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High RiskFDA
Fresenius Kabi Usa, Llc
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg ...
Injectable Drugs·40,375 affected·Nov 22, 2022
CriticalFDA
Philips North America Llc
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Medical Devices·566 affected·Nov 22, 2022
High RiskFDA
Randox Laboratories Ltd.
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immu...
Diagnostic Devices·115 affected·Nov 22, 2022
CriticalFDA
Philips North America Llc
Philips MR 7700 System, Model Number 782120
Medical Devices·566 affected·Nov 22, 2022
High RiskFDA
Randox Laboratories Ltd.
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems ...
Diagnostic Devices·146 affected·Nov 22, 2022
High RiskFDA
Abbott Molecular, Inc.
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Medical Devices·3,896 affected·Nov 22, 2022
High RiskFDA
Hippos And Hashbrowns
Take & Bake Sourdough Biscuits UPC 44216-26512 packaged in metal tin with clear plastic nonflexible lid
Food·114 affected·Nov 21, 2022
High RiskFDA
Hippos And Hashbrowns
Take & Bake Sweet Potato Biscuits 44216-26522 packaged in metal tin with clear plastic nonflexible lid
Food·158 affected·Nov 21, 2022
High RiskFDA
Hippos And Hashbrowns
Take & Bake Everything Biscuits UPC 44216-26532 packaged in metal tin with clear plastic nonflexible lid
Food·3 affected·Nov 21, 2022
High RiskFDA
Hippos And Hashbrowns
Take & Bake Cinnabiscuits UPC 44216-26552 packaged in metal tin with clear plastic nonflexible lid
Food·202 affected·Nov 21, 2022
High RiskFDA
Hippos And Hashbrowns
Take & Bake Maple Pecan Biscuits no UPC packaged in metal tin with clear plastic nonflexible lid
Food·18 affected·Nov 21, 2022
High RiskFDA
Hippos And Hashbrowns
Take & Bake Blueberry Biscuits no UPC packaged in metal tin with clear plastic nonflexible lid
Produce·18 affected·Nov 21, 2022
RecallFDA
Dr. Reddy's Laboratories, Inc.
Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packag...
Oral Drugs·25,176 affected·Nov 21, 2022
High RiskFDA
Becton Dickinson & Co.
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Medical Devices·9,600 affected·Nov 21, 2022
High RiskFDA
Leica Microsystems, Inc.
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
Surgical Devices·148 affected·Nov 21, 2022
High RiskFDA
Medtronic Minimed
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Medical Devices·3,235 affected·Nov 21, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Medical Devices·36 affected·Nov 18, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
Medical Devices·31,300 affected·Nov 18, 2022
High RiskFDA
Devilbiss Healthcare Llc
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Respiratory Devices·1,004,315 affected·Nov 18, 2022
CriticalFDA
Mobius Imaging, Llc
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Medical Devices·3 affected·Nov 18, 2022
High RiskFDA
Amys Kitchen Inc
Amy's Kitchen Gluten Free Bean and Cheese Burrito 5.5 oz. individually wrapped plastic packages - 12 units per case UPC - 042272-00353-2 ...
Dairy·5,134 affected·Nov 17, 2022
High RiskFDA
Phil's Power Pancake
Phil's Power Pancakes 5 oz. individually wrapped units 5 varieties, including (Chocolate Hempseed, Cranberry, Raspberry, Mango, and Date)...
Bakery & Grains·500 affected·Nov 17, 2022
CriticalFDA
Green Day Produce
Enoki Mushroom Net wt. 200g (7.05 oz.) 25 units per case UPC: 16430-69080 Keep refrigerated Product of Korea
Food·1,512 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. AC...
Medical Devices·6,420 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
Medical Devices·20 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
Medical Devices·36 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NEC...
Medical Devices·9,079 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e....
Medical Devices·11,886 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEAR...
Medical Implants·12,964 affected·Nov 17, 2022
High RiskFDA
Ottlite Technologies, Inc.
OttLite Rechargeable UVC Disinfecting Wand
Medical Devices·7,376 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOT...
Medical Devices·1,212 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY C...
Medical Devices·42,593 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
LOCAL PACK. Sterile Procedural Tray.
Medical Devices·8 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
Medical Devices·86 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
Medical Devices·15 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR ...
Medical Devices·260 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
Medical Devices·26 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
Medical Devices·160 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
Medical Devices·100 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
Medical Devices·50 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
Medical Devices·216 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR...
Medical Devices·174 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS...
Medical Devices·1,258 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
Medical Devices·36 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
Medical Devices·48 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; ...
Medical Implants·314 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
Medical Devices·12 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY...
Medical Devices·194 affected·Nov 17, 2022