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High RiskFDA
Ferring Pharmaceuticals Inc
ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demon...
Injectable Drugs·1,569 affected·Mar 11, 2021
High RiskFDA
Ferring Pharmaceuticals Inc
ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 ...
Injectable Drugs·301 affected·Mar 11, 2021
High RiskFDA
Breckenridge Pharmaceutical, Inc
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, C...
Oral Drugs·3,146 affected·Mar 11, 2021
High RiskFDA
Sagent Pharmaceuticals Inc
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intrave...
Injectable Drugs·3,716 affected·Mar 11, 2021
High RiskFDA
Liebel-flarsheim Company Llc
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Medical Devices·17 affected·Mar 11, 2021
High RiskFDA
Krishe Inc
Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
Medical Devices·441,500 affected·Mar 11, 2021
High RiskFDA
Stryker Spine
Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (5802201...
Medical Devices·169 affected·Mar 11, 2021
High RiskFDA
Krishe Inc
Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
Medical Devices·18,000 affected·Mar 11, 2021
High RiskFDA
Krishe Inc
Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
Medical Devices·10,000 affected·Mar 11, 2021
RecallCPSC
Raymour, Nebraska Furniture, Mathis Bros. Furniture, And Other Furniture Stores Nationwide From October 2020 Through January 2021 For About $200.
Hillsdale Furniture Recalls Jennings Counter and Bar Stools Due to Fall Hazard
Furniture·10,570 affected·Mar 10, 2021
RecallCPSC
Online At Amazon.com, Costco.com, Samsclub.com And Other Websites And At Lifetime Stores In Utah And Idaho From August 2016 Through November 2020 For About $90.
Lifetime Products Recalls 6-Foot Seminar Tables Due to Injury Risk
Furniture·43,000 affected·Mar 10, 2021
High RiskFDA
Tippins
Tippin's Country Gravy, Net Wt 16 OZ, Keep Refrigerated, Tippin's Gourmet Pies LLC, Kansas City, KS UPC 6 80816 12023 1 packaged in plast...
Food·46 affected·Mar 10, 2021
CriticalFDA
Sanit Technologies, Llc Dba Durisan
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technologies, LLC, 7810 2...
Drugs·42,905 affected·Mar 10, 2021
CriticalFDA
Pnhc, Llc.
heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL)...
Topical Drugs·139,806 affected·Mar 10, 2021
High RiskFDA
China Gel Inc
CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 ...
Topical Drugs·40,289 affected·Mar 10, 2021
High RiskFDA
Sanit Technologies, Llc Dba Durisan
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net C...
Drugs·8,609,863 affected·Mar 10, 2021
High RiskFDA
China Gel Inc
CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g)...
Topical Drugs·92,472 affected·Mar 10, 2021
High RiskFDA
China Gel Inc
aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 763...
Topical Drugs·3,458 affected·Mar 10, 2021
High RiskFDA
Sanit Technologies, Llc Dba Durisan
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5)...
Drugs·43,164 affected·Mar 10, 2021
CriticalFDA
Sanit Technologies, Llc Dba Durisan
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net C...
Drugs·8,609,863 affected·Mar 10, 2021
High RiskFDA
Remel Inc
Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in ...
Medical Devices·19 affected·Mar 10, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull...
Medical Devices·12 affected·Mar 10, 2021
RecallFDA
Cardinal Health Inc.
Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc.,...
Injectable Drugs·48 affected·Mar 9, 2021
High RiskFDA
Icu Medical Inc
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045...
Drugs·425,628 affected·Mar 9, 2021
CriticalFDA
Kareem Mart Inc
Kareem Chef Halva 1lb and 2lb sizes in plastic tub
Food·1,320 affected·Mar 8, 2021
RecallFDA
New Generation Wellness Inc.
Live Better vegan vitamin d-3 by CVS Health, 50 mcg (2000 IU), 40 tablets in blue PET jar, Distributed by: CVS Pharmacy, Inc. one CVS Dri...
Supplements·16,477 affected·Mar 8, 2021
High RiskFDA
Quirch Foods
Yellowfin Tuna portions Frozen IVP-CO Treated, Net WT 20 LBS, Size 1 LB.
Seafood·55 affected·Mar 8, 2021
CriticalFDA
Kareem Mart Inc
Kareem Chef Halva with Chocolate 1lb size in plastic tub
Snacks & Candy·600 affected·Mar 8, 2021
CriticalFDA
Kareem Mart Inc
Kareem Chef Halva with Pistachio 1lb and 2lb sizes in plastic tub
Food·2,412 affected·Mar 8, 2021
High RiskFDA
Akorn, Inc.
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech...
Oral Drugs·8,183 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·1,000 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing an...
Cardiac Devices·3,664 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia paci...
Cardiac Devices·702 affected·Mar 8, 2021
High RiskFDA
Arrow International Inc
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-...
Medical Devices·3,756 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pac...
Cardiac Devices·98 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·670 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ve...
Cardiac Devices·0 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing...
Cardiac Devices·779 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·499 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia p...
Cardiac Devices·3,832 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·323 affected·Mar 8, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·674 affected·Mar 5, 2021
High RiskFDA
Boston Scientific Corporation
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in ...
Surgical Devices·52 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·8 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·15 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·132 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·33 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·0 affected·Mar 5, 2021