Skip to main content
High RiskFDA
Stryker Corporation
Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Need...
Medical Devices·19 affected·Sep 13, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides com...
Surgical Devices·12 affected·Sep 12, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per car...
Medical Devices·342 affected·Sep 12, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
Surgical Devices·237 affected·Sep 12, 2023
High RiskFDA
Olympus Corporation Of The Americas
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) ...
Medical Devices·2,496 affected·Sep 12, 2023
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Diagnostic Devices·36 affected·Sep 12, 2023
High RiskFDA
Raysearch Laboratories Ab
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical i...
Medical Devices·2 affected·Sep 12, 2023
High RiskFDA
Cerebelly Inc
Cerebelly Smart Bar; Apple Kale flavor; 5 pk and 7 pk; ambient storage
Food·152,655 affected·Sep 11, 2023
High RiskFDA
The Little Oak Company Ltd
LittleOak Natural Goat Milk Follow On Infant Formula (Stage 2); packaged in 800g (1.8lbs) tin cans - six cans per case.
Dairy·15,600 affected·Sep 11, 2023
High RiskFDA
Cerebelly Inc
Cerebelly Smart Bar; Strawberry Beet flavor; 5 pk and 7 pk; ambient storage
Produce·152,655 affected·Sep 11, 2023
High RiskFDA
Cerebelly Inc
Cerebelly Smart Bar; Blueberry Banana flavor; 5 pk; ambient storage
Produce·152,655 affected·Sep 11, 2023
High RiskFDA
Cerebelly Inc
Cerebelly Smart Bar; Carrot Date flavor; 5 pk; ambient storage
Food·152,655 affected·Sep 11, 2023
High RiskFDA
The Little Oak Company Ltd
LittleOak Natural Goat Milk Infant Formula (Stage 1); packaged in 800g (1.8lbs) tin cans - six cans per case.
Dairy·14,100 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Roi Cps Llc
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Medical Devices·103 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005
Surgical Devices·2,321 affected·Sep 11, 2023
High RiskFDA
Lipari Foods Operating Company, Llc.
IO Inspired Organics Organic Raw Walnuts, 5oz bag, UPC 8 63669 74200 7, 9 bags per wholesale case
Food·17 affected·Sep 9, 2023
High RiskFDA
Ge Healthcare
Universal Viewer Workflow Manager, Image processing radiological system
Medical Devices·57 affected·Sep 8, 2023
High RiskFDA
Ge Medical Systems China Co., Ltd.
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Medical Devices·1,638 affected·Sep 8, 2023
High RiskFDA
Omega Medical Imaging, Inc.
Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
Medical Devices·31 affected·Sep 8, 2023
High RiskFDA
Edwards Lifesciences, Llc
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Surgical Devices·185 affected·Sep 7, 2023
High RiskFDA
Blue Belt Technologies, Inc
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Medical Devices·56 affected·Sep 7, 2023
High RiskFDA
Lipari Foods Operating Company, Llc.
JLM Roasted Salted Pecan Halves, 10oz clear plastic container, 12 per wholesale case. Lipari number 368729, UPC 094776110049
Food·98 affected·Sep 6, 2023
High RiskFDA
Ge Medical Systems, Israel Ltd.
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imagi...
Medical Devices·5,986 affected·Sep 6, 2023
High RiskFDA
Encore Medical, Lp
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Surgical Devices·146 affected·Sep 6, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
Medical Devices·0 affected·Sep 6, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
Medical Devices·13 affected·Sep 6, 2023
High RiskFDA
Smiths Medical Asd Inc.
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Medical Devices·31,900 affected·Sep 6, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Medical Devices·35 affected·Sep 6, 2023
High RiskFDA
Be Pharmaceuticals Ag
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-1...
Injectable Drugs·41,148 affected·Sep 5, 2023
High RiskFDA
Mazor Robotics Ltd
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Medical Devices·324 affected·Sep 5, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Medical Devices·0 affected·Sep 5, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Medical Devices·0 affected·Sep 5, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Com...
Ophthalmic Drugs·8,747 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceutica...
Ophthalmic Drugs·30,490 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compa...
Ophthalmic Drugs·196,442 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company...
Ophthalmic Drugs·18,171 affected·Sep 1, 2023