Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Cardinal Health 200, Llc
Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catal...
Medical Devices·13,351 affected·Aug 16, 2023
High RiskFDA
Cardinal Health 200, Llc
Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Steril...
Medical Devices·13,351 affected·Aug 16, 2023
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
Medical Devices·111 affected·Aug 16, 2023
High RiskFDA
Olympus Corporation Of The Americas
Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Uni...
Medical Devices·522 affected·Aug 10, 2023
High RiskFDA
Baxter Healthcare Corporation
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Medical Devices·89 affected·Aug 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigat...
Medical Devices·226 affected·Aug 10, 2023
High RiskFDA
Covidien
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Medical Devices·42,367 affected·Aug 10, 2023
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn Connex Spot Monitor
Medical Devices·2 affected·Aug 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Loc...
Medical Devices·9,961 affected·Aug 10, 2023
High RiskFDA
Ethicon, Llc
PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H4...
Medical Devices·868,363 affected·Aug 10, 2023
High RiskFDA
Olea Medical
Functional MR V1.0
Medical Devices·2 affected·Aug 10, 2023
High RiskFDA
Oculus Optikgeraete Gmbh
Oculus Pentacam AXL , Ref 70100, CE 0123
Medical Devices·364 affected·Aug 8, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Medical Devices·124,773 affected·Aug 8, 2023
High RiskFDA
Fx Shoulder
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Medical Devices·4 affected·Aug 8, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Medical Devices·124,773 affected·Aug 8, 2023
High RiskFDA
Oculus Optikgeraete Gmbh
Oculus Myopia Master , Ref 68100, CE 0123
Medical Devices·173 affected·Aug 8, 2023
High RiskFDA
Ge Medical Systems Information Technologies Inc
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
Medical Devices·81 affected·Aug 8, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high v...
Medical Devices·5,155 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum ...
Medical Devices·109 affected·Aug 7, 2023
High RiskFDA
B. Braun Medical, Inc.
B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid...
Medical Devices·604,800 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a c...
Medical Devices·224 affected·Aug 7, 2023
High RiskFDA
B. Braun Medical, Inc.
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/f...
Medical Devices·534,000 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix b...
Medical Devices·231 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone ce...
Medical Devices·16 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a...
Medical Devices·8 affected·Aug 7, 2023
High RiskFDA
Stryker Corporation
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement wi...
Medical Devices·652 affected·Aug 7, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT Chemistry Products ALKP Slides
Medical Devices·402,966 affected·Aug 5, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT Chemistry Products TBIL-ALKP Slides
Medical Devices·52,456 affected·Aug 5, 2023
CriticalFDA
Medline Industries, Lp - Northfield
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Medical Devices·18,000 affected·Aug 4, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
Medical Devices·324,451 affected·Aug 3, 2023
High RiskFDA
Philips Healthcare
Incisive CT, software version 5.0
Medical Devices·140 affected·Aug 2, 2023
High RiskFDA
Syncardia Systems Llc
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Medical Devices·114 affected·Aug 1, 2023
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 099...
Medical Devices·9,175 affected·Jul 31, 2023
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 099...
Medical Devices·9,175 affected·Jul 31, 2023
High RiskFDA
B. Braun Medical, Inc.
Perifix¿ / Epidural anesthesia set, medicated
Medical Devices·3,440 affected·Jul 31, 2023
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 099...
Medical Devices·11,574 affected·Jul 31, 2023
CriticalFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Medical Devices·9,175 affected·Jul 31, 2023
CriticalFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Medical Devices·9,175 affected·Jul 31, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Medical Devices·55 affected·Jul 31, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Medical Devices·881 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-3C160.
Medical Devices·1,004 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
Medical Devices·2,127 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
Medical Devices·1,715 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
Medical Devices·1,072 affected·Jul 27, 2023
High RiskFDA
Aomori Olympus Co., Ltd.
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Ki...
Medical Devices·1,048 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
Medical Devices·3,949 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
Medical Devices·122 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Medical Devices·4,115 affected·Jul 27, 2023