Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 126 of 548
FDA Devices Moderate Feb 15, 2023
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DE…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 15, 2023
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
Roche Molecular Systems, Inc.
FDA Devices Moderate Feb 15, 2023
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f.…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 15, 2023
Sterile Procedural Trays, labeled as the following: LS MS PACK
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Feb 15, 2023
GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inc…
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
FDA Devices Moderate Feb 15, 2023
Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 15, 2023
TRACH PACK. Sterile Procedural Tray.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 15, 2023
Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 15, 2023
Identity Shoulder System Resection Planer 35mm Resection Planer
Zimmer, Inc.
FDA Devices Moderate Feb 15, 2023
ANCILLARY PACK-LF. Sterile Procedural Tray.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 8, 2023
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
W L Gore & Associates, Inc.
FDA Devices Moderate Feb 8, 2023
Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Turbett Surgical, Inc.
FDA Devices Moderate Feb 8, 2023
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in …
Medtronic Perfusion Systems
FDA Devices Moderate Feb 8, 2023
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Carbon Medical Technologies, Inc.
FDA Devices Moderate Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
Medtronic Perfusion Systems
FDA Devices Moderate Feb 8, 2023
Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Feb 8, 2023
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7…
Smiths Medical ASD Inc.
FDA Devices Moderate Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Card…
Medtronic Perfusion Systems
FDA Devices Moderate Feb 8, 2023
NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0…
NovaSignal Corp.
FDA Devices Moderate Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
Medtronic Perfusion Systems
FDA Devices Moderate Feb 8, 2023
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in …
Medtronic Perfusion Systems
FDA Devices Critical Feb 8, 2023
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Smiths Medical ASD Inc.
FDA Devices Moderate Feb 8, 2023
Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 8, 2023
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including mid…
Biomet, Inc.
FDA Devices Moderate Feb 8, 2023
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Feb 8, 2023
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21…
Smiths Medical ASD Inc.
FDA Devices Moderate Feb 8, 2023
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego …
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Feb 8, 2023
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
SynCardia Systems LLC
FDA Devices Moderate Feb 8, 2023
AxiEM" Non-Invasive Patient Tracker
Medtronic Navigation, Inc.
FDA Devices Moderate Feb 8, 2023
Non-sterile procedural trays labeled as CRANI, 2 per case
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 8, 2023
Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 8, 2023
(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: …
Biomet, Inc.
FDA Devices Moderate Feb 8, 2023
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Turbett Surgical, Inc.
FDA Devices Moderate Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
Medtronic Perfusion Systems
FDA Devices Moderate Feb 8, 2023
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
CooperSurgical, Inc.
FDA Devices Critical Feb 8, 2023
CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF …
Smiths Medical ASD Inc.
FDA Devices Moderate Feb 8, 2023
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
MEDLINE INDUSTRIES, LP - Northfield
FDA Drug Moderate Feb 1, 2023
GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML SY…
Pharmacy Innovations
FDA Drug Moderate Feb 1, 2023
BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Pharmacy Innovations
FDA Drug Moderate Feb 1, 2023
Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Pharmacy Innovations
FDA Drug Moderate Feb 1, 2023
HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Pharmacy Innovations
FDA Devices Moderate Feb 1, 2023
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 501…
SunMed Holdings, LLC
FDA Devices Moderate Feb 1, 2023
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Meridian Bioscience Inc
FDA Devices Moderate Feb 1, 2023
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal…
TELEFLEX LLC
FDA Devices Critical Feb 1, 2023
Getinge Flow-e Anesthesia System, Part No. 6887900
Getinge Usa Sales Inc
FDA Devices Moderate Feb 1, 2023
FUSION Dual Pump Packs, REF: OPO73
Johnson & Johnson Surgical Vision, Inc.
FDA Devices Critical Feb 1, 2023
Getinge Flow-c Anesthesia System, Part No. 6887700
Getinge Usa Sales Inc
FDA Devices Critical Feb 1, 2023
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Getinge Usa Sales Inc
FDA Devices Moderate Feb 1, 2023
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibi…
Biomet, Inc.
FDA Devices Moderate Feb 1, 2023
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Future Diagnostics Solutions B.V.