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High RiskFDA
Neocis Inc.
DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the p...
Medical Implants·70 affected·May 14, 2020
High RiskFDA
Willamette Valley Pie Company, Llc.
Willamette Valley Pie Company Raspberry Rhubarb Pie, packaged in clamshells container, six containers per case. Each pie weighs 10 oz. a...
Beverages·48 affected·May 13, 2020
High RiskFDA
Willamette Valley Pie Company, Llc.
Willamette Valley Pie Company Cherry Pie, packaged in clamshells container, six containers per case. Each pie weighs 10 oz. and sold as ...
Beverages·48 affected·May 13, 2020
High RiskFDA
West-ward Columbus Inc
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx on...
Oral Drugs·68,376 affected·May 13, 2020
High RiskFDA
Johnson Sea Products, Inc.
Home Style Crab Cakes in a plastic wrapped foam tray, 12 oz. (Four, 3 oz. crab cakes per package). 12 packages per case.
Seafood·23 affected·May 12, 2020
High RiskFDA
Diasorin Molecular Llc
MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of vari...
Medical Devices·304 affected·May 12, 2020
High RiskFDA
Covidien Llc
Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery pr...
Surgical Devices·12,610 affected·May 12, 2020
High RiskFDA
Diasorin Molecular Llc
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX...
Medical Devices·13,943 affected·May 12, 2020
High RiskFDA
Covidien Llc
Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic ...
Surgical Devices·12,610 affected·May 12, 2020
High RiskFDA
Med Tec Inc
Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
Medical Devices·171 affected·May 12, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Curcumin 50mg/mL, 10 mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Curcumin, 4mg/mL, 10mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Torrent Pharma Inc.
Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130,...
Oral Drugs·6,228 affected·May 11, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use ...
Diagnostic Devices·0 affected·May 11, 2020
High RiskFDA
Biomet, Inc.
Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640,...
Medical Implants·38 affected·May 11, 2020
High RiskFDA
Ge Healthcare
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional...
Cardiac Devices·221 affected·May 8, 2020
High RiskFDA
Merge Healthcare, Inc.
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage...
Medical Devices·62 affected·May 8, 2020
High RiskFDA
Unfi General Corporate
Wild Harvest Organic Fresh Basil packaged in the following sized plastic containers: Net Wt 2 oz (57g), UPC 11535-50762, Net Wt 0.25...
Food·77 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intende...
Medical Implants·26 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use dev...
Medical Implants·76 affected·May 7, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
Medical Devices·927 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use dev...
Medical Implants·40 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the te...
Medical Implants·186 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the tem...
Medical Implants·3 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devic...
Medical Implants·400 affected·May 7, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies a...
Diagnostic Devices·230 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use d...
Medical Implants·3 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices inten...
Medical Implants·69 affected·May 7, 2020
High RiskFDA
Jindilli Beverages Llc
Milkadamia Salted Buttery Spread 8 ounces packaged in plastic tub, 6 packaged per case UPC 858045004718
Dairy·2,981 affected·May 6, 2020
High RiskFDA
Jindilli Beverages Llc
Milkadamia Unsalted Buttery Spread 8 ounces packaged in plastic tub, 6 packaged per case UPC 858045004725
Dairy·1,707 affected·May 6, 2020
High RiskFDA
Zilks Foods
Plucker's Wing Bar World Famous Wing Sauce Gochujang 12 FL OZ. (355 mL) packaged in a glass bottle
Food·288 affected·May 5, 2020
High RiskFDA
Zilks Foods
Plucker's Wing Bar World Famous Wing Sauce Hallelujah 12 FL OZ. (355 mL) packaged in a glass bottle
Food·408 affected·May 5, 2020
High RiskFDA
Zilks Foods
Plucker's Wing Bar World Famous Wing Sauce Gold Rush 12 FL OZ. (355 mL) packaged in a glass bottle
Food·468 affected·May 5, 2020
High RiskFDA
Zilks Foods
Plucker's Wing Bar World Famous Wing Sauce Vampire Killer 12 FL OZ. (355 mL) packaged in a glass bottle
Food·528 affected·May 5, 2020
High RiskFDA
Zilks Foods
Plucker's Wing Bar World Famous Wing Sauce Spicy Mandarin 12 FL OZ. (355 mL) packaged in a glass bottle
Food·468 affected·May 5, 2020
High RiskFDA
Zilks Foods
Plucker's Wing Bar World Famous Wing Sauce Sesame 12 FL OZ. (355 mL) packaged in a glass bottle
Food·180 affected·May 5, 2020
High RiskFDA
Zilks Foods
Plucker's Wing Bar World Famous Wing Sauce Teriyaki 12 FL OZ. (355 mL) packaged in a glass bottle
Food·228 affected·May 5, 2020
High RiskFDA
Mylan Institutional Llc
Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 611...
Injectable Drugs·3,010 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cervical spinal fixat...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - Product Usage: are non-cervical spinal fixat...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - Product Usage: are non-cervical spinal fixati...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixat...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - Product Usage: are non-cervical spinal fixat...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number 811M8560 - Product Usage: are non-cervical spinal fixati...
Medical Implants·3,235 affected·May 5, 2020
High RiskFDA
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number 810M6540 - Product Usage: are non-cervical spinal fixat...
Medical Implants·3,235 affected·May 5, 2020