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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Ge Healthcare, Llc
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioiso...
Medical Devices·7 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/C...
Medical Devices·583 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/C...
Medical Devices·187 affected·Dec 10, 2020
High RiskFDA
Sentec Ag
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of ...
Respiratory Devices·15 affected·Dec 10, 2020
High RiskFDA
Accuray Incorporated
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of ra...
Medical Devices·8 affected·Dec 10, 2020
High RiskFDA
Biogen Ma Inc.
Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufacture...
Oral Drugs·5,307 affected·Dec 9, 2020
High RiskFDA
Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc
Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC....
Oral Drugs·2,170 affected·Dec 9, 2020
High RiskFDA
Morton Grove Pharmaceuticals, Inc.
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (47...
Oral Drugs·127,392 affected·Dec 9, 2020
High RiskFDA
Riverpoint Medical, Llc
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Medical Devices·3,060 affected·Dec 9, 2020
High RiskFDA
Becton Dickinson & Company
BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a...
Medical Devices·105,880 affected·Dec 9, 2020
High RiskFDA
Shilpa Medicare Limited
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufac...
Injectable Drugs·35,931 affected·Dec 8, 2020
High RiskFDA
Shilpa Medicare Limited
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharma...
Oral Drugs·4,166 affected·Dec 8, 2020
High RiskFDA
Shilpa Medicare Limited
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufac...
Injectable Drugs·6,560 affected·Dec 8, 2020
High RiskFDA
Shilpa Medicare Limited
Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufacture...
Injectable Drugs·2,008 affected·Dec 8, 2020
High RiskFDA
Shilpa Medicare Limited
Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic...
Injectable Drugs·2,064 affected·Dec 8, 2020
High RiskFDA
Shilpa Medicare Limited
Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharma...
Oral Drugs·2,611 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to...
Medical Devices·103,475 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging...
Medical Devices·34,825 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to...
Medical Devices·60,425 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging t...
Medical Devices·31,900 affected·Dec 8, 2020
High RiskFDA
Philips Home Healthcare Solution
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Diagnostic Devices·91 affected·Dec 8, 2020
High RiskFDA
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a...
Surgical Devices·3,858 affected·Dec 8, 2020
High RiskFDA
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component o...
Surgical Devices·3,165 affected·Dec 8, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex Loss of Resistance Device, REF 100/398/000
Medical Devices·3,420 affected·Dec 8, 2020
High RiskFDA
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of...
Surgical Devices·1,926 affected·Dec 8, 2020
High RiskFDA
The Magstim Company Limited
Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cran...
Surgical Devices·7 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging...
Medical Devices·0 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging...
Medical Devices·34,650 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging...
Medical Devices·69,275 affected·Dec 8, 2020
High RiskFDA
Avkare Inc.
Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
Oral Drugs·38,715 affected·Dec 7, 2020
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial ND...
Injectable Drugs·1,324,072 affected·Dec 7, 2020
High RiskFDA
Oto Med Inc
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a sucti...
Medical Devices·5,092 affected·Dec 7, 2020
High RiskFDA
Carl Zeiss Meditec Ag
IOLMaster 700
Medical Devices·613 affected·Dec 7, 2020
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: ...
Oral Drugs·15,144 affected·Dec 3, 2020
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by...
Oral Drugs·22,848 affected·Dec 3, 2020
High RiskFDA
Flowers Foods (corporate Offices)
CANYON BAKEHOUSE GLUTEN FREE BAGELS EVERYTHING NET WT. 14 OZ (396g) Canyon Bakehouse, LLC Johnstown, CO 80534 UPC 8 53584 00221 8
Food·384 affected·Dec 2, 2020
High RiskFDA
Flowers Foods (corporate Offices)
CANYON BAKEHOUSE GLUTEN MOUNTAIN WHITE BREAD NET WT. 18oz (1lb 2oz) 510g Canyon Bakehouse, LLC Johnstown, CO 80534 UPC 8 53584 00200 3
Bakery & Grains·1,024 affected·Dec 2, 2020
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the...
Medical Devices·685 affected·Dec 2, 2020
High RiskFDA
Boston Scientific Corporation
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Medical Devices·7,093 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product ...
Diagnostic Devices·1,095 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Medical Devices·11,296 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713
Medical Devices·31 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091
Medical Devices·197 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
Medical Devices·589 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
Medical Devices·170 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product U...
Diagnostic Devices·2,405 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product ...
Diagnostic Devices·1,588 affected·Dec 2, 2020