Skip to main content
High RiskFDA
Perrigo Company Plc
Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 ...
Oral Drugs·44,688 affected·Jul 27, 2021
High RiskFDA
Perrigo Company Plc
KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech Republic, Packag...
Oral Drugs·42,026 affected·Jul 27, 2021
High RiskFDA
Perrigo Company Plc
GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 count bottle, Made in the Czech Republic, Distributed by Perri...
Oral Drugs·3,168 affected·Jul 27, 2021
High RiskFDA
Perrigo Company Plc
Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Per...
Oral Drugs·89,664 affected·Jul 27, 2021
High RiskFDA
Perrigo Company Plc
berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count bottle, Made in the Czech Repu...
Oral Drugs·7,670 affected·Jul 27, 2021
High RiskFDA
Perrigo Company Plc
CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4
Oral Drugs·2,784 affected·Jul 27, 2021
High RiskFDA
Perrigo Company Plc
MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Lau...
Oral Drugs·65,796 affected·Jul 27, 2021
High RiskFDA
Versea Diagnostics Llc
FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human ven...
Medical Devices·563,290 affected·Jul 27, 2021
High RiskFDA
Clarus Medical, Llc
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Medical Devices·858 affected·Jul 27, 2021
High RiskFDA
Versea Diagnostics Llc
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antige...
Medical Implants·563,290 affected·Jul 27, 2021
High RiskFDA
Monfefo Llc
Monfefo brand Turmeric Shot; 2oz; Cold Pressed Juice Blend; packaged in glass bottle
Beverages·25 affected·Jul 26, 2021
High RiskFDA
High Performance Formulas, L.l.c. (hpf, L.l.c.)
Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF,...
Oral Drugs·14,848 affected·Jul 26, 2021
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide ...
Medical Implants·782 affected·Jul 26, 2021
High RiskFDA
Philips Respironics, Inc.
Trilogy Evo Universal, Product number DS2000X11B
Medical Devices·10,000 affected·Jul 26, 2021
High RiskFDA
Philips Respironics, Inc.
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15...
Medical Devices·101 affected·Jul 26, 2021
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide ...
Medical Implants·354 affected·Jul 26, 2021
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide...
Medical Implants·236 affected·Jul 26, 2021
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide...
Medical Implants·337 affected·Jul 26, 2021
High RiskFDA
Abbott Laboratories
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
Diagnostic Devices·4,833 affected·Jul 26, 2021
High RiskFDA
Paltop Advanced Dental Solutions Ltd
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide...
Medical Implants·16 affected·Jul 26, 2021
High RiskFDA
Professional Disposables International, Inc
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) S...
Drugs·11,039 affected·Jul 23, 2021
High RiskFDA
Professional Disposables International, Inc
PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376...
Drugs·5,477 affected·Jul 23, 2021
High RiskFDA
Professional Disposables International, Inc
PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C1...
Drugs·1,982 affected·Jul 23, 2021
High RiskFDA
Professional Disposables International, Inc
PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S4...
Drugs·51,926 affected·Jul 23, 2021
High RiskFDA
Professional Disposables International, Inc
PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10...
Drugs·53,588 affected·Jul 23, 2021
High RiskFDA
Professional Disposables International, Inc
PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -137...
Drugs·3,113 affected·Jul 23, 2021
High RiskFDA
Professional Disposables International, Inc
PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S4135...
Drugs·41,105 affected·Jul 23, 2021
High RiskFDA
Aspen Surgical Products, Inc.
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Medical Devices·124 affected·Jul 23, 2021
High RiskFDA
Boston Scientific Corporation
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Medical Devices·4,980 affected·Jul 23, 2021
High RiskFDA
Biomimetic Therapeutics, Llc
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Medical Devices·499 affected·Jul 23, 2021
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Medical Devices·326 affected·Jul 23, 2021
High RiskFDA
Mivi Neuroscience Inc
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, ...
Surgical Devices·68 affected·Jul 23, 2021
High RiskFDA
Mivi Neuroscience Inc
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm le...
Surgical Devices·491 affected·Jul 23, 2021
High RiskFDA
Hiland Dairy Foods Company Llc
Hiland 100% Pure Apple Juice From Concentrate No Sugar Added Pasteurized 4 FL OZ (118 mL) packaged in paper cartons 75 cartons per case
Beverages·436,884 affected·Jul 22, 2021
High RiskFDA
Baxter Healthcare Corporation
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management an...
Medical Devices·1,976 affected·Jul 22, 2021
High RiskFDA
Baxter Healthcare Corporation
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 S...
Medical Devices·64,275 affected·Jul 22, 2021
High RiskFDA
Implant Resource Inc
MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (...
Medical Devices·6 affected·Jul 21, 2021
High RiskFDA
Trophy Sas
CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿...
Diagnostic Devices·895 affected·Jul 21, 2021
High RiskFDA
Beckman Coulter Inc.
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
Diagnostic Devices·123 affected·Jul 21, 2021
High RiskFDA
Merit Medical Systems, Inc.
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Sing...
Medical Devices·373 affected·Jul 21, 2021
High RiskFDA
His Enterprise Inc
Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
Oral Drugs·0 affected·Jul 20, 2021
High RiskFDA
Angiodynamics, Inc.
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Medical Devices·26 affected·Jul 20, 2021
High RiskFDA
Nihon Kohden Orangemed, Inc
Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is ...
Respiratory Devices·1,999 affected·Jul 20, 2021
High RiskFDA
Angiodynamics, Inc.
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Medical Devices·16 affected·Jul 20, 2021
High RiskFDA
Teligent Pharma, Inc.
Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-014-80 ; pack...
Topical Drugs·0 affected·Jul 19, 2021
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDI...
Oral Drugs·37,560 affected·Jul 19, 2021
High RiskFDA
Teligent Pharma, Inc.
Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged ...
Topical Drugs·14,688 affected·Jul 19, 2021
High RiskFDA
Give And Go Prepared Foods (usa)
7 Eleven Selects Chocolate Chip 3pack Mini Muffins - 2.6 oz., 16 units per tray, 6 trays per case; UPC: 0 52548-62095 0
Snacks & Candy·485,304 affected·Jul 17, 2021