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High RiskFDA
Olympus Corporation Of The Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and fo...
Surgical Devices·254 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model...
Medical Devices·371 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Mod...
Medical Implants·15,323 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE...
Cardiac Devices·76,870 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, M...
Medical Devices·36 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTA...
Medical Devices·7,462 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number...
Medical Devices·3,431 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number:...
Cardiac Devices·46,124 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, M...
Medical Devices·9,319 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PA...
Surgical Devices·135 affected·May 15, 2023
High RiskFDA
Ge Oec Medical Systems, Inc
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Medical Devices·2 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Mode...
Cardiac Devices·43,149 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, M...
Surgical Devices·4,900 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID ...
Medical Devices·80 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
Medical Devices·192 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Numbe...
Medical Devices·6,733 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN C...
Medical Devices·83,541 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: ...
Medical Devices·15,945 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model ...
Surgical Devices·16,143 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model ...
Medical Implants·100,549 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model ...
Medical Devices·1,231,480 affected·May 15, 2023
High RiskFDA
Ge Oec Medical Systems, Inc
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE P...
Medical Devices·16 affected·May 15, 2023
High RiskFDA
Olympus Corporation Of The Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical inter...
Medical Devices·1,158 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANG...
Cardiac Devices·97,677 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE...
Medical Implants·134,514 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model ...
Medical Devices·624 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model...
Medical Devices·29,126 affected·May 15, 2023
High RiskFDA
Empower Clinic Services Llc Dba Empower Pharmacy
ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W...
Injectable Drugs·504 affected·May 12, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
Medical Devices·189,221 affected·May 12, 2023
High RiskFDA
Full Vision Inc
TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA
Medical Devices·95 affected·May 12, 2023
High RiskFDA
Full Vision Inc
TRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929
Medical Devices·96 affected·May 12, 2023
High RiskFDA
Ossur H / F
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adap...
Medical Devices·4,190 affected·May 12, 2023
High RiskFDA
Full Vision Inc
TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926
Medical Devices·565 affected·May 12, 2023
High RiskFDA
Boston Scientific Neuromodulation Corporation
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression Syste...
Surgical Devices·21,533 affected·May 12, 2023
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manuf...
Injectable Drugs·1,352,475 affected·May 11, 2023
High RiskFDA
Revive Rx Llc Dba Revive Rx Pharmacy
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, ...
Drugs·45 affected·May 11, 2023
High RiskFDA
Julie's Real Foods Llc
Julie's Real JR Bar Dark Chocolate Grain-Free Granola Bar, Net Wt 1.4 oz (40g), UPC 857628006705, packaged and sold in a 6 Pack Box to co...
Bakery & Grains·21,582 affected·May 10, 2023
High RiskFDA
Julie's Real Foods Llc
Julie's Real JR Bar Cinnamon Vanilla Bean Grain-Free Granola Bar, Net Wt 1.4 oz (40g), UPC 857628006699, packaged and sold in a 6 Pack Bo...
Bakery & Grains·22,290 affected·May 10, 2023
High RiskFDA
Permobil
PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-3...
Medical Devices·18,905 affected·May 10, 2023
High RiskFDA
Fresenius Kabi Usa, Llc
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Medical Devices·6 affected·May 10, 2023
High RiskFDA
B. Braun Medical Inc
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical In...
Injectable Drugs·1,380 affected·May 9, 2023
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1...
Drugs·3,232 affected·May 9, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, I...
Oral Drugs·5,344 affected·May 9, 2023
High RiskFDA
Qiagen Gmbh
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the foll...
Respiratory Devices·368 affected·May 9, 2023
High RiskFDA
Virtual Radiologic Corp.
vRad PACS with Mammography
Medical Devices·8 affected·May 9, 2023
High RiskFDA
Sodexo Operations, Llc
simply to go Strawberry Yogurt Parfaits, 8.53oz, UPC 477088125794; packaged in plastic cups
Dairy·50,343 affected·May 8, 2023
High RiskFDA
Sodexo Operations, Llc
simply to go Blueberry Yogurt Parfaits, 8.53oz, UPC 477088156552 and 477088150550; packaged in plastic cups
Dairy·23,059 affected·May 8, 2023
High RiskFDA
Galt Medical Corporation
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Medical Devices·490 affected·May 8, 2023