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High RiskFDA
Family Dollar Stores, Llc.
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate...
Drugs·840 affected·Aug 10, 2022
High RiskFDA
Family Dollar Stores, Llc.
Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. Ne...
Drugs·840 affected·Aug 10, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials ...
Injectable Drugs·13,500 affected·Aug 10, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton,...
Injectable Drugs·33,870 affected·Aug 10, 2022
High RiskFDA
Family Dollar Stores, Llc.
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Pal...
Drugs·1,680 affected·Aug 10, 2022
High RiskFDA
Nephron Sc Inc
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporat...
Injectable Drugs·5,040 affected·Aug 10, 2022
High RiskFDA
Family Dollar Stores, Llc.
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by:...
Drugs·1,400 affected·Aug 10, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 50...
Injectable Drugs·2,030 affected·Aug 10, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag,...
Injectable Drugs·294 affected·Aug 10, 2022
High RiskFDA
Family Dollar Stores, Llc.
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (85 g) UPC 0 35000...
Drugs·840 affected·Aug 10, 2022
High RiskFDA
Saranas, Inc.
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Medical Devices·953 affected·Aug 10, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Medical Devices·1,389 affected·Aug 10, 2022
High RiskFDA
Boston Scientific Corporation
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Surgical Devices·184 affected·Aug 9, 2022
High RiskFDA
Hologic, Inc
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker i...
Medical Implants·233 affected·Aug 9, 2022
High RiskFDA
Triple B Corporation
Charlie's brand perishable and refrigerated Spinach Salad With Honey Dijon Dressing, item # 028-09048, packaged in a clear hinged contain...
Beverages·4,438 affected·Aug 8, 2022
High RiskFDA
Midlab Incorporated
Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottles, Southern Prod...
Drugs·0 affected·Aug 8, 2022
High RiskFDA
Midlab Incorporated
Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b...
Drugs·892 affected·Aug 8, 2022
High RiskFDA
Ethicon, Inc.
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Medical Devices·88 affected·Aug 8, 2022
High RiskFDA
Gs Biomark Llc
CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 ...
Diagnostic Devices·639,200 affected·Aug 8, 2022
High RiskFDA
Datascope Corporation
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Surgical Devices·4,414 affected·Aug 5, 2022
High RiskFDA
Datascope Corporation
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Surgical Devices·10,427 affected·Aug 5, 2022
High RiskFDA
Datascope Corporation
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Surgical Devices·10,427 affected·Aug 5, 2022
High RiskCPSC
Lowe's Stores, The Home Depot And Hardware Stores Nationwide, And Online At Amazon.com, Lowes.com And Other Websites From April 2019 Through May 2022 For Between $600 And $820.
DeWALT Recalls Nearly 1.4 Million Miter Saws Due to Injury and Laceration Hazards
Tools·1,364,000 affected·Aug 4, 2022
High RiskFDA
That's It. Nutrition, Lcc
That's It. Dark Chocolate Raisin Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Raisins, Organic Dark Chocolate (Organ...
Dairy·0 affected·Aug 4, 2022
High RiskFDA
That's It. Nutrition, Lcc
That's It. Dark Chocolate Fig with Sea Salt Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Figs, Organic Dark Chocola...
Dairy·0 affected·Aug 4, 2022
High RiskFDA
That's It. Nutrition, Lcc
That's It. Dark Chocolate Fig Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Figs, Organic Dark Chocolate (Organic Uns...
Dairy·0 affected·Aug 4, 2022
High RiskFDA
That's It. Nutrition, Lcc
That's It. Dark Chocolate Banana Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Bananas, Organic Dark Chocolate (Organ...
Dairy·0 affected·Aug 4, 2022
High RiskFDA
That's It. Nutrition, Lcc
That's It. Dark Chocolate Date Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Dates, Organic Dark Chocolate (Organic U...
Dairy·0 affected·Aug 4, 2022
High RiskFDA
Baxter Healthcare Corporation
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only...
Injectable Drugs·85,680 affected·Aug 4, 2022
High RiskFDA
Collagen Matrix Inc
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytopla...
Medical Devices·1,336 affected·Aug 3, 2022
High RiskFDA
Merit Medical Systems, Inc.
CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CO...
Medical Devices·1,822 affected·Aug 3, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (...
Surgical Devices·136,080 affected·Aug 3, 2022
High RiskFDA
Cipla
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured ...
Ophthalmic Drugs·7,992 affected·Aug 2, 2022
High RiskFDA
Carwild Corporation
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Numb...
Medical Devices·90 affected·Aug 2, 2022
High RiskFDA
H-e-b Grocery Company, Lp Dba Heb Milk & Culture Plant #80645
HEB Creamy Creations Light 1/1 The Fat 1/3 Fewer Calories Of Regular Ice Cream Mint Chocolate Chip Ice Cream Half Gallon (1.89L) UPC 4122...
Dairy·880 affected·Aug 1, 2022
High RiskFDA
Akorn, Inc
PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Oral Drugs·14,712 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administratio...
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
Medical Devices·19,925 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
Medical Devices·9,900 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL....
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or art...
Surgical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
Medical Devices·100 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
Medical Devices·37,550 affected·Aug 1, 2022
High RiskFDA
Merchsource Llc
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength ...
Medical Devices·0 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
Medical Devices·54,050 affected·Aug 1, 2022
High RiskFDA
Randox Laboratories Ltd.
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsA...
Medical Devices·2 affected·Aug 1, 2022