOPEDICS CORPORATION
FDA Devices Moderate May 1, 2024
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
Howmedica Osteonics Corp.
FDA Devices Moderate May 1, 2024
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
LEICA BIOSYSTEMS NUSSLOCH GMBH
FDA Devices Moderate May 1, 2024
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
Howmedica Osteonics Corp.
FDA Devices Moderate May 1, 2024
Alinity m System, Part Number: 08N53-002
Abbott Molecular, Inc.
FDA Devices Moderate May 1, 2024
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, …
EBI, LLC
FDA Devices Critical May 1, 2024
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c…
Biomerieux Inc
FDA Devices Critical May 1, 2024
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculatur…
ROUTE 92 MEDICAL INC
FDA Devices Moderate May 1, 2024
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
Howmedica Osteonics Corp.
FDA Devices Moderate May 1, 2024
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Siemens Medical Solutions USA, Inc.
FDA Devices Moderate May 1, 2024
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
Howmedica Osteonics Corp.
FDA Devices Critical May 1, 2024
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and …
ROUTE 92 MEDICAL INC
FDA Devices Moderate May 1, 2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
Quidel Corporation
FDA Devices Moderate May 1, 2024
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
Parker Laboratories, Inc.
FDA Devices Moderate Apr 24, 2024
Ingenia 1.5T S, Magnetic Resonance System.
Philips North America Llc
FDA Devices Critical Apr 24, 2024
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Philips Respironics, Inc.
FDA Devices Moderate Apr 24, 2024
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Unomedical A/S
FDA Devices Moderate Apr 24, 2024
Achieva 1.5T, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Intera 1.5T Omni/Stellar, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Achieva 3.0T, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
Masimo Corporation
FDA Devices Moderate Apr 24, 2024
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
ACTIM OY
FDA Devices Critical Apr 24, 2024
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
SonarMed Inc
FDA Devices Moderate Apr 24, 2024
GYROSCAN T5-NT, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Intera 1.5T, Magnetic Resonance System.
Philips North America Llc
FDA Devices Critical Apr 24, 2024
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed Inc
FDA Devices Moderate Apr 24, 2024
Intera 1.5T Achieva Nova, Magnetic Resonance System.
Philips North America Llc
FDA Devices Critical Apr 24, 2024
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed Inc
FDA Devices Critical Apr 24, 2024
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Outset Medical, Inc.
FDA Devices Moderate Apr 24, 2024
Intera 1.5T Achieva IT Nova, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Intera 1.0T Omni/Stellar, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
GYROSCAN ACS-NT, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4…
Smiths Medical ASD Inc.
FDA Devices Moderate Apr 24, 2024
Achieva XR, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Ingenia 1.5T CX, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surg…
Baxter Healthcare Corporation
FDA Devices Moderate Apr 24, 2024
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Smiths Medical ASD Inc.
FDA Devices Moderate Apr 24, 2024
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surg…
Baxter Healthcare Corporation
FDA Devices Moderate Apr 24, 2024
Ingenia Elition S, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 24, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Randox Laboratories Ltd.
FDA Devices Moderate Apr 24, 2024
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
Masimo Corporation
FDA Devices Moderate Apr 24, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Randox Laboratories Ltd.
FDA Devices Moderate Apr 24, 2024
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peri…
Cook Incorporated
FDA Devices Moderate Apr 24, 2024
Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.
Philips North America Llc
FDA Devices Moderate Apr 24, 2024
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
SURGICAL SPECIALTIES
FDA Devices Critical Apr 24, 2024
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed Inc
FDA Devices Moderate Apr 24, 2024
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surg…
Baxter Healthcare Corporation
FDA Devices Moderate Apr 24, 2024
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular appl…
Cook Incorporated