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High RiskFDA
Inari Medical
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
Surgical Devices·318 affected·Mar 23, 2020
High RiskFDA
Amys Kitchen Inc
Amy's Kitchen gluten Free Vegetable Lasagna, UK Microwave or oven bake - keep frozen Item # 000374, UPC 0 042272 003747 net weight ...
Produce·7,496 affected·Mar 20, 2020
CriticalFDA
Tiffany Food Corp.
HUANGFUSHANZHEN; Dried Mushroom; Net Weight: 170G/6 OZ; Ingredient: Dried Mushroom; PRODUCT OF CHINA; SOLE AGENT: TIFFANY FOOD CORP; UPC:...
Food·1,500 affected·Mar 20, 2020
CriticalFDA
Winter Gardens Quality Foods, Inc.
Whole Foods Vodka Sauce, 6-16 oz. containers.
Food·489 affected·Mar 20, 2020
High RiskFDA
Physio-control, Inc.
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The L...
Cardiac Devices·173,459 affected·Mar 20, 2020
RecallFDA
Utak Laboratories Inc
Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Contr...
Diagnostic Devices·1,395 affected·Mar 20, 2020
High RiskFDA
The Kroger Co
PRIVATE SELECTION FROZEN BLACKBERRIES in 16 oz. bags, 10 bags per case. UPC: 0001111087809 UPC: 0001111087808
Produce·1,789 affected·Mar 19, 2020
High RiskFDA
The Kroger Co
PRIVATE SELECTION FROZEN BERRY MEDLEY in 16 oz. (10 bags per case) and 48 oz. bags (6 bags per case). UPC: 0001111079120
Produce·8,499 affected·Mar 19, 2020
High RiskFDA
Jubilant Draximage Inc
DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draxim...
Injectable Drugs·473 affected·Mar 19, 2020
High RiskFDA
Filltech Usa, Llc
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 m...
Drugs·4,790 affected·Mar 19, 2020
High RiskFDA
Edge Pharma, Llc
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL ...
Injectable Drugs·48 affected·Mar 19, 2020
High RiskFDA
Edge Pharma, Llc
Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECT...
Injectable Drugs·71 affected·Mar 19, 2020
High RiskFDA
Pai Holdings, Llc. Dba Pharmaceutical Associates Inc
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Asso...
Oral Drugs·7,416 affected·Mar 19, 2020
High RiskFDA
Filltech Usa, Llc
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) t...
Drugs·4,919 affected·Mar 19, 2020
High RiskFDA
Aseltines
Aseltines 100% JUICE Apple Cider 1/2 gallon UPC 5169600064 and 1 gallon UPC 5169600128
Beverages·3,816 affected·Mar 18, 2020
High RiskFDA
Lindt & Sprungli (usa), Inc.
Lindt & Sprungli (USA), Inc.; Excellence 85% Cocoa Dark Chocolate; Net WT 3.5OZ (100g)
Snacks & Candy·174,288 affected·Mar 18, 2020
High RiskFDA
Aurobindo Pharma Usa Inc.
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
Oral Drugs·26,625 affected·Mar 18, 2020
High RiskFDA
Aurobindo Pharma Usa Inc.
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., D...
Oral Drugs·57,337 affected·Mar 18, 2020
High RiskFDA
Aurobindo Pharma Usa Inc.
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., D...
Oral Drugs·14,194 affected·Mar 18, 2020
High RiskFDA
Aurobindo Pharma Usa Inc.
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-10...
Oral Drugs·2,101 affected·Mar 18, 2020
High RiskFDA
Aurobindo Pharma Usa Inc.
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road E...
Oral Drugs·8,040 affected·Mar 18, 2020
High RiskFDA
Aurobindo Pharma Usa Inc.
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ ...
Oral Drugs·14,707 affected·Mar 18, 2020
High RiskFDA
Aurobindo Pharma Usa Inc.
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
Oral Drugs·56,208 affected·Mar 18, 2020
High RiskFDA
Aurobindo Pharma Usa Inc.
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
Oral Drugs·26,976 affected·Mar 18, 2020
High RiskFDA
Aurobindo Pharma Usa Inc.
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., D...
Oral Drugs·4,332 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM I...
Medical Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Sc...
Diagnostic Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT ...
Medical Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under ...
Medical Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-le...
Diagnostic Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
Cardiac Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·2,500 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
Medical Devices·21 affected·Mar 17, 2020
High RiskFDA
Radiometer Medical Aps
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Medical Devices·269 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
Medical Devices·12 affected·Mar 17, 2020
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
Medical Devices·125,196 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·1,929 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
Medical Devices·32,760 affected·Mar 17, 2020
High RiskFDA
Radiometer Medical Aps
safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
Medical Devices·5 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
Medical Devices·4,320 affected·Mar 17, 2020
High RiskFDA
Radiometer Medical Aps
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
Medical Devices·1,314 affected·Mar 17, 2020
High RiskFDA
Bard Peripheral Vascular Inc
Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The dev...
Medical Devices·8,170 affected·Mar 17, 2020
High RiskFDA
Becton Dickinson & Company
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Surgical Devices·655 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·700 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·34,785 affected·Mar 17, 2020
High RiskFDA
Rayner Intraocular Lenses Limited
RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to b...
Medical Devices·2,425 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·16,393 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·9,137 affected·Mar 17, 2020