Skip to main content
High RiskFDA
Sca Pharmaceuticals
HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 700...
Injectable Drugs·3,092 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, ba...
Drugs·7,940 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only ...
Injectable Drugs·3,793 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT...
Drugs·3,239 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow R...
Drugs·13,096 affected·Dec 17, 2020
High RiskFDA
Cipla
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kur...
Oral Drugs·284,610 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainb...
Drugs·7,890 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainb...
Drugs·23,029 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow...
Injectable Drugs·9,942 affected·Dec 17, 2020
High RiskFDA
Ge Healthcare, Llc
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
Medical Devices·1,115 affected·Dec 17, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
Medical Devices·2,280 affected·Dec 17, 2020
High RiskFDA
Bioventus, Llc
EXOGEN Ultrasound Coupling Gel
Medical Devices·115,584 affected·Dec 17, 2020
High RiskFDA
Bonduelle Canada Inc.
HRV Carrot.Cubes 1/20LB/HRV DCD Cartos 1/20LB - bag in box product in a corrugated case; IQF Cartotte Cubes 3/8" 1/25LB/IQF Diced Cartos ...
Food·4,296 affected·Dec 16, 2020
High RiskFDA
Bonduelle Canada Inc.
GE Mixed Veg (4) 12/32oz/GE Mixed Veg (4) 12/32oz - packed in corrugated cases of 12 individual printed poly bags
Food·4,296 affected·Dec 16, 2020
High RiskFDA
Bonduelle Canada Inc.
HRV Carot.&Pois 1/20LB/HRV Carrot & Peas 1/20LB - bag in box product in corrugated case
Food·4,296 affected·Dec 16, 2020
High RiskFDA
Philips Ultrasound Inc
Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EP...
Diagnostic Devices·607 affected·Dec 16, 2020
High RiskFDA
Medtronic Neurosurgery
REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt ...
Medical Devices·0 affected·Dec 16, 2020
High RiskFDA
Medtronic Neurosurgery
REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt ...
Medical Devices·0 affected·Dec 16, 2020
High RiskFDA
Cook Medical Llc
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
Medical Devices·56,250 affected·Dec 16, 2020
High RiskFDA
Microbiologics Inc
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 3...
Medical Devices·59 affected·Dec 16, 2020
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum ...
Medical Devices·9,802 affected·Dec 15, 2020
High RiskFDA
Depuy Orthopaedics, Inc.
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050...
Medical Implants·14,161 affected·Dec 15, 2020
High RiskFDA
Sca Pharmaceuticals, Inc.
Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock...
Drugs·654 affected·Dec 14, 2020
High RiskFDA
Cipla
Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited ...
Injectable Drugs·2,151 affected·Dec 14, 2020
High RiskFDA
Integra Lifesciences Corp.
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shu...
Surgical Devices·85 affected·Dec 14, 2020
High RiskFDA
Prytime Medical Devices, Inc.
PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, S...
Surgical Devices·0 affected·Dec 14, 2020
High RiskFDA
K2m, Inc
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Medical Devices·248 affected·Dec 14, 2020
High RiskFDA
Bard Peripheral Vascular Inc
VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/6...
Medical Implants·23,029 affected·Dec 14, 2020
High RiskFDA
Integra Lifesciences Corp.
Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospin...
Surgical Devices·17 affected·Dec 14, 2020
High RiskFDA
Phadia Us Inc
EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum an...
Medical Devices·365 affected·Dec 14, 2020
High RiskFDA
Brainreader Aps
Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, ...
Medical Devices·43 affected·Dec 14, 2020
High RiskFDA
Bard Peripheral Vascular Inc
VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/6...
Medical Implants·12,258 affected·Dec 14, 2020
High RiskFDA
Netuno Usa, Inc.
NETUNO Caribbean Red Snapper, Net Weight 10 Lbs (4.54 Kg), Item 101229, Product Must be Fully Cooked Prior to Consumption, 1.5-2.0 LB
Food·500 affected·Dec 11, 2020
High RiskFDA
Dreyers Grand Ice Cream, Inc.
Outshine Fruit & Cream Bars - Creamy Pineapple Coconut 6 fruit and dairy bars, 14.7 fl. oz. UPC: 41548 91817 4 Distributed by Nest...
Dairy·856 affected·Dec 11, 2020
High RiskFDA
Qiagen Sciences Llc
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatmen...
Medical Devices·575 affected·Dec 11, 2020
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 ...
Medical Devices·41,598 affected·Dec 11, 2020
High RiskFDA
Baxter Healthcare Corporation
VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prola...
Medical Devices·192 affected·Dec 11, 2020
High RiskFDA
Fresenius Kabi Usa, Llc
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323...
Injectable Drugs·4,411 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of r...
Medical Devices·12 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: inte...
Medical Devices·81 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H31...
Medical Devices·52 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/tr...
Diagnostic Devices·113 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/C...
Surgical Devices·1,759 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radio...
Medical Devices·24 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radio...
Medical Devices·12 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/C...
Surgical Devices·247 affected·Dec 10, 2020
High RiskFDA
Remel Inc
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Medical Devices·637 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curv...
Surgical Devices·863 affected·Dec 10, 2020