Skip to main content
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated
Oral Drugs·11,286 affected·May 1, 2019
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated
Oral Drugs·8,767 affected·May 1, 2019
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
Oral Drugs·138,213 affected·May 1, 2019
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated
Oral Drugs·64,362 affected·May 1, 2019
High RiskFDA
Abbott Laboratories, Inc
ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utili...
Diagnostic Devices·9 affected·May 1, 2019
High RiskFDA
Medtronic Navigation, Inc.-littleton
Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Mo...
Medical Devices·832 affected·May 1, 2019
High RiskFDA
Abbott Vascular
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Medical Devices·0 affected·May 1, 2019
CriticalFDA
B. Braun Medical, Inc.
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
Medical Devices·2,580 affected·May 1, 2019
High RiskFDA
Paximadi Co. Llc
Biscotti-Plain. Product is bulk packed in a master cardboard case and each master case contains either 48 or 36 individual biscotti. Th...
Dairy·84 affected·Apr 30, 2019
High RiskFDA
Topnotch Foods Inc
Topnotch Foods Italian Bread Crumbs: 10 lb. Net Wt.. 10 lbs. (4.54 Kg) Item number 10008: Vernon, CA 90058 Correct ingredients: ...
Dairy·7,200 affected·Apr 30, 2019
CriticalFDA
Topnotch Foods Inc
Topnotch Foods Natural Bread Crumbs: 50 lb. Net Wt. 22.68 kg. and 10 lbs. 4.54 Kg. Item number 10021: Vernon, CA Correct Ingredi...
Dairy·2,000 affected·Apr 30, 2019
High RiskFDA
Sagent Pharmaceuticals Inc
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, ...
Injectable Drugs·75,825 affected·Apr 30, 2019
High RiskFDA
Direct Rx
Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
Drugs·33 affected·Apr 30, 2019
CriticalFDA
Par Pharmaceutical, Inc.
Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 109...
Injectable Drugs·4,506 affected·Apr 30, 2019
High RiskFDA
Preferred Pharmaceuticals, Inc
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred P...
Drugs·0 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access ...
Diagnostic Devices·238,862 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family o...
Diagnostic Devices·150,887 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Standard Hypodermic Needle Item code: 8881200029
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immun...
Diagnostic Devices·95,453 affected·Apr 30, 2019
High RiskFDA
Stryker Gmbh
Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
Medical Devices·1,600 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) for use with the Access Fa...
Diagnostic Devices·418,400 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access ...
Diagnostic Devices·123,324 affected·Apr 30, 2019
High RiskFDA
Cardinal Health 200, Llc
Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314
Medical Devices·0 affected·Apr 30, 2019
High RiskFDA
Fiddyment Farms Inc
Fiddyment Farms Fiddy Fire In-Shell Pistachios 2.5 oz., 8 oz., 1 lb., 2 lb., 3 lb., 5 lb., Fiddyment Farms Fiddy Fire Pistachio In Shell ...
Food·11,681 affected·Apr 29, 2019
Medium RiskFDA
Pfizer Inc.
Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40...
Oral Drugs·100,277 affected·Apr 29, 2019
High RiskFDA
Kavo Dental Technologies Llc
DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquir...
Medical Devices·211 affected·Apr 29, 2019
High RiskFDA
Covidien Llc
MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009...
Surgical Devices·2,223,067 affected·Apr 29, 2019
High RiskFDA
Philips Ultrasound Inc
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ...
Cardiac Devices·3,146 affected·Apr 29, 2019
High RiskFDA
Oregons Wild Harvest Inc
Dried whole elderberry, Oregon s Wild Harvest brand, packaged in metalized plastic bag, net wt. 4 oz or 1 lb. Each case contains 12 bag...
Beverages·155 affected·Apr 26, 2019
High RiskFDA
Advanced Pharma Inc.
HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded D...
Injectable Drugs·560 affected·Apr 26, 2019
CriticalFDA
Pf Consumer Healthcare 1 Llc
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to pr...
Respiratory Devices·155,904 affected·Apr 26, 2019
CriticalFDA
Terumo Medical Corporation
SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835...
Surgical Devices·2,228 affected·Apr 26, 2019
High RiskFDA
Exactech, Inc.
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Medical Devices·2 affected·Apr 26, 2019
High RiskFDA
Exactech, Inc.
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Medical Devices·3 affected·Apr 26, 2019
High RiskFDA
Exactech, Inc.
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
Medical Devices·2 affected·Apr 26, 2019
CriticalFDA
Terumo Medical Corporation
Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
Medical Devices·1,481 affected·Apr 26, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceu...
Oral Drugs·0 affected·Apr 25, 2019
Medium RiskFDA
Advantice Health
Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma...
Inhaled / Nasal Drugs·111,492 affected·Apr 25, 2019
Medium RiskFDA
Advantice Health
Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Mo...
Inhaled / Nasal Drugs·111,492 affected·Apr 25, 2019