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High RiskFDA
Philips North America
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Medical Devices·119 affected·Jan 3, 2024
High RiskFDA
Tornier, Inc
Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
Medical Devices·50 affected·Jan 3, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical i...
Medical Devices·13 affected·Jan 3, 2024
High RiskFDA
Philips North America
Achieva XR. Model (REF) Numbers 781153, 781253.
Medical Devices·23 affected·Jan 3, 2024
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Diagnostic Devices·61 affected·Jan 3, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Medical Devices·8 affected·Jan 3, 2024
High RiskFDA
Philips North America
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
Medical Devices·23 affected·Jan 3, 2024
High RiskFDA
United Orthopedic Corporation
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE251511...
Medical Devices·0 affected·Jan 3, 2024
High RiskFDA
Stonewall Kitchen, Llc
Vermont Village Unsweetened Apple Sauce (24oz)
Food·9,027 affected·Jan 2, 2024
High RiskFDA
Kinjin Food Private Limited
Vandevi Compounded Asafoetida 50 gm, 100 gms 200 gm, 500 gm, 1 kg. Packaged in yellow plastic bottles with plastic shrink wrap blue/yello...
Food·18,580 affected·Jan 2, 2024
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-...
Oral Drugs·38,952 affected·Jan 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affec...
Medical Devices·1,993 affected·Jan 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affe...
Medical Devices·1,993 affected·Jan 2, 2024
High RiskFDA
Zimmer Surgical Inc
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Medical Devices·76 affected·Jan 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affec...
Medical Devices·13 affected·Jan 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affe...
Medical Devices·13 affected·Jan 2, 2024
High RiskFDA
Ascend Laboratories, Llc
Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distribut...
Oral Drugs·3,288 affected·Dec 29, 2023
High RiskFDA
Strides Pharma Inc.
Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distrib...
Oral Drugs·396 affected·Dec 29, 2023
High RiskFDA
Rising Pharma Holding, Inc.
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, In...
Oral Drugs·47,976 affected·Dec 29, 2023
High RiskFDA
Aesculap Inc
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Medical Devices·60 affected·Dec 29, 2023
High RiskFDA
Aesculap Inc
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
Medical Devices·53 affected·Dec 29, 2023
High RiskFDA
Seaway Pharma Inc.
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) ...
Inhaled / Nasal Drugs·7,992 affected·Dec 28, 2023
High RiskFDA
Seaway Pharma Inc.
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed...
Inhaled / Nasal Drugs·7,992 affected·Dec 28, 2023
High RiskFDA
Seaway Pharma Inc.
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bott...
Inhaled / Nasal Drugs·8,160 affected·Dec 28, 2023
High RiskFDA
Seaway Pharma Inc.
Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle...
Drugs·4,176 affected·Dec 28, 2023
High RiskFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Walt...
Drugs·69,590 affected·Dec 28, 2023
High RiskFDA
Maquet Medical Systems Usa
Bubble Sensor (REF: 70105.5720)
Medical Devices·274 affected·Dec 28, 2023
High RiskFDA
Neurologica Corporation
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Diagnostic Devices·261 affected·Dec 28, 2023
High RiskFDA
Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella...
Surgical Devices·92,515 affected·Dec 27, 2023
High RiskFDA
Truabutment Inc.
Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software V...
Medical Devices·61 affected·Dec 27, 2023
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad...
Oral Drugs·21,452 affected·Dec 26, 2023
High RiskFDA
Ge Medical Systems, Scs
Senographe Pristina
Medical Devices·180 affected·Dec 26, 2023
High RiskFDA
Ossur H / F
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Medical Devices·544 affected·Dec 26, 2023
High RiskFDA
Ge Healthcare Austria Gmbh & Co
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Diagnostic Devices·12,004 affected·Dec 22, 2023
High RiskFDA
Howmedica Osteonics Corp.
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Surgical Devices·0 affected·Dec 22, 2023
High RiskFDA
Musculoskeletal Transplant Foundation, Inc.
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Medical Devices·89 affected·Dec 22, 2023
High RiskFDA
County Fair Foods, Inc.
Popcorn Pre-Pop in 8oz Polypropylene bag packaged 20 bags to a case
Snacks & Candy·42,000 affected·Dec 21, 2023
High RiskFDA
Pharma Nobis Llc
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400...
Oral Drugs·53,268 affected·Dec 21, 2023
High RiskFDA
Pharma Nobis Llc
Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral Solution, Cherry Flavor 10 fl. oz, Distributed by Am...
Oral Drugs·24,684 affected·Dec 21, 2023
High RiskFDA
Pharma Nobis Llc
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, Distributed by: CVS Pharmacy, Inc., One CVS D...
Oral Drugs·13,344 affected·Dec 21, 2023
High RiskFDA
Pharma Nobis Llc
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 740...
Oral Drugs·7,404 affected·Dec 21, 2023
High RiskFDA
Pharma Nobis Llc
Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distributed by: Walgre...
Oral Drugs·49,716 affected·Dec 21, 2023
High RiskFDA
Cardinal Health 200, Llc
CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
Medical Devices·3,505,730 affected·Dec 21, 2023
High RiskFDA
Covidien Lp
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON...
Medical Devices·46,812 affected·Dec 21, 2023
High RiskFDA
Amd Medicom Inc.
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Medical Devices·180 affected·Dec 21, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
Medical Devices·960 affected·Dec 21, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
Medical Devices·4,200 affected·Dec 21, 2023
High RiskFDA
Medagent Inc
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. sur...
Surgical Devices·84 affected·Dec 21, 2023