Skip to main content
High RiskFDA
Give And Go
two-bite unicorn cupcakes 10 oz. UPC 7 70981 04417 0 Marketside unicorn cupcakes 10 oz. UPC 6 81131 10125 7
Bakery & Grains·1,142,754 affected·Nov 8, 2021
High RiskFDA
Medline Industries Inc
Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and...
Drugs·470,555 affected·Nov 8, 2021
High RiskFDA
Tolmar, Inc.
Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68
Topical Drugs·0 affected·Nov 8, 2021
High RiskFDA
Qiagen Sciences Llc
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Respiratory Devices·376 affected·Nov 8, 2021
High RiskFDA
Boston Scientific Corporation
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Medical Devices·7 affected·Nov 8, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Medical Devices·187 affected·Nov 8, 2021
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 0...
Topical Drugs·7,766 affected·Nov 4, 2021
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ ...
Topical Drugs·1,588 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Wright Medical Technology Inc
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Medical Devices·2 affected·Nov 4, 2021
High RiskFDA
Medtronic Neuromodulation
Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Mod...
Medical Implants·10 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Sector USB"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Console"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Medtronic Neuromodulation
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimu...
Medical Implants·6,406 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Ascend Laboratories Llc
Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by...
Oral Drugs·4,104 affected·Nov 3, 2021
High RiskFDA
Haag-streit Usa Inc
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Medical Devices·3 affected·Nov 3, 2021
High RiskFDA
Murray International Trading Co., Inc.
"Herbal Doctor" brand Angelicae Sinensis, Natural Herb, Net Wt. 16 oz (454 g) packaged in a green plastic bag; and 12oz (340g) packaged i...
Food·13,000 affected·Nov 2, 2021
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Medical Devices·14,447 affected·Nov 2, 2021
High RiskFDA
Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Surgical Devices·270,839 affected·Nov 2, 2021
High RiskFDA
Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Surgical Devices·364,481 affected·Nov 2, 2021
High RiskFDA
Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Surgical Devices·363,480 affected·Nov 2, 2021
High RiskFDA
Magnolia Medical Technologies, Inc.
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide N...
Medical Devices·137,200 affected·Nov 2, 2021
High RiskFDA
Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
Surgical Devices·231,219 affected·Nov 2, 2021
High RiskFDA
Cardinal Health
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Surgical Devices·17,174 affected·Nov 2, 2021
High RiskFDA
Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Surgical Devices·169,262 affected·Nov 2, 2021
High RiskFDA
Newly Weds Foods Inc
Newly Weds Foods SCAMPI SEASONING 50 lb. bag NWF product number S17571
Food·50 affected·Nov 1, 2021
High RiskFDA
Newly Weds Foods Inc
Newly Weds Foods corn dog batter 50 lb. bag NWF product number A29435
Food·5,131 affected·Nov 1, 2021
High RiskFDA
Precision Dose Inc.
Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (ND...
Oral Drugs·151,100 affected·Nov 1, 2021
High RiskFDA
Precision Dose Inc.
Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-coun...
Oral Drugs·166,920 affected·Nov 1, 2021
High RiskFDA
Human Care Usa, Inc.
Hanger-Bar 2P 45cm
Medical Devices·15 affected·Nov 1, 2021
High RiskFDA
Smith & Nephew, Inc.
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Medical Devices·38 affected·Nov 1, 2021
High RiskFDA
Randox Laboratories Ltd.
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Medical Devices·15 affected·Nov 1, 2021
High RiskFDA
Smith & Nephew, Inc.
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
Medical Devices·35 affected·Nov 1, 2021
High RiskFDA
Smith & Nephew, Inc.
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
Medical Devices·41 affected·Nov 1, 2021
High RiskFDA
Flowers Foods (corporate Offices)
Tastykake Butterscotch Krimpets 24oz (12-2ct) UPC 0 25600 00396 1; 12oz (6-2ct) UPC 0 25600 00227 8 ; 3oz UPC 0 25600 00002 1 & 2oz, UPC ...
Dairy·2,471 affected·Oct 31, 2021
High RiskFDA
Flowers Foods (corporate Offices)
Tastykake Creme Filled Krimpets 14.25oz (6-2ct) UPC 0 25600 00355 8; 3.625oz (3ct) UPC 0 25600 08637 7
Food·2,264 affected·Oct 31, 2021
High RiskFDA
Flowers Foods (corporate Offices)
Tastykake Chocolate Creme Filled Cupcakes 14.25oz, UPC 0 25600 00223 0
Bakery & Grains·3,310 affected·Oct 31, 2021
High RiskFDA
Flowers Foods (corporate Offices)
Tastykake Jelly Krimpets 12oz (6-2ct) UPC 0 25600 00228 5 & 3oz (3ct) UPC 0 25600 00025 0
Food·2,583 affected·Oct 31, 2021
High RiskFDA
Flowers Foods (corporate Offices)
Tastykake Chocolate Cupcakes 12.75oz, UPC 0 25600 00219 3
Bakery & Grains·4,626 affected·Oct 31, 2021
High RiskFDA
Puratos Corporation (hq And Innovation Center)
TK019 2017 Choc Cup Powder Blend Bag 50#. Item number 4005543
Food·119,900 affected·Oct 29, 2021
High RiskFDA
Puratos Corporation (hq And Innovation Center)
NSA Creme Cake Bag 50#. Material #4107591
Bakery & Grains·11,950 affected·Oct 29, 2021
High RiskFDA
Puratos Corporation (hq And Innovation Center)
TK006 Van Krimpet Powder Blend 50#. Item number 4107780
Food·30,350 affected·Oct 29, 2021
High RiskFDA
Puratos Corporation (hq And Innovation Center)
One Step Neutral/Vanilla Mousse Bag 25#. Material #4107486
Food·12,150 affected·Oct 29, 2021
High RiskFDA
Puratos Corporation (hq And Innovation Center)
Teg Moist'r Yellow Layer Cake Bag 50# Material #4107439
Bakery & Grains·35,850 affected·Oct 29, 2021