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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin...
Medical Devices·282 affected·Jul 14, 2020
High RiskFDA
Thomas Scientific
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Medical Devices·115,800 affected·Jul 14, 2020
High RiskFDA
Flagstone Foods Llc
Wegmans PECAN BLEND Supreme Pecans, Cashews & Pistachios NET WT 16 OZ(1 LB) 454g plastic bag Ingredients: Pecans, Cashews, Dry Roasted Pi...
Food·280 affected·Jul 13, 2020
High RiskFDA
Siam Trading Inc.
Khaotan Rice Cracker, Net Wt. 150g
Bakery & Grains·50 affected·Jul 13, 2020
High RiskFDA
Bausch Health Companies, Inc.
Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuti...
Topical Drugs·35,424 affected·Jul 13, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Ch...
Diagnostic Devices·4,076 affected·Jul 13, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration i...
Diagnostic Devices·149,370 affected·Jul 13, 2020
High RiskFDA
4e Brands North America, Llc
Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier Inte...
Supplements·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10...
Supplements·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 ...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) ...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
4e Brands North America, Llc
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl...
Drugs·17,359,247 affected·Jul 11, 2020
High RiskFDA
Keryx Biopharmaceuticals, Inc.
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, ...
Oral Drugs·59,820 affected·Jul 10, 2020
High RiskFDA
Randox Laboratories, Ltd.
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Diagnostic Devices·1,497 affected·Jul 10, 2020
High RiskFDA
Maquiladora Miniara Sa De Cv
Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carre...
Topical Drugs·245,500 affected·Jul 9, 2020
High RiskFDA
Mako Surgical Corporation
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Medical Devices·12 affected·Jul 9, 2020
High RiskFDA
Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures ...
Medical Devices·25 affected·Jul 8, 2020
High RiskFDA
New Wave Endo-surgical, Corp.
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Medical Devices·295 affected·Jul 8, 2020
High RiskFDA
Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures ...
Medical Devices·25 affected·Jul 8, 2020
High RiskFDA
Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures ...
Medical Devices·25 affected·Jul 8, 2020
High RiskFDA
Kind Llc
***KIND HEALTHY GRAINS***Oats & Honey Granola with Toasted Coconut***INGREDIENTS: Oats, tapioca syrup, brown rice, cane sugar, honey, mil...
Bakery & Grains·142,273 affected·Jul 7, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., M...
Oral Drugs·64,344 affected·Jul 7, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., M...
Oral Drugs·273,060 affected·Jul 7, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Ma...
Oral Drugs·59,568 affected·Jul 7, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., M...
Oral Drugs·95,886 affected·Jul 7, 2020
High RiskFDA
Icu Medical, Inc.
APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case. UDI: (01)10840...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per p...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)1088770...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Teleflex Medical Inc
Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow di...
Medical Devices·75,320 affected·Jul 6, 2020
High RiskFDA
Gentueri Inc
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Medical Devices·13,975 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case. ...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Orthopediatrics Corp
Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilizatio...
Medical Devices·73 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)1088770...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)1088...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 mul...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Teleflex Medical Inc
Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow di...
Medical Devices·350,779 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valves, Rotating Luer...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)1088770...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifo...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case;...
Surgical Devices·1 affected·Jul 6, 2020