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High RiskFDA
American Contract Systems Inc
TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
Medical Devices·24 affected·May 15, 2024
High RiskFDA
American Contract Systems Inc
BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
Medical Devices·552 affected·May 15, 2024
High RiskFDA
American Contract Systems Inc
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U
Medical Devices·27 affected·May 15, 2024
High RiskFDA
American Contract Systems Inc
ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
Medical Devices·129 affected·May 15, 2024
High RiskFDA
American Contract Systems Inc
ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
Medical Devices·6 affected·May 15, 2024
High RiskFDA
American Contract Systems Inc
TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
Medical Devices·85 affected·May 15, 2024
High RiskFDA
Imprimis Njof, Llc
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimi...
Ophthalmic Drugs·4,280 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injectio...
Injectable Drugs·38,060 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 W...
Injectable Drugs·165,920 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46...
Injectable Drugs·18,980 affected·May 14, 2024
High RiskFDA
American Regent, Inc.
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd f...
Injectable Drugs·4,136 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1...
Injectable Drugs·74,440 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF...
Injectable Drugs·39,700 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OF...
Ophthalmic Drugs·136,005 affected·May 14, 2024
High RiskFDA
Imprimis Njof, Llc
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. ...
Injectable Drugs·14,180 affected·May 14, 2024
High RiskFDA
Greiner Bio-one North America, Inc.
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Medical Devices·1,008,000 affected·May 14, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals In...
Oral Drugs·13,296 affected·May 13, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc...
Oral Drugs·2,400 affected·May 13, 2024
High RiskFDA
American Regent, Inc.
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American...
Injectable Drugs·2,352 affected·May 13, 2024
High RiskFDA
Golden State Medical Supply Inc.
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-...
Oral Drugs·21,655 affected·May 13, 2024
High RiskFDA
Carefusion 303, Inc.
BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK...
Medical Devices·677 affected·May 13, 2024
High RiskFDA
Svs Llc
Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination be...
Medical Devices·155,540 affected·May 13, 2024
High RiskFDA
Carefusion 303, Inc.
BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS ...
Medical Devices·3,002 affected·May 13, 2024
High RiskFDA
Sight Diagnostics Ltd
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC ana...
Diagnostic Devices·7,450 affected·May 13, 2024
High RiskFDA
Aesculap Inc
Aeos Robotic Digital Microscope, Product Code: PV010
Medical Devices·19 affected·May 13, 2024
High RiskFDA
Young Dental Manufacturing I, Llc
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Medical Devices·534 affected·May 13, 2024
High RiskFDA
Hp Hood (lafargeville)
Price Chopper Fat Free Cottage Cheese with Pineapple Added 16oz plastic tub.
Dairy·753 affected·May 10, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 0743...
Oral Drugs·3,480 affected·May 10, 2024
High RiskFDA
Preferred Pharmaceuticals, Inc.
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Drugs·66 affected·May 10, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07...
Oral Drugs·11,976 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardio...
Medical Devices·45,828 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material ...
Medical Devices·306,000 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic sur...
Medical Devices·341,532 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue,...
Medical Devices·56,952 affected·May 10, 2024
High RiskFDA
Ion Beam Applications S.a.
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumo...
Medical Devices·2 affected·May 10, 2024
High RiskFDA
Stryker Sustainability Solutions
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, ...
Surgical Devices·6 affected·May 10, 2024
High RiskFDA
Ethicon, Inc.
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for o...
Medical Devices·55,296 affected·May 10, 2024
High RiskFDA
Beaver Visitec International, Inc.
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
Medical Devices·1,300 affected·May 10, 2024
High RiskFDA
New Classic Cooking Llc
Veggies Made Great brand Broccoli Cheddar Breakfast Potato Bakes. Net Wt. 36 OZ (2.25 LB) 1.02 KG. UPC: 70486300103. Frozen product. Indi...
Frozen Food·10,544 affected·May 9, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SO...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
Stryker Gmbh
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Medical Devices·39 affected·May 9, 2024
High RiskFDA
Sol-millennium Medical Inc.
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle asid...
Medical Devices·0 affected·May 9, 2024
High RiskFDA
First Source Inc
First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
Medical Devices·680 affected·May 9, 2024
High RiskFDA
Remote Diagnostic Technologies Ltd.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Cardiac Devices·1,745 affected·May 9, 2024
High RiskFDA
Echonous Inc
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
Diagnostic Devices·272 affected·May 9, 2024
High RiskFDA
Della Fattoria, Llc
Della Fattoria Seeded Wheat
Food·115 affected·May 8, 2024