| 15 Aug 2024 | Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226. | Fagron Compounding Services | Drug | Class II | 1 |
| 15 Aug 2024 | Great Value; 8oz Apple Juice in 6 pack; 100% Juice; packaged in 8 oz. PET plastic bottles; UPC 0-78742-29655-5 | Refresco Beverages US Inc | Food | Class II | 1 |
| 12 Aug 2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey | FDC Limited | Drug | Class II | 1 |
| 8 Aug 2024 | Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 1 |
| 8 Aug 2024 | Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30 | Teva Pharmaceuticals USA, Inc | Drug | Class II | 1 |
| 7 Aug 2024 | Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01 | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class III | 1 |
| 7 Aug 2024 | MEIJER DUNKING COOKIES CHOCOLATE CHIP, 10oz in clear plastic container. UPC 7-13733-71297-2 | Meijer Inc | Food | Class I | 1 |
| 5 Aug 2024 | Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA. | Zeco LLC | Drug | Class II | 2 |
| 2 Aug 2024 | Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064 (95079) | EMPOWER CLINIC SERVICES LLC | Drug | Class II | 1 |
| 1 Aug 2024 | Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1 | Amneal Pharmaceuticals, LLC | Drug | Class III | 1 |
| 1 Aug 2024 | Cold Smoked Capelin, 9-ounce packages, plastic trays, 34 packages per case (Best By Date:07.13.2024), 18 packages per case (Best Buy Date: 01.05.2025), UPC code4811527003360, Keep Frozen,UPC code 4811527003360 (95101) | North Fish USA, Inc. | Food | Class I | 1 |
| 31 Jul 2024 | Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05 | Granules Pharmaceuticals Inc. | Drug | Class II | 1 |
| 31 Jul 2024 | Lunds & Byerlys Fresh Guacamole Dip, Net Wt 14 oz (396g). UPC 0 72431-66072 6. Keep Refrigerated. | Metro Produce Distributors, Inc. | Food | Class I | 5 |
| 30 Jul 2024 | Boars Head Grab and Go Wedge Ham, Smoke Master Black Forest Ham, Grab and Go Sandwich, NET WT. 7.5 OZ (213 g), Plastic Container, KEEP REFRIGERATED | Publix Super Markets, Inc. | Food | Class I | 1 |
| 29 Jul 2024 | VEGAN OAT; Van Leeuwen PUMPKIN CINNAMON ROLL; NON-DAIRY FROZEN DESSERT 14 oz, (414 ml); Est. Brooklyn 2008 ingredients: oat milk (water, oats) coconut cream, cane sugar, brown sugar, unbleached wheat flour, tapioca syrup, pumpkin puree, coconut oil, cocoa butter, water, ginger, corn starch, vanilla extract, natural… (95071) | Van Leeuwen Ice Cream LLC | Food | Class I | 1 |
| 29 Jul 2024 | El Chilar, Canela Molida, Ground Cinnamon NET WT. 1.25 Oz (35g) , Spices Herbs, BOPP Bag, 12 units per cases | EL Chilar-HF, LLC | Food | Class II | 1 |
| 26 Jul 2024 | Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E Windsor, NJ 08520, NDC 55150-306-10. | Eugia US LLC | Drug | Class II | 1 |
| 25 Jul 2024 | Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A (95066) | Intrinsic Therapeutics, Inc. | Device | Class II | 1 |
| 24 Jul 2024 | 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09. | B. Braun Medical Inc | Drug | Class I | 1 |
| 24 Jul 2024 | FULL CIRCLE market COCONUTMILK CHOCOLATE ALMOND CRUNCH NON0DAIRY FROZEN DESSERT 16 FLOZ (1PT) 473 mL UPC 0 36800 46964 8 DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 (95030) | G.S. Gelato and Desserts Inc. | Food | Class II | 1 |
| 23 Jul 2024 | Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India. | FDC Limited | Drug | Class II | 1 |
| 22 Jul 2024 | SlideView VS200 slide viewer, (95028) | EVIDENT SCIENTIFIC INC | Device | Class II | 1 |
| 22 Jul 2024 | Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52. | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 22 Jul 2024 | Frozen Food Processors - Regular Cornbread Muffins packaged in 2oz corrugated cardboard boxes lined with food grade plastic bags. Keep frozen at 0F or lower until time of use. 96 individual muffins per case. | Frozen Food Processors, Inc. | Food | Class III | 2 |
| 20 Jul 2024 | Izzio Everything Sourdough. Single 24oz loaf packaged into plastic bag. 12 loaves per case. | Izzio Artisan Bakery, LLC | Food | Class II | 3 |
| 19 Jul 2024 | BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. (94943) | Biointellisense Inc. | Device | Class II | 1 |
| 19 Jul 2024 | ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011 (95069) | Inari Medical - Oak Canyon | Device | Class I | 1 |
| 19 Jul 2024 | Freshire Farms - Jalapenos packaged in plastic bags at 8oz, 18 bags per case | RS Hanline and Company Inc | Food | Class I | 6 |
| 18 Jul 2024 | BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128 | Becton Dickinson & Co. | Device | Class II | 1 |
| 18 Jul 2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, [NDC 64980-514-05]. | FDC Limited | Drug | Class II | 1 |
| 18 Jul 2024 | Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India (94981) | Granules Consumer Health Inc. | Drug | Class III | 1 |
| 18 Jul 2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles. (94962) | MAIN PRODUCTS INC | Drug | Class I | 1 |
| 17 Jul 2024 | Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump | Baxter Healthcare Corporation | Device | Class II | 2 |
| 17 Jul 2024 | WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320 | Boston Scientific Neuromodulation Corporation | Device | Class II | 1 |
| 17 Jul 2024 | Kenny's Farmhouse Cheese - St. Jerome packaged in plastic vacuum sealed bags in 7oz wedges and whole 15lb wheels (95031) | Individual firm, name withheld | Food | Class I | 1 |
| 15 Jul 2024 | Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedure. Model… | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 1 |
| 15 Jul 2024 | Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A | Alcon Research LLC | Device | Class II | 36 |
| 15 Jul 2024 | Pariva Marinated Labneh Bites Za'atar; NET WT 8 OZ (225g); INGREDIENTS: YOGURT (CULTURED PASTEURIZED GRADE A MILK & CREAM, SKIM MILK, WHEY PROTEIN CONCENTRATE, SALT AND PECTIN), *SUNFLOWER OIL, *EXTRA VIRGIN OLIVE OIL, SESAME SEEDS, SPICES; CONTAINS: MILK, SESAME; Distributed by, Mayur, LLC, 196 Quincy St.,… | Pariva LLC | Food | Class II | 3 |
| 15 Jul 2024 | Nuts.com Ground Sumac 1 lb resealable stand-up pouches and 20 lb double lined plastic bags in a cardboard box. (94986) | Individual firm, name withheld | Food | Class II | 1 |
| 12 Jul 2024 | NavaClick Syringe and Needle, Model Number LIN02 (94963) | LINEAGE BIOMEDICAL, INC | Device | Class III | 1 |
| 12 Jul 2024 | RMU-2000 Automated Chest Compression Device | Defibtech, LLC | Device | Class I | 1 |
| 12 Jul 2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles. (94978) | SoloVital | Drug | Class I | 1 |
| 11 Jul 2024 | Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21. | Aurobindo Pharma USA Inc | Drug | Class I | 1 |
| 11 Jul 2024 | Elin Dessert Plates. The recalled plates are lilac in color with orange mushroom, moth, and fern motifs. The plates measure 21 cm (8.25 inches) in diameter and have scalloped edges. Plates sold individually in store. (94957) | Urban Outfitters Inc. | Food | Class II | 1 |
| 11 Jul 2024 | Bazzini Raw Almond Butter Net Wt. 16 oz (454g) UPC Code 7506284009. Packaged in clear plastic jars with plastic white lids. 12 jars per case | Bazzini LLC | Food | Class I | 1 |
| 11 Jul 2024 | Wiers Farm - Whole Salad Cucumbers bagged in 2lb plastic bags, 10 bags per carton | Wiers Farm Inc | Food | Class I | 27 |
| 11 Jul 2024 | Corey B's Oh Baby BBQ Sauce packaged in 12.6oz glass flask - 12 bottles per case (94984) | Hoff & Pepper, Co LLC. | Food | Class III | 1 |
| 11 Jul 2024 | Al'Fez Natural Tahini in 5.6oz glass jars, UPC 711464506778 (94980) | AB WORLD FOODS US INC | Food | Class I | 1 |
| 10 Jul 2024 | The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated for each analyte independently of the… | Ortho-Clinical Diagnostics, Inc. | Device | Class II | 1 |
| 10 Jul 2024 | IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation | Ion Beam Applications S.A. | Device | Class II | 1 |
| 10 Jul 2024 | DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. | Beckman Coulter Mishima K.K. | Device | Class II | 1 |
| 10 Jul 2024 | Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02. | Endo Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 9 Jul 2024 | McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only | Covidien | Device | Class I | 2 |
| 9 Jul 2024 | Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly | Covidien | Device | Class II | 1 |
| 9 Jul 2024 | TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery | Integra LifeSciences Corp. | Device | Class II | 1 |
| 9 Jul 2024 | BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900; | Becton Dickinson & Co. | Device | Class II | 1 |
| 9 Jul 2024 | Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. | DKK Dai-Ichi Shomei Co., Ltd. | Device | Class II | 4 |
| 9 Jul 2024 | All Natural KALO Chocolate Cake Gluten Free, UPC 8 53407 00418 4, Distributed by: Kalo Foods, LLC Stokesdale, NC 27357 (94961) | KALO Foods, LLC | Food | Class II | 1 |
| 9 Jul 2024 | Fox's u-bet Sugar-Free Chocolate Flavored Syrup, 18oz, UPC 070216246004, 12 retail units per wholesale case | SUBCO FOODS INC | Food | Class III | 2 |
| 8 Jul 2024 | GM60A. Digital Diagnostic Mobile X-Ray System. | NeuroLogica Corporation | Device | Class II | 1 |
| 8 Jul 2024 | Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01 | Hikma Pharmaceuticals USA Inc. | Drug | Class I | 1 |
| 8 Jul 2024 | Shelled Walnuts 1lb package in plastic flexible packaging. 24 packages per case (94991) | Stutz Packing Company | Food | Class I | 1 |
| 5 Jul 2024 | Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva. | DRG International, Inc. | Device | Class III | 1 |
| 5 Jul 2024 | Lunds & Byerlys pesto salmon and lemon rice. UPC 18169-66396. Net Wt. 12 oz. (340.2g). Keep Refrigerated. | Lunds Mitchell Rd LLC | Food | Class II | 1 |
| 3 Jul 2024 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25; | W.L. Gore & Associates, Inc. | Device | Class II | 1 |
| 3 Jul 2024 | VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 | Ortho-Clinical Diagnostics, Inc. | Device | Class II | 1 |
| 3 Jul 2024 | The recalled product is mis-labeled as Ancient Grain + Vegetable Salad item #25247. Product is perishable, refrigerated, and packaged in clear dome clamshell plastic container. Net weight approximately 2.6 pounds per package. Almond slices are visible through a clear plastic container. The label is read in parts… | Costco Wholesale Corporation | Food | Class I | 1 |
| 2 Jul 2024 | Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A | Stryker Sustainability Solutions | Device | Class II | 1 |
| 2 Jul 2024 | CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 00811400410 00811400420 00811400423 00811400426… | Zimmer, Inc. | Device | Class II | 1 |
| 2 Jul 2024 | Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472 | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 2 Jul 2024 | PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26. (94924) | Novel Laboratories, Inc. d.b.a Lupin Somerset | Drug | Class III | 1 |
| 2 Jul 2024 | Panaderia Guatemex - Sheca Redonda packaged in plastic bag | Individual firm, name withheld | Food | Class II | 15 |
| 1 Jul 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of compatible generators. The forceps' jaws… | Olympus Corporation of the Americas | Device | Class II | 3 |
| 1 Jul 2024 | Hill Country Fare Mustard Potato Salad refrigerated product is packaged in clear square plastic container with printed white plastic lid, net 48oz (3lb) 1.36 KG. UPC 4122003165. Distributed by H-E-B, San Antonio, TX 78204. There are 6 containers per case. | Reser's Fine Foods, Inc. | Food | Class II | 1 |
| 1 Jul 2024 | Raspberry Lemon Mixer is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening. | Urban River Spirits | Food | Class III | 24 |
| 1 Jul 2024 | Abby's Best BISCUIT MIX NET WEIGHT 4 LBS. 8 OZ. (2.04 KG) INGREDIENTS: ENRICHED BLEACHED FLOUR***PARTIALLY HYDROGENATED VEGETABLE SHORTENING (CONTAINS SOYBEAN OIL) WITH EMULSIFIER***LEAVENING***BUTTERMILK, SALT, SUGAR, CALSIUM CARBONATE PACKED FOR ABBY'S BEST BY ALFA MANUFACTURING CHARLESTON, SC 29406 (94911) | Alfa Supply, Inc. | Food | Class II | 1 |
| 28 Jun 2024 | Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300 | Baxter Healthcare Corporation | Device | Class II | 1 |
| 28 Jun 2024 | IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. | Philips North America Llc | Device | Class II | 4 |
| 27 Jun 2024 | Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD | Ventana Medical Systems, Inc. | Device | Class II | 1 |
| 27 Jun 2024 | Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E;… (94881) | Medivance Inc. | Device | Class II | 1 |
| 27 Jun 2024 | Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures. | Boston Scientific Corporation | Device | Class II | 2 |
| 27 Jun 2024 | Diamond Shruumz Infused Cones Cookies and Cream UPC 810133320025 | Prophet Premium Blends, LLC | Food | Class I | 22 |
| 27 Jun 2024 | Premo King Club Footlong 11.5oz, clear plastic, UPC 612510094259, 4 retail packages per wholesale case | Lipari Foods Operating Company, LLC. | Food | Class II | 3 |
| 26 Jun 2024 | BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or… | Becton Dickinson Infusion Therapy Systems, Inc. | Device | Class II | 1 |
| 26 Jun 2024 | Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90 (94884) | Individual firm, name withheld | Drug | Class III | 1 |
| 26 Jun 2024 | Bovine Collagen Peptide. Powder, Grade A, Cowhide Source. Net Weight: 20.0 kg. Made in China. (95117) | NANJING NUTRABUILDING BIO TECH C | Food | Class II | 1 |
| 25 Jun 2024 | Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm… | Preat Corp | Device | Class II | 1 |
| 25 Jun 2024 | HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System Controller, US, Model: 106531US; HeartMate 3… | Thoratec LLC | Device | Class II | 1 |
| 25 Jun 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India.… | Amerisource Health Services LLC | Drug | Class I | 1 |
| 24 Jun 2024 | BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9 | CareFusion 303, Inc. | Device | Class II | 19 |
| 24 Jun 2024 | Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, PURITAN BENNETT 560 VENTILATOR APAC/4096600-03, Puritan Bennett 560 Ventilator LATAM/4096600-04, Puritan Bennett 560… | Covidien | Device | Class I | 1 |
| 24 Jun 2024 | Orzo (vegan) Dried, net wt. 10oz in clear package with green/back printings on white label. UPC 810135110747. | PASTAURORA LLC | Food | Class II | 2 |
| 21 Jun 2024 | Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2 | A-S Medication Solutions LLC | Drug | Class I | 1 |
| 21 Jun 2024 | Foppen Smoked Norwegian Salmon Slices - Toast Size, packaged in 8.1oz vacuum foil, packaged within cardboard envelope. Keep Refrigerated at 38F or below. (94883) | Foppen Paling En Zalm B.V. | Food | Class I | 1 |
| 20 Jun 2024 | Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test | Luminex Corporation | Device | Class II | 1 |
| 20 Jun 2024 | Cepheid, Sample Collection Device, Part: 900-0370 | Cepheid | Device | Class II | 1 |
| 19 Jun 2024 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853 | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 18 Jun 2024 | SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702 | Angiodynamics, Inc. | Device | Class II | 2 |
| 17 Jun 2024 | Regard Kit containing the Microtek decanter | ROi CPS LLC | Device | Class II | 1 |
| 14 Jun 2024 | Alinity hq Analyzer, REF: 09P68-01 | Abbott Laboratories | Device | Class II | 1 |
| 14 Jun 2024 | Discrete photometric chemistry analyzer for clinical use. | Beckman Coulter, Inc. | Device | Class II | 1 |
| 14 Jun 2024 | Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 | Baxter Healthcare Corporation | Device | Class II | 1 |
| 14 Jun 2024 | L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539 | Argon Medical Devices, Inc | Device | Class II | 1 |
| 14 Jun 2024 | SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System | GE Medical Systems, LLC | Device | Class II | 26 |
| 13 Jun 2024 | Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level… | Steris Corporation | Device | Class II | 4 |
| 13 Jun 2024 | Friendly's Celebration Ice Cream Cake 60 fl oz, UPC 29839000920. Packaged in cardboard box, 4 boxes per case | Totally Cool, Inc. | Food | Class I | 68 |
| 12 Jun 2024 | SAVPAK Duro 10x10, 8oz plastic bag, DISTRIBUTED BY: Southcoast Product Inc. Dallas, Texas 75215; UPC 29661 00076. | Rancho Santo Cristo, Inc | Food | Class I | 2 |
| 11 Jun 2024 | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities,… | Merit Medical Systems, Inc. | Device | Class II | 23 |
| 10 Jun 2024 | BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 | BioFire Diagnostics, LLC | Device | Class II | 2 |
| 5 Jun 2024 | DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. | Beckman Coulter Mishima K.K. | Device | Class II | 1 |
| 3 Jun 2024 | C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs). | Microtek Medical Inc. | Device | Class II | 5 |
| 31 May 2024 | Soltive Premium SuperPulsed Laser System, Model TFL-PLS | Olympus Corporation of the Americas | Device | Class II | 3 |
| 31 May 2024 | NaturesPlus ULTRA T-MALE Maximum Strength Testosterone Boost for Men 60 Bi-layer Tablets | Natural Organics, Inc. | Food | Class III | 2 |
| 28 May 2024 | CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology. | Artivion, Inc | Device | Class II | 2 |
| 22 May 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. | Beckman Coulter, Inc. | Device | Class II | 1 |
| 21 May 2024 | Shahzada brand Pulses and Spices; Cinnamon Powder; 7 oz (200g); packaged in clear plastic zip-top bags (95044) | Advance Food International Inc. | Food | Class II | 1 |
| 16 May 2024 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿… | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 10 May 2024 | Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station. | LEICA BIOSYSTEMS NUSSLOCH GMBH | Device | Class II | 1 |
| 7 May 2024 | Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Infusion System, PLUM 360, PLUM 360"… | ICU Medical Inc | Device | Class I | 3 |
| 6 May 2024 | American Contract Systems Hand Pack convenience kit | American Contract Systems, Inc. | Device | Class II | 8 |
| 3 May 2024 | 1. Palmer Zebra Fudge Cookies, Enrobed Chocolatey Sandwich Cookies, Net Wt. 7 oz, UPC 77232 37064, distributed in case labeled Chocolate & Frosted Cookies, 16/7oz tubs/case. | Palmer & Company | Food | Class I | 18 |
| 18 Apr 2024 | 1- Name: Carbon Steel Utility Kitchen Knife Model: CSK1700 Size: Total length: 10.25" Type of packaging: Each knife packed in a single box 2- Name: Carbon Steel Utility Kitchen Cleaver Knife Model: CSK1701 Size: Total length: 10.5" Type of packaging: Each knife packed in a single box 3- Name: Carbon Steel Utility… (94800) | Individual firm, name withheld | Food | Class II | 1 |
| 8 Apr 2024 | Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 2 |
| 8 Apr 2024 | Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040; 6) UNIVERSAL BLOCK… | MEDLINE INDUSTRIES, LP - Northfield | Device | Class I | 3 |
| 22 Mar 2024 | LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 21 |
| 27 Feb 2024 | CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion,… | Smiths Medical ASD Inc. | Device | Class I | 3 |
| 8 Feb 2024 | Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire (94929) | EYE COMFORT CARE LLC | Device | Class II | 1 |
| 25 Jan 2024 | L&B Beautiful Morning Glory Muffins. Product #49025. 4 muffins per container. Net Wt 14 oz. UPC 18169-49025. | Lunds Mitchell Rd LLC | Food | Class II | 1 |
| 4 Dec 2023 | Lunds & Byerlys grilled chicken caesar salad, Net Wt: 9.0 oz. (255.2g) UPC 0 18169-66428 5. Lunds & Byerlys, Edina, MN 55424 | Lunds Mitchell Rd LLC | Food | Class II | 1 |
| 28 Oct 2021 | Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals. (95017) | Palodex Group Oy | Device | Class II | 1 |