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High RiskFDA
Maquet Cardiovascular, Llc
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Cardiac Devices·334 affected·Jun 28, 2023
High RiskFDA
Alcon Research, Ltd.
Alcon Custom Pak
Medical Devices·1,682,351 affected·Jun 28, 2023
High RiskFDA
Zimmer, Inc.
Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation an...
Medical Devices·75 affected·Jun 27, 2023
High RiskFDA
Pegasus Foods, Inc.
Cream Cheese Rangoon NET WT: 5.00 LB. (2.26 KG) CT/CS: 100 PS (5 TRAYS X 20 PCS UPC: (01)10664383187016(15)112823(10)0601233A1W package i...
Dairy·38,887 affected·Jun 26, 2023
High RiskFDA
Strides Pharma Inc.
Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limi...
Oral Drugs·2,700 affected·Jun 26, 2023
High RiskFDA
Preferred Pharmaceuticals, Inc.
Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-co...
Oral Drugs·541 affected·Jun 26, 2023
High RiskFDA
Digisonics, Inc
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Medical Devices·32 affected·Jun 26, 2023
High RiskFDA
Paragon Vision Sciences, Inc
ISee Ortho-K Lens
Medical Devices·83,542 affected·Jun 26, 2023
High RiskFDA
Paragon Vision Sciences, Inc
Fargo Ortho-K Lens
Medical Devices·18,820 affected·Jun 26, 2023
High RiskFDA
Cargill, Inc Corporate Headquarters
Cargill Tripotassium Citrate Monohydrate packaged in 50 lb. paper bag. Product item: SKU 100105392, TPC GNLR 50LB BG KH FCC
Food·10,000 affected·Jun 23, 2023
High RiskFDA
Cargill, Inc Corporate Headquarters
Cargill Trisodium Citrate Dihydrate packaged in 50 lb. paper bags and 2,000 lb. supersacks. Product item ids: 1. SKU 100002299, TSC DI...
Food·1,610,900 affected·Jun 23, 2023
High RiskFDA
Kramer Laboratories, Inc.
Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), ...
Drugs·0 affected·Jun 23, 2023
High RiskFDA
Amerisource Health Services Llc
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: Am...
Oral Drugs·4,971 affected·Jun 23, 2023
High RiskFDA
Kramer Laboratories, Inc.
Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc....
Drugs·0 affected·Jun 23, 2023
High RiskFDA
Microtek Medical Inc.
Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/cas...
Medical Devices·9,293 affected·Jun 23, 2023
High RiskFDA
Scholly Fiberoptic Gmbh
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into...
Medical Devices·98 affected·Jun 23, 2023
High RiskFDA
Cytrellis Biosystems, Inc.
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles ...
Medical Devices·127 affected·Jun 23, 2023
High RiskFDA
Jost Chemical Co
Zinc Sulfate Monohydrate, USP, Powder. Net Wt: 55 lb / 25 kg. Jost Chemical 8150 Lackland, St. Louis, MO 63114. Caution: For Manufac...
Food·9,680 affected·Jun 22, 2023
High RiskFDA
Alembic Pharmaceuticals, Inc.
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. ...
Topical Drugs·2,844 affected·Jun 22, 2023
High RiskFDA
Scican Ltd.
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by mea...
Medical Devices·19 affected·Jun 22, 2023
High RiskFDA
Wilson-cook Medical Inc.
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for e...
Medical Devices·402 affected·Jun 22, 2023
High RiskFDA
Creganna Medical Devices
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Medical Devices·194 affected·Jun 22, 2023
High RiskFDA
Wilson-cook Medical Inc.
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for ...
Medical Devices·393 affected·Jun 22, 2023
High RiskFDA
Garelick Farms Llc
Tampico brand Mango Punch; LESS THAN 1% JUICE; 1 GAL (3.78 L); INGREDIENTS: WATER, HIGH FRUCTOSE CORN SYRUP, LESS THAN 2% OF MANGO JUICE ...
Beverages·2,156 affected·Jun 21, 2023
High RiskFDA
International Food Companies Dba International Food Products
1st phorm Level-1 Sustained Assimilation Protein. Chocolate Marshmallow. Protein Supplement. Item number 502396. Net Wt. 2.45 lbs (1....
Snacks & Candy·126 affected·Jun 21, 2023
High RiskFDA
International Food Companies Dba International Food Products
1st phorm Level-1 Sustained Assimilation Protein. Milk Chocolate. Protein Supplement. Item number 502066. Net Wt. 2.45 lbs (1.11kg) ...
Dairy·480 affected·Jun 21, 2023
High RiskFDA
Dr Reddy's Laboratories Limited
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. ND...
Oral Drugs·17,548 affected·Jun 21, 2023
High RiskFDA
Medtronic Neuromodulation
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Medical Devices·2 affected·Jun 21, 2023
High RiskFDA
Beckman Coulter, Inc.
Ringed DxI Reaction Vessels (RVs)
Medical Devices·213 affected·Jun 20, 2023
High RiskFDA
Materialise N.v.
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in ...
Surgical Devices·1 affected·Jun 19, 2023
High RiskFDA
Baxter Healthcare Corporation
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Medical Devices·122 affected·Jun 19, 2023
High RiskFDA
G.o. Corporation
Lett Blend Rom/End/Rad - All Seasons, packaged in the following sizes: 1. Produce Code 444032, 6-2lb bags per shipping case. 2. Pro...
Produce·11,500 affected·Jun 16, 2023
High RiskFDA
C&e Farms, Inc.
Romaine lettuce packed in bulk 45 pound mini-bins
Produce·2,580 affected·Jun 16, 2023
High RiskFDA
G.o. Corporation
Romaine lettuce, packaged into the following configurations and sizes: 1. Medium, Produce Code 720832, 6-2lb per shipping case. 2. ...
Produce·11,500 affected·Jun 16, 2023
High RiskFDA
G.o. Corporation
Lettuce Salad Blend Monterey, Produce Code 404709, 4-5lb bags per shipping case.
Produce·11,500 affected·Jun 16, 2023
High RiskFDA
The Harvard Drug Group
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Surve...
Oral Drugs·3,876 affected·Jun 16, 2023
High RiskFDA
Stellex/cf Houston, Llc
Wegmans single serve snack tray (5.7oz) packaged in a clear square plastic packaging with fruit, almonds and cheese 6 trays per case
Dairy·321 affected·Jun 15, 2023
High RiskFDA
Megadyne Medical Products, Inc.
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suct...
Medical Devices·241,457 affected·Jun 15, 2023
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: ...
Medical Devices·153 affected·Jun 14, 2023
High RiskFDA
Diasorin Molecular Llc
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Di...
Medical Devices·47,878 affected·Jun 14, 2023
High RiskFDA
K.c. Pharmaceuticals, Inc
Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bottle, packaged in...
Ophthalmic Drugs·397,430 affected·Jun 13, 2023
High RiskFDA
K.c. Pharmaceuticals, Inc
Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG h...
Ophthalmic Drugs·341,568 affected·Jun 13, 2023
High RiskFDA
Randox Laboratories Ltd.
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Diagnostic Devices·37 affected·Jun 13, 2023
High RiskFDA
Wright Medical Technology, Inc.
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Medical Devices·106 affected·Jun 13, 2023
High RiskFDA
Wow Factor Desserts
WOW! Factor Desserts Berry Burst Slab Cake. Weight 2x8.15lbs UPC:10778463085373 Packaged in paper cartons.
Bakery & Grains·333 affected·Jun 12, 2023
High RiskFDA
S. Martinelli Harvest Facility
Martinelli's Gold Medal 100% Apple Juice 10 oz. glass bottles, 24 units per case Apple shaped glass bottles Shelf stable UPC: 041244000098
Beverages·2,387 affected·Jun 12, 2023
High RiskFDA
Supplement Manufacturing Partner, Inc.
Havasu Beetroot Powder, 11.5 oz.
Food·1,501 affected·Jun 12, 2023
High RiskFDA
Ferring Pharmaceuticals Inc
Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufa...
Drugs·0 affected·Jun 12, 2023