Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,606 total recalls
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069
Medline Industries, LP
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
Smith & Nephew, Inc.
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Mod
TMJ Solutions Inc
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Numbe
Medline Industries, LP
Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 1.5MM TIP OVERALL LENGTH 7-3/4" (
Carefusion 2200 Inc
ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STE
ZOLL Circulation, Inc.
Bodor P and C series laser cutting machines
Jinan Bodor Cnc Machine Co Ltd
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Fi
Heartware, Inc.
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm.
SEDECAL SA
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A
B Braun Medical Inc
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Microbiologics Inc
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Cytocell Ltd.
Menopause (FSH) 2 Tests
GET TESTED INTERNATIONAL AB
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm
Mozarc Medical US LLC
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Appli
Fujirebio Diagnostics, Inc.
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Becton Dickinson Infusion Therapy Systems Inc.
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic
Medline Industries, LP
Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Abbott Medical
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Philips Respironics, Inc.
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Luminex Corporation
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self
New Standard Device Inc
DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
Universal Meditech Inc.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Remote Diagnostic Technologies Ltd.
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic e
Medline Industries, LP
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT
Philips North America Llc
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Siemens Healthcare Diagnostics, Inc.
Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
CooperVision, Inc.
Anesthesia Circuit Kit Coax 1, MP02730
Draeger Medical, Inc.
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