Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 153 of 548
FDA Devices Moderate Apr 27, 2022
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Microbiologics Inc
FDA Devices Moderate Apr 27, 2022
Artis zee biplane, Model Number 10094141
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 27, 2022
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Abbott
FDA Devices Critical Apr 27, 2022
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
Respironics California, LLC
FDA Devices Moderate Apr 27, 2022
Artis zee multi-purpose, Model Number 10094139
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 27, 2022
Artis zee biplane MN, Model Number 10094143
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 27, 2022
Matrix Clinical Solution At-Home COVID-19 Test
Matrix Medical Network
FDA Devices Moderate Apr 27, 2022
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Abbott
FDA Devices Moderate Apr 27, 2022
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 27, 2022
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging …
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 27, 2022
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
St. Jude Medical, Cardiac Rhythm Management Division
FDA Devices Moderate Apr 27, 2022
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Qiagen Sciences LLC
FDA Devices Moderate Apr 27, 2022
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing t…
SIGHT DIAGNOSTICS LTD
FDA Devices Moderate Apr 27, 2022
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 …
GE Healthcare, LLC
FDA Devices Moderate Apr 27, 2022
Artis Q floor, Model Number 10848280
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 27, 2022
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
St. Jude Medical, Cardiac Rhythm Management Division
FDA Devices Critical Apr 27, 2022
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Medtronic Inc
FDA Devices Critical Apr 27, 2022
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, …
Respironics California, LLC
FDA Devices Moderate Apr 27, 2022
ORAcollect RNA: ORE-100
DNA Genotek Inc.
FDA Devices Moderate Apr 27, 2022
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imagi…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 27, 2022
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078,…
DNA Genotek Inc.
FDA Devices Moderate Apr 27, 2022
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Acumed LLC
FDA Devices Moderate Apr 27, 2022
Inactivated macrolide-resistant Mycoplasma genitalium
Microbiologics Inc
FDA Devices Moderate Apr 27, 2022
Artis zee ceiling, Model Number 10094137
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 20, 2022
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
GE Healthcare, LLC
FDA Devices Moderate Apr 20, 2022
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These…
B Braun Medical Inc
FDA Devices Moderate Apr 20, 2022
Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and…
Deerfield Imaging, Inc.
FDA Devices Moderate Apr 20, 2022
LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447…
Kaneka America Corp
FDA Devices Moderate Apr 20, 2022
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These…
B Braun Medical Inc
FDA Devices Moderate Apr 20, 2022
Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-…
Abbott Vascular
FDA Devices Moderate Apr 20, 2022
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, …
Philips North America, LLC
FDA Devices Moderate Apr 20, 2022
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Boston Scientific Corporation
FDA Devices Moderate Apr 20, 2022
INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
Abbott Vascular
FDA Devices Moderate Apr 20, 2022
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Luminex Corporation
FDA Devices Moderate Apr 20, 2022
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Conformis, Inc.
FDA Devices Moderate Apr 20, 2022
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Boston Scientific Corporation
FDA Devices Moderate Apr 20, 2022
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Cardinal Health 200, LLC
FDA Devices Moderate Apr 20, 2022
Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
Nextremity Solutions
FDA Devices Moderate Apr 20, 2022
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 20, 2022
Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
Nextremity Solutions
FDA Devices Moderate Apr 20, 2022
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 20, 2022
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Apr 20, 2022
Cub 2 Enclosed Bed Canopy System
Sensory Medical Inc
FDA Devices Moderate Apr 20, 2022
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Breas Medical, Inc.
FDA Devices Moderate Apr 20, 2022
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Apr 20, 2022
CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
Graphic Controls Acquisition Corporation
FDA Devices Moderate Apr 20, 2022
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Abbott Vascular
FDA Devices Moderate Apr 20, 2022
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 20, 2022
Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
Nextremity Solutions
FDA Devices Moderate Apr 20, 2022
Integra Universal Flexible Arm part number REF 1362275
Integra LifeSciences Corp.