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High RiskFDA
Chattem Inc
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanoo...
Oral Drugs·129,240 affected·Mar 26, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., M...
Oral Drugs·14,863 affected·Mar 26, 2025
High RiskFDA
Sanders Candy Factory Inc
Frosted Almond; 20 lbs (bulk); No UPC# Bulk Product Code: 23208
Food·5,020 affected·Mar 25, 2025
High RiskFDA
Nader Trading, Inc.
Kashk (Whey) Ingredients: Whey, Water, Salt Nader Trading Inc., 1821 E. Dryer Road, Santa Ana, CA 92705 UPC# 685357001537
Beverages·1,008 affected·Mar 25, 2025
High RiskFDA
Mtn Ops, Llc
MTN OPS MULTI-V Men's Daily Multivitamin dietary supplement, 60 Capsule Bottle (30 Serving). Manufactured exclusively for MTN OPS, LLC, ...
Produce·7,546 affected·Mar 25, 2025
High RiskFDA
Conformis Inc.
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Medical Devices·16 affected·Mar 25, 2025
High RiskFDA
Amerisource Health Services Llc
Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only...
Oral Drugs·889 affected·Mar 24, 2025
High RiskFDA
Remedyrepack Inc.
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-...
Oral Drugs·1,858 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Master/Nova, Model Number: 781106;
Medical Devices·103 affected·Mar 24, 2025
CriticalFDA
Baxter Healthcare Corporation
Welch Allyn Connex Vital Signs Monitor (CVSM):
Medical Devices·228,412 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
SmartPath to dStream for 3.0T, Model Number: 782145;
Medical Devices·4 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
Medical Devices·12 affected·Mar 24, 2025
High RiskFDA
Boston Scientific Corporation
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a ...
Medical Devices·31 affected·Mar 24, 2025
CriticalFDA
Baxter Healthcare Corporation
Welch Allyn CONNEX Accessory Power Management Stand:
Medical Devices·114,202 affected·Mar 24, 2025
High RiskFDA
Zimmer, Inc.
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/P...
Medical Implants·158 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
SmartPath to dStream for 1.5T, Model Number: 782146;
Medical Devices·3 affected·Mar 24, 2025
High RiskFDA
Boston Scientific Corporation
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a ve...
Medical Devices·67 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.0T Omni/Stellar, Model Number: 781102;
Medical Devices·37 affected·Mar 24, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Diagnostic Devices·56 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Enterprise 1.5T, Model Number: 781145;
Medical Devices·34 affected·Mar 24, 2025
High RiskFDA
Boston Scientific Corporation
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a v...
Medical Devices·435 affected·Mar 24, 2025
High RiskFDA
Zimmer, Inc.
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Cera...
Medical Implants·215 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Omni/Stellar, Model Number: 781104;
Medical Devices·26 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 0.5T Standard, Model Number: 781101;
Medical Devices·14 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 3.0T Quasar Dual, Model Number: 781150;
Medical Devices·12 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Power/Pulsar, Model Number: 781105;
Medical Devices·121 affected·Mar 24, 2025
High RiskFDA
Barry Callebaut Usa Llc
CACAO BARRY Gianduja Noir, 5.5lbs (2.5kg) plastic bucket, 8 buckets per case.
Food·180 affected·Mar 22, 2025
High RiskFDA
Bioriginal Food & Science Corporation
Fresh Flax Oil OMEGA 3-6-9 Organic Flaxseed Oil 16 Fl oz / 473 ml, Dietary Supplement, Black HDPE plastic bottle with cap, Manufactured f...
Supplements·61 affected·Mar 21, 2025
High RiskFDA
Somerset Therapeutics Private Limited
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, M...
Injectable Drugs·4,956 affected·Mar 21, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals...
Oral Drugs·13,128 affected·Mar 21, 2025
High RiskFDA
Somerset Therapeutics Private Limited
Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, So...
Injectable Drugs·506,080 affected·Mar 21, 2025
High RiskFDA
Somerset Therapeutics Private Limited
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 088...
Injectable Drugs·240 affected·Mar 21, 2025
High RiskFDA
Somerset Therapeutics Private Limited
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873,...
Injectable Drugs·997 affected·Mar 21, 2025
High RiskFDA
Somerset Therapeutics Private Limited
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India,...
Injectable Drugs·23,960 affected·Mar 21, 2025
High RiskFDA
Ge Medical Systems, Llc
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional ...
Surgical Devices·3,472 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002
Medical Devices·1,483 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
Medical Devices·69 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part #...
Medical Devices·40,166 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002
Medical Devices·217 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B...
Medical Devices·70,627 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets w...
Medical Devices·385,920 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012
Medical Devices·1 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Co...
Medical Devices·76,407 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200
Medical Devices·383 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002
Medical Devices·815 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; ...
Medical Devices·34,187 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002
Medical Devices·15 affected·Mar 21, 2025
High RiskFDA
Phasor Health, Llc
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Medical Devices·1,064 affected·Mar 21, 2025