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High RiskFDA
Tytek Medical Inc
TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from ...
Medical Devices·439,146 affected·Oct 5, 2020
High RiskFDA
Thera Test Laboratories, Inc.
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Medical Devices·19 affected·Oct 5, 2020
High RiskFDA
Hu Products
Primary/Retail Package labeled in part: "Hu; CHOCOLATE-COVERED HUNKS CASHEWS + VANILLA BEAN; VEGAN; ORGANIC; PALEO; Net Wt. 4 oz (113g); ...
Dairy·136 affected·Oct 2, 2020
High RiskFDA
Marksans Pharma Limited
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-...
Oral Drugs·64,590 affected·Oct 2, 2020
High RiskFDA
Medichem S.a.
Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0
Drugs·60,000 affected·Oct 2, 2020
High RiskFDA
Marksans Pharma Limited
Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap La...
Oral Drugs·368,976 affected·Oct 2, 2020
High RiskFDA
Desert Premium Group, Llc
Trader Joe's Hatch Valley Salsa, 12 oz. jars packed into trays of 12 and shrink-wrapped, UPC: 0053 6806, Dist. & Sold Exclusively By: Tra...
Food·680 affected·Oct 1, 2020
High RiskFDA
Epitope Diagnostics, Inc.
EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-CO...
Medical Devices·2,886 affected·Oct 1, 2020
High RiskFDA
Bard Peripheral Vascular Inc
Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percuta...
Surgical Devices·281 affected·Oct 1, 2020
High RiskFDA
Microbiologics Inc
KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-S...
Medical Devices·271 affected·Oct 1, 2020
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immuno...
Diagnostic Devices·691 affected·Sep 30, 2020
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals w...
Diagnostic Devices·651 affected·Sep 30, 2020
High RiskFDA
Merz North America, Inc.
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of ca...
Medical Implants·2,051 affected·Sep 30, 2020
High RiskFDA
J .r. Simplot Company
TRADER JOE S TRADER POTATO TOTS is frozen potatoes, SKU # 94904, retail bag has net wt. 2 lbs. Product is packaged in plastic bag. TR...
Frozen Food·3,696 affected·Sep 29, 2020
High RiskFDA
Ge Inspection Technologies Llc
v|tome|x L Series non-destructive testing cabinet x-ray systems
Medical Devices·0 affected·Sep 29, 2020
High RiskFDA
Livanova Usa Inc
VNS Therapy¿ AspireSR¿ Generator
Medical Devices·134 affected·Sep 28, 2020
High RiskFDA
Taylor Farms Tennessee, Inc.
Marketside brand Cranberry Walnut Salad in 4.5 oz. plastic bowl with poly film lidding (6 bowls per case). UPC: 583243601
Produce·605 affected·Sep 26, 2020
High RiskFDA
Cardinal Health 200, Llc
Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of...
Medical Devices·519,676 affected·Sep 25, 2020
High RiskFDA
Stryker Gmbh
Osteosynthesis Compression Staple EasyClip
Medical Devices·121,517 affected·Sep 25, 2020
High RiskFDA
Quidel Corporation
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Medical Devices·8,628 affected·Sep 25, 2020
High RiskFDA
Exactech, Inc.
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Medical Devices·25 affected·Sep 25, 2020
High RiskFDA
Capital Seaboard
Gracie's Pointe frozen raw shrimp. 1. 8/12 Count Per Pound Tail On, UPC: 849558095034 2. 21/25 Count Per Pound Tail Off, UPC: 84955809...
Seafood·700 affected·Sep 24, 2020
High RiskFDA
Aa Products Inc
SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A....
Topical Drugs·1,392 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-806...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm Number: 00-8065-952-32
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Numb...
Medical Devices·0 affected·Sep 24, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical ...
Surgical Devices·62 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-32
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 45mm Item Number: 00-8065-...
Medical Implants·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 59 mm Number: 00-8065-956-32
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 43 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-28
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Boston Scientific Corporation
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Pros...
Medical Implants·24,064 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-26
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Numb...
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-32
Medical Devices·412 affected·Sep 24, 2020
High RiskFDA
Zimmer Biomet, Inc.
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 43mm Item Number: 00-8065-54...
Medical Implants·412 affected·Sep 24, 2020