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CriticalFDA
Pacific Medical Group Inc.
Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Co...
Medical Devices·6,481 affected·Sep 11, 2019
CriticalFDA
Pacific Medical Group Inc.
Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Paci...
Medical Devices·466 affected·Sep 11, 2019
CriticalFDA
Pacific Medical Group Inc.
Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Coro...
Medical Devices·6,797 affected·Sep 11, 2019
CriticalFDA
Medtech Sas
Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film...
Medical Devices·93 affected·Sep 10, 2019
CriticalFDA
Hy-vee
Hy-Vee Mealtime Fried Rice in a 16 oz. black plastic container with clear plastic lid
Food·330 affected·Sep 9, 2019
CriticalFDA
Darmerica, Llc
Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 710...
Drugs·1 affected·Sep 6, 2019
CriticalFDA
Euroline Foods Llc
TAINY VOSTOKA DRY FRUIT MIX QUINCE COMPOTE 17.65oz (500 gram); Container code# 27032019; UPC code 4605932006203.
Produce·260 affected·Sep 3, 2019
CriticalFDA
Hiland Dairy Foods
One-Half Gallon Hiland Dairy Lemonade UPC: 72060-00519-6 packaged in plastic bottle and Pint Hiland Dairy Lemonade UPC: 72060-00524-0 p...
Dairy·928 affected·Aug 30, 2019
CriticalFDA
Plastikon Healthcare Llc
Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count...
Drugs·1,433 affected·Aug 30, 2019
CriticalFDA
Krasnyi Oktyabr Inc. Usa
TAINY VOSTOKA ASSORTED DRIED FRUITS - QUINCE packaged in 500gram (17.65oz), clear plastic package marked with container code #24 02 2019...
Produce·740 affected·Aug 23, 2019
CriticalFDA
Krasnyi Oktyabr Inc. Usa
TAINY VOSTOKA ASSORTED DRIED FRUITS -APPLE were distributed nationwide in retail stores and through mail orders. The product comes in 50...
Produce·800 affected·Aug 23, 2019
CriticalFDA
Great One Trading Inc.
QQ Fish brand Mushroom Fish Ball, 200g
Seafood·40 affected·Aug 22, 2019
CriticalFDA
Great One Trading Inc.
QQ Fish brand Tofu Style Fried Fish Cake, 200g
Seafood·52 affected·Aug 22, 2019
CriticalFDA
Livanova Usa Inc
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Medical Devices·1,687 affected·Aug 22, 2019
CriticalFDA
Whole Foods Market
Decorated Red Apple Cookies sold in display case in retail stores
Bakery & Grains·4,880 affected·Aug 20, 2019
CriticalFDA
Dole Fresh Vegetables Inc
Dole Baby Spinach: 6 oz. (170 g) plastic bag, UPC 0-71430-00964-2, SKU 320; 10 oz. (283 g) clamshell, UPC 0-71430-00016-8, SKU 2337 ...
Produce·14,790 affected·Aug 9, 2019
CriticalFDA
Ruleau Bros, Inc.
Door County Whitefish Smoked Whitefish Pate 8oz plastic tub UPC 8 55356 00402 4 Keep Refrigerated 12 retail units per wholesale case
Seafood·250 affected·Jul 30, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, ...
Medical Devices·57,181 affected·Jul 30, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF ...
Medical Devices·3,375,808 affected·Jul 30, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, RE...
Medical Devices·1,805,730 affected·Jul 30, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-2...
Medical Devices·278,142 affected·Jul 30, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 m...
Medical Devices·170,740 affected·Jul 30, 2019
CriticalFDA
Teleflex Medical
Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway ...
Medical Devices·7,963 affected·Jul 30, 2019
CriticalFDA
Teleflex Medical
Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Us...
Medical Devices·1,391,004 affected·Jul 30, 2019
CriticalFDA
Harvest Sensations, Llc
Fresh basil packaged in plastic bags, each weighing one pound. (No label)
Food·937 affected·Jul 27, 2019
CriticalFDA
Mountain Mel's Essential Goods Llc
Peaceful Baby For Colic & Teething Discomfort Herbal Tea, packaged loose leaf in aluminum tin, net weight 2 oz or 56.5 grams. UPC: 7 9963...
Beverages·28 affected·Jul 25, 2019
CriticalFDA
Mountain Mel's Essential Goods Llc
Diges-Teas Herbal Tea, packaged loose leaf in aluminum tin, net weight 2 oz or 56.5 grams. UPC: 7 99632 05665 2. The label is read in ...
Beverages·21 affected·Jul 25, 2019
CriticalFDA
Mountain Mel's Essential Goods Llc
The Milk Lady's Herbal Tea, packaged loose leaf in aluminum tin, net weight 2 oz or 56.5 grams. UPC: 7 99632 05658 4. The label is r...
Dairy·10 affected·Jul 25, 2019
CriticalFDA
Ch Guenther & Sons, Inc
Williams Original Chili Seasoning, Net Wt. 1 OZ, Williams Foods, Inc. Lenexa, KS, UPC 0 41149 01100 7
Food·94 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-36...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Inf...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Pr...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: B...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require perio...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:1...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Allergan Plc
Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set S...
Medical Implants·4,026,287 affected·Jul 24, 2019
CriticalFDA
Elevation Foods
Archer Farms egg salad packaged in 12oz plastic cup with lid, 6 cups per case, refrigerated
Produce·572 affected·Jul 19, 2019
CriticalFDA
The Cookie Dough Cafe
The Cookie Dough Cafe - Chocolate chip chilled gourmet edible cookie dough; 1.6 oz bars, packaged in plastic wrappers, 16 bars per wholes...
Bakery & Grains·16,080 affected·Jul 19, 2019
CriticalFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm FDR Go Plus mobile X-ray system
Medical Devices·174 affected·Jul 19, 2019
CriticalFDA
Mountain Rose Inc. Dba Mountain Rose Herbs
Fennel Whole Seed was packaged in a clear plastic bag or poly-woven bags sold in bulk form, net weight ranges from 4 ounces to 50 pounds,...
Food·552 affected·Jul 18, 2019
CriticalFDA
The Crystal Spoon Corp.
Top Chef Meals Grilled Bison Burger best used by date between 5/4/19-6/30/19 Unit Size: 6 and 8 oz sizes Container Description: Pl...
Food·485 affected·Jul 16, 2019
CriticalFDA
Pita Pal Foods Lp
PitaPal Mezza Sundried Tomato Hummus 11 oz. UPC 851351007336 packaged in Plastic tub with clear lid with green rim.
Produce·24 affected·Jul 15, 2019
CriticalFDA
Pita Pal Foods Lp
PitaPal Edamame Dip with Pretzels 4.1 oz. UPC 851351007091 packaged in Clear tub with clear lid with green rim.
Food·36 affected·Jul 15, 2019
CriticalFDA
Pita Pal Foods Lp
PitaPal Organic Cilantro Jalapeno Hummus 10 oz. UPC 851570003348 packaged in Plastic tub with clear lid with green rim.
Food·24 affected·Jul 15, 2019
CriticalFDA
Pita Pal Foods Lp
PitaPal Texas Spicy Hummus 10 oz. UPC 851570003614 packaged in Plastic tub with clear lid with green rim; PitaPal Texas Spicy Hummus 5 l...
Food·190 affected·Jul 15, 2019