Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 158 of 548
FDA Devices Moderate Feb 16, 2022
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Microbiologics Inc
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
Baxter Healthcare Corporation
FDA Devices Moderate Feb 16, 2022
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailin…
Synthes (USA) Products LLC
FDA Devices Moderate Feb 16, 2022
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Avanos Medical, Inc.
FDA Devices Moderate Feb 16, 2022
Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
Baxter Healthcare Corporation
FDA Devices Moderate Feb 16, 2022
KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pa…
Microbiologics Inc
FDA Devices Critical Feb 16, 2022
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
E25Bio, Inc.
FDA Devices Moderate Feb 16, 2022
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Mallinckrodt Pharmaceuticals Ireland Ltd
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic resonance i…
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging s…
GE Healthcare, LLC
FDA Devices Low Feb 16, 2022
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Microbiologics Inc
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuc…
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imagi…
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical pr…
Smith & Nephew, Inc.
FDA Devices Moderate Feb 16, 2022
QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959…
Microbiologics Inc
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Microbiologics Inc
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA …
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized micr…
Microbiologics Inc
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.
GE Healthcare, LLC
FDA Devices Moderate Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
GE Healthcare, LLC
FDA Devices Moderate Feb 9, 2022
The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity…
FEMSelect Ltd
FDA Devices Moderate Feb 9, 2022
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
FDA Devices Moderate Feb 9, 2022
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
FDA Devices Low Feb 9, 2022
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Microbiologics Inc
FDA Devices Moderate Feb 9, 2022
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 30…
LivaNova USA, Inc.
FDA Devices Low Feb 9, 2022
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(…
Microbiologics Inc
FDA Devices Moderate Feb 9, 2022
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflat…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 9, 2022
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
XTANT Medical
FDA Devices Moderate Feb 9, 2022
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
FDA Devices Moderate Feb 9, 2022
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareMana…
Philips North America Llc
FDA Devices Moderate Feb 9, 2022
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
FDA Devices Critical Feb 9, 2022
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
Baxter Healthcare Corporation
FDA Devices Low Feb 9, 2022
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Microbiologics Inc
FDA Devices Moderate Feb 9, 2022
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbe…
Covidien Llc
FDA Devices Moderate Feb 9, 2022
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 9, 2022
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
FDA Devices Moderate Feb 9, 2022
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
FDA Devices Moderate Feb 9, 2022
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
FDA Devices Moderate Feb 9, 2022
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a round…
DIXI MEDICAL USA
FDA Drug Moderate Feb 2, 2022
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge …
Edge Pharma, LLC
FDA Drug Moderate Feb 2, 2022
LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LL…
Edge Pharma, LLC