| 14 Jul 2022 | Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd. for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-341-35. | CIPLA | Drug | Class II | 1 |
| 7 Jul 2022 | Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 | Apotex Corp. | Drug | Class II | 1 |
| 7 Jul 2022 | Lemon Muffins, item # 802387, are packaged in paper tray and covered with plastic film shrink wrap. Each tray contains 6 pieces and there are 6 trays per master case. PSB (Portland Specialty Baking) master case label is read in parts: "***PSB***LEMON MUFFINS *** 802387***6/36 OZ 6CT. TRAYS***". (90582) | Portland Specialty Baking LLC | Food | Class II | 1 |
| 6 Jul 2022 | Item 38180-12, Chuckanut Bay Cheesecake Bites New York + Chocolate. Perishable - Keep Refrigerated. There are 8 pieces per plastic clamshell pack and 12 packs per case. Net wt. per pack 6.4 oz. UPC 6 03812 38180 2. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, CHOCOLATE COMPOUND (sunflower… | Chuckanut Bay Foods LLC | Food | Class II | 15 |
| 3 Jul 2022 | Natreve Vegan Protein Powder 10 servings, 13.1oz (371g), UPC 628831120003 18 servings, 1.47lbs/23.53oz (667g), UPC 628831110073 (90561) | ARBORYPHARM FOODS INC. | Food | Class I | 1 |
| 30 Jun 2022 | Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10 | Nephron Sterile Compounding Center LLC | Drug | Class II | 37 |
| 29 Jun 2022 | SX-One MicroKnife (90520) | SONEX HEALTH LLC | Device | Class II | 1 |
| 29 Jun 2022 | ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525 | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 29 Jun 2022 | Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-405-60. | Glenmark Pharmaceuticals Inc., USA | Drug | Class III | 1 |
| 29 Jun 2022 | Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01 | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 28 Jun 2022 | Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-43 UPC 3 21130-78060 1 Distributed By Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566-0009; b) Solimo UPC 8 42379 14781 4 Distributed By: Amazon.com Services, Inc. Seattle, WA 98109; c) QC… | Vi-Jon, LLC | Drug | Class II | 1 |
| 27 Jun 2022 | (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 27 Jun 2022 | Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375. | Individual firm, name withheld | Drug | Class I | 6 |
| 24 Jun 2022 | SIGNA Premier magnetic resonance scanner, model 5748519. | GE Healthcare, LLC | Device | Class II | 1 |
| 24 Jun 2022 | LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip | LumiraDx | Device | Class II | 2 |
| 24 Jun 2022 | Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress. | Baxter Healthcare Corporation | Device | Class II | 7 |
| 24 Jun 2022 | Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 59779-871-45, UPC 0-50428-40950-3 | Vi-Jon, LLC | Drug | Class II | 1 |
| 24 Jun 2022 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5552-3 | Noven Pharmaceuticals Inc | Drug | Class II | 1 |
| 24 Jun 2022 | Organic Oregano Ground is packed in bulk 35 lbs. cases with food-grade poly bag that is labeled in parts: "OREGONSPICE COMPANY***OG Oregano Ground***Net Wt 35 lb (15.89 kg)***13320 NE Jarrett St.*Portland, Oregon 97230***". (90510) | OS Holding Inc | Food | Class I | 1 |
| 23 Jun 2022 | Pure Ground Ingredients Organic Oregano Leaf Powder Item#: OREO-PW Weight: 35 LBS/15.89 kgs Processed and Packaged at Pure Ground Ingredients 2535 Business Parkway Minden, NV 89423 Certified Organics By CCOF Organic Oregano Leaf Ground Item#: OREO-GR Weight: 35 LBS/15.89 kgs Processed and Packaged at Pure Ground… (90513) | Individual firm, name withheld | Food | Class I | 1 |
| 23 Jun 2022 | Slap Ya Mama Louisiana Food Products Slap Ya Mama Cajun Fish Fry packaged in a 5.5lb plastic container with plastic screw top - 4 units per case UPC 8 17885 00027 4 (90515) | Walker & Sons Inc | Food | Class II | 1 |
| 22 Jun 2022 | Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0 | Randox Laboratories Ltd. | Device | Class II | 1 |
| 22 Jun 2022 | Panera Bread at Home Southwest Corn Chowder, 16 oz. (453 g) | Blount Fine Foods Corporation | Food | Class I | 1 |
| 22 Jun 2022 | Targil's Hot Tails Louisiana Crawfish House Chicken Breading packaged in 25lb boxes | Belmatt Inc Aka Targill Seasonings | Food | Class II | 4 |
| 21 Jun 2022 | Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol- Baroda Highway, Halol-Baroda, Highway, Halol- 389 350, Gujarat, India, NDC 62756-015-40. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 21 Jun 2022 | Blue Kuna Taste of Devil's Night Heat Infused BBQ Sauce, 16 oz (90497) | Food Entrepreneur Accelerator and Startup Terminal, DBA FEAST Detroit | Food | Class II | 1 |
| 21 Jun 2022 | 9-inch pie Blazos Pie Shoppe Chocolate Peanut Butter Cream Pie (UPC 9438600049) 9-inch pie Blazos Pie Shoppe Peanut Butter Cream Pie (UPC 9438600025) | Tarts A La Carte, LLC dba Blazo Pie shoppe LLC | Food | Class I | 2 |
| 21 Jun 2022 | SoDelicious DairyFree Wondermilk Dairy Free Frozen Dessert Salted Caramel Sundae, 3 - 4 fl oz (12 fl oz) cones per carton. UPC 0 36632 07821 6 Manufactured by/for: So Delicious Dairy Free, Eugene, OR 97402. Keep frozen. | DANONE US LLC | Food | Class II | 1 |
| 19 Jun 2022 | GOODMAN GLUTEN FREE; Vegan Apple Pie, Fully Baked 16.4 oz, paperboard box; INGREDIENTS: Apples, Potato Starch, Palm Oil, Sugar, Brown Rice Flour, White Rice Flour, Dextrose, Xanthan Gum, Salt. Processed in a facility that also processes: Egg, Tree Nuts; Manufactured for GOODMAN FOOD PRODUCTS, LLC MADISON, CT 06443 (90496) | Goodman Food Products LLC | Food | Class III | 1 |
| 18 Jun 2022 | 50# (pound) Domino Light Brown Sugar. This is packaged in bags made of multiple ply kraft paper, and a poly liner. product number is 403350 | Domino Foods Inc | Food | Class II | 1 |
| 17 Jun 2022 | Verigene CDF Nucleic Acid Test, Part No. 30-002-22 | Luminex Corporation | Device | Class II | 2 |
| 17 Jun 2022 | Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., New Brunswick NJ 08901 USA; Relabeled by: Bryant Ranch Prepack, Inc., Burbank, CA, 91504 USA, NDC: 63629-1088-01. | Bryant Ranch Prepack, Inc. | Drug | Class I | 2 |
| 16 Jun 2022 | Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430. | Glenmark Pharmaceuticals Inc., USA | Drug | Class III | 1 |
| 16 Jun 2022 | Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30. | Jubilant Draximage Inc | Drug | Class II | 1 |
| 16 Jun 2022 | Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07 | Macleods Pharma Usa Inc | Drug | Class II | 1 |
| 16 Jun 2022 | Favorite Day Lavender Shortbread Cookie Bites Net Wt 7oz (198g) packaged in a purple bag and an inside silver flexible bag UPC 085239286098, 6 units per case (90461) | J & M Foods, Inc. | Food | Class I | 1 |
| 15 Jun 2022 | SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 15 Jun 2022 | Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561 | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 15 Jun 2022 | Plant Based Yogurt Culina Blueberry Lavender Nt Wt 5 oz. (142 g) UPC 854724007117 packaged in glass container 12 jars per case | EAT REAL FOOD LLC | Food | Class II | 6 |
| 15 Jun 2022 | AloePro Dietary Supplement Made With Organic ALOE VERA LIQUID 16 FL Oz. (475 mL) PREMIER RESEARCH LABS UPC Code: 80773500137 packaged in plastic HDPW bottles (90491) | Premier Research Labs LLC | Food | Class II | 1 |
| 14 Jun 2022 | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095 | R & D Systems, Inc. | Device | Class III | 1 |
| 14 Jun 2022 | Wright EVOLVE TRIAD Plate Cutter, REF 49510120 | Wright Medical Technology, Inc. | Device | Class II | 1 |
| 13 Jun 2022 | LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 | CooperSurgical, Inc. | Device | Class II | 1 |
| 13 Jun 2022 | Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments. | K2M, Inc. | Device | Class II | 1 |
| 13 Jun 2022 | Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16 | Akorn, Inc. | Drug | Class II | 1 |
| 13 Jun 2022 | CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 30594 2. | Vi-Jon, LLC | Drug | Class I | 1 |
| 11 Jun 2022 | Revie Superfoods Berry Blu 194g Ready-to-Blend Blueberry Creamsicle Smoothie Made in Canada UPC 8 54681 00005 3 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada | Revive Organics, Inc. | Food | Class II | 7 |
| 10 Jun 2022 | Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 10 Jun 2022 | Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model) | Invacare Corporation | Device | Class III | 1 |
| 10 Jun 2022 | RayStation 11B | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 10 Jun 2022 | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 | Macleods Pharma Usa Inc | Drug | Class II | 1 |
| 10 Jun 2022 | Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por: "PLANTAS MEDICINALES DE MEXICO", Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800 Mexico, UPC 7 501031 111138 (90427) | Latin Foods Market | Drug | Class I | 1 |
| 10 Jun 2022 | Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1, Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085 | Wedgewood Village Pharmacy, LLC | Drug | Class II | 6 |
| 10 Jun 2022 | Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02 | Akorn, Inc. | Drug | Class II | 1 |
| 10 Jun 2022 | PurAqua Belle Vie SPARKLING WATER wellness RELAX 100mg ASHWAGANDHA PER 12 FL OZ STRAWBERRY CUCUMBER FLAVORED SPARKLING WATER WITH OTHER NATURAL FLAVORS 12 FL OZ (355mL) CAN UPC: 4099100315622 (90418) | Independent Beverage Company LLC | Food | Class II | 1 |
| 9 Jun 2022 | Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation. | Abbott | Device | Class II | 1 |
| 9 Jun 2022 | Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD | Randox Laboratories Ltd. | Device | Class III | 2 |
| 9 Jun 2022 | Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR… | Alcon Research, LLC | Device | Class II | 1 |
| 9 Jun 2022 | CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 | Zeltiq Aesthetics, Inc | Device | Class II | 5 |
| 9 Jun 2022 | SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 29101 3 (90384) | Green Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 8 Jun 2022 | GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation. | GE Healthcare, LLC | Device | Class II | 1 |
| 8 Jun 2022 | Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion. | Covidien Llc | Device | Class I | 9 |
| 8 Jun 2022 | Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ (10 mL) tubes, UPC Code 860002022116 (90382) | Buzzagogo, LLC | Drug | Class I | 1 |
| 8 Jun 2022 | Built Bar, Banana Cream Pie Puffs Protein Bar, 1.41 oz. (40 g) net wt., packaged in individual wrapper, Built Brands, LLC, 600 E Quality Dr., American Fork, UT 84003. SKU 30000318. Product sold as part of a paperboard 12-count mixed box. Each box contains 4 affected bars. UPC 8 40229 30053 2. Product is intended for… (90428) | BUILT BRANDS LLC | Food | Class I | 1 |
| 7 Jun 2022 | HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880 | Davol, Inc. | Device | Class II | 2 |
| 7 Jun 2022 | Wawa COLD BREW COFFEE***ONE PINT (473ML)***MADE WITH WAWA COLD BREW***Nutrition Facts***INGREDIENTS: CREAM, SKIM MILK, LIQUID SUGAR (SUGAR, WATER), CORN SYRUP, WHEY, COFFEE, GUAR GUM, LOCUST BEAN GUM, TARA GUM, CARAMEL COLOR CONTAINS: MILK*DISTRIBUTED BY WAWA, INC, WAWA, PA 19063 (90413) | Royal Ice Cream Company | Food | Class I | 1 |
| 6 Jun 2022 | Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC… | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 3 |
| 3 Jun 2022 | Hobbs Medical Polypectomy Snare, Catalog No. 7202 | Hobbs Medical, Inc. | Device | Class II | 1 |
| 3 Jun 2022 | Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, REF: SFP914170 TREVO NXT 6X37+TRAK21+CAT6 3-PACK… (90482) | Individual firm, name withheld | Device | Class II | 1 |
| 3 Jun 2022 | Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000 | Ambu Inc. | Device | Class II | 1 |
| 3 Jun 2022 | Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV. | ROi CPS LLC | Device | Class II | 2 |
| 3 Jun 2022 | Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 3 Jun 2022 | Prairie City Bakery Peanut Butter Chocolate Chip Ooey Gooey Butter Cake 2oz. individual UPC: 7-9788436718-2; 10 individual units per display unit; 6 display units per wholesale case. (90416) | Prairie City Bakery | Food | Class I | 1 |
| 3 Jun 2022 | Bix Produce Diced Spinach, Item # 15939. packaged in 2lb bags, with 5 bags per case | Bix Produce Company LLC | Food | Class II | 1 |
| 3 Jun 2022 | Boar's Head Brand Spinach Greek Yogurt Dip. packaged in plastic container with lid. Net Wt. 12oz. UPC 42421-16282. Keep Refrigerated. Distributed by: Brunckhorst Co., NY, NY 11206-3886. (90380) | Klondike Cheese Company | Food | Class II | 1 |
| 3 Jun 2022 | 1st Phorm High Quality Protein Level-1 Bar Chocolate Crunch Protein Bars. 15 Bars Per Box. Net Wt. 12-2.22oz (63g) Bars 33.3oz (945g) Per Box. UPC: 5002619600 (90540) | Bakery Barn, LLC | Food | Class II | 1 |
| 2 Jun 2022 | YelloPort Elite Universal Seal. For use in laparoscopic procedures. | Surgical Innovations Ltd | Device | Class II | 1 |
| 2 Jun 2022 | DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius. (90421) | CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. | Device | Class II | 1 |
| 2 Jun 2022 | Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier | Breas Medical, Inc. | Device | Class II | 1 |
| 2 Jun 2022 | Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System. | Wright Medical Technology, Inc. | Device | Class II | 1 |
| 2 Jun 2022 | Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A | Skytron, Div. The KMW Group, Inc | Device | Class II | 1 |
| 2 Jun 2022 | Wilton Rainbow Sprinkles Mix net wt 5.92 oz. item number 710-0-0627 | Wilton Industries Inc | Food | Class II | 2 |
| 1 Jun 2022 | GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000. | GE Healthcare, LLC | Device | Class I | 1 |
| 1 Jun 2022 | NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 1 Jun 2022 | RayStation 9B SP1. For radiation treatment planning. | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 1 Jun 2022 | Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures. | Ultradent Products, Inc. | Device | Class II | 1 |
| 1 Jun 2022 | epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515 | Siemens Healthcare Diagnostics Inc | Device | Class II | 1 |
| 1 Jun 2022 | Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM | Spectranetics Corporation | Device | Class II | 1 |
| 1 Jun 2022 | Ventana HE 600 System, automated slide preparer, for use in laboratories. | Ventana Medical Systems Inc | Device | Class II | 1 |
| 31 May 2022 | NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent… (90386) | Synapse Biomedical Inc | Device | Class III | 1 |
| 31 May 2022 | GreenLight HPSEA Laser Fibers, UPN 0010-2092 | Boston Scientific Corporation | Device | Class III | 1 |
| 31 May 2022 | NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0 | Fresenius Medical Care Holdings, Inc. | Device | Class II | 2 |
| 31 May 2022 | NaviCare Nurse Call/Voalte Nurse Call | Baxter Healthcare Corporation | Device | Class II | 1 |
| 30 May 2022 | OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents. (90312) | Individual firm, name withheld | Device | Class II | 1 |
| 27 May 2022 | GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000. | GE Healthcare, LLC | Device | Class II | 1 |
| 26 May 2022 | SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX550S (Carton) - 550 Micron Single Use… | Olympus Corporation of the Americas | Device | Class II | 1 |
| 26 May 2022 | Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960 | Ortho-Clinical Diagnostics, Inc. | Device | Class II | 1 |
| 26 May 2022 | Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B092P4615M, UPC 7 501031 111190 | Amazon.com, Inc. | Drug | Class I | 3 |
| 26 May 2022 | Nature s Promise Organic Mango, Banana, Kale, Rice & Pineapple Baby Food, 3.5 oz (99 g), Pouch, Case pack of 12 (12 inners of 6 each). Store in a dry ventilated area. Do not expose to sunlight. Do not microwave. After opening, store in refrigerator a maximum of 48 hours. Shake well before opening. (90388) | Fruselva America SPA | Food | Class II | 1 |
| 25 May 2022 | Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838 | Cook Incorporated | Device | Class II | 1 |
| 25 May 2022 | The content inside package is walnut but was mis-labeled as Nutritional Yeast and packaged in a stand up plastic pouch. Net Weight: 0.6lb (272g). UPC: 616316762060 The label is read in parts: "***Brand Name: Hummingbird ***Organic Nutritional Yeast Large Flake***". | Honey Heaven Wholesale Inc | Food | Class II | 1 |
| 24 May 2022 | Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 24 May 2022 | Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis. | Waldemar Link GmbH & Co. KG (Mfg Site) | Device | Class II | 4 |
| 24 May 2022 | WIEBE DAIRY RAW MILK CHEESE Ingredients: Grade A Raw milk, salt, cheese culture, enzyme, annatto Cottonwood River RESERVE www.jasonwiebedairy.com Durham, KS 67438 Plant # 20-037 Carton Label (not available to consumers) ITEM ID: 02000002 PARIS BROTHERS, INC. 8800 NE UNDERGROUND DR KANSAS CITY, MO 64161 (816) 455-4188… | Paris Brothers Inc | Food | Class II | 8 |
| 24 May 2022 | PEANUT BUTTER CHOCOLATE FUDGE BAR - 8 oz. | Fudgeamentals LLC | Food | Class I | 7 |
| 23 May 2022 | MiniMed 620G Insulin Pump (O.U.S. version) | Individual firm, name withheld | Device | Class II | 8 |
| 23 May 2022 | Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01 (90245) | Akcea Therapeutics, Inc. | Drug | Class I | 1 |
| 23 May 2022 | GE Bakery, Cookie, Thumbprint, Peanut Butter, 12 Oz., Clam Shell | Individual firm, name withheld | Food | Class I | 11 |
| 23 May 2022 | Quick Chek, #14294 Apples and Peanut Butter Snack Tray, each case is 12/ 5.1 oz. Plastic Tray with lid, 12 packages per case, Keep refrigerated. | Safeway Fresh Foods LLC | Food | Class I | 1 |
| 22 May 2022 | Snack Fresh Apples and Peanut Butter Net Wt 6.5 oz. packed in clear plastic non-flexible package UPC 0 74641 00044 6 six count per case | Stellex/CF Houston, LLC | Food | Class I | 5 |
| 21 May 2022 | Wawa Apples & Peanut Butter dipper 4.9oz. snack plastic cups | Taylor Farms Florida, Inc. | Food | Class I | 1 |
| 20 May 2022 | CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001 (90417) | Individual firm, name withheld | Device | Class II | 1 |
| 20 May 2022 | EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI8060L | DePuy Spine, Inc. | Device | Class II | 2 |
| 20 May 2022 | Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 20 May 2022 | regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile. | ROi CPS LLC | Device | Class II | 1 |
| 20 May 2022 | PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX. | Cordis US Corp | Device | Class II | 1 |
| 20 May 2022 | Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512 | Agilent Technologies, Inc. | Device | Class III | 1 |
| 20 May 2022 | Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system | Draeger Medical Systems, Inc. | Device | Class II | 1 |
| 19 May 2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I | Chromsystems Instruments & Chemicals GmbH | Device | Class II | 2 |
| 19 May 2022 | Sensica Urine Output System | C.R. Bard Inc | Device | Class II | 1 |
| 18 May 2022 | Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 18 May 2022 | ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 | Radiometer Medical ApS | Device | Class II | 1 |
| 18 May 2022 | MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000, 136358000, 136360000 | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 17 May 2022 | #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED | Baxter Healthcare Corporation | Device | Class II | 1 |
| 13 May 2022 | RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D. (90301) | Rayner Intraocular Lenses Ltd | Device | Class II | 1 |
| 13 May 2022 | EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535. | Covidien, LP | Device | Class II | 1 |
| 13 May 2022 | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797 | Volcano Corp | Device | Class III | 2 |
| 13 May 2022 | Market Day Krabbycakes, Item 3320, Net Wt. 40 oz. (2.5 lbs.) 1.13kg. Item Number 803320R. UPC 51497 14360. Light panko Breadcrumbs blended with Snow Crab meat, Fresh Cream & Real Butter with Seasonings. Keep Frozen - Fully Cooked. Distributed & Sold exclusively by: Market Day Local, Inc. Whitefish, MT 59937 (90193) | Market Day Local Inc. | Food | Class II | 1 |
| 11 May 2022 | Medline Pill Splitters; 1 each/box; 144 boxes/carton | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 11 May 2022 | Kristi's Key Lime Cookies, A Florida Original (90249) | Individual firm, name withheld | Food | Class II | 1 |
| 9 May 2022 | BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US) | Becton Dickinson & Company | Device | Class II | 11 |
| 6 May 2022 | VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF ARDVST229037A VST66DF | Getinge Usa Sales Inc | Device | Class II | 1 |
| 5 May 2022 | Arrow Three-Lumen CVC | ARROW INTERNATIONAL Inc. | Device | Class II | 1 |
| 4 May 2022 | Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 3 May 2022 | System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW | Canon Medical System, USA, INC. | Device | Class II | 1 |
| 2 May 2022 | Clean Catch Urine Kit NS 178489, AHMU58A | American Contract Systems, Inc. | Device | Class I | 2 |
| 28 Apr 2022 | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) | Isopure Corp | Device | Class II | 1 |
| 28 Apr 2022 | Almond Coconut Classic Truffle. Net Wt. 1.4 oz. PLU Code: 788394 11025 2. Ingredients: Milk & dark chocolate, honey, butter (pasteurized cream & salt), cream, coconut, almonds, non-fat dry milk, whey, natural flavors, agar, algin & lecithin. Note: Typo on website should be algin. | Queen Bee Gardens, LLC | Food | Class II | 49 |
| 27 Apr 2022 | X80 RADiant Photoelectric Therapy System | Xstrahl Limited | Device | Class II | 1 |
| 26 Apr 2022 | TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 | Haemonetics Corporation | Device | Class II | 1 |
| 25 Apr 2022 | Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019 | GE Healthcare, LLC | Device | Class II | 2 |
| 22 Apr 2022 | Ivenix Infusion System (IIS) (90314) | Ivenix, Inc. | Device | Class II | 1 |
| 21 Apr 2022 | ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier (90165) | Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) | Device | Class II | 1 |
| 21 Apr 2022 | Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028 | Atrium Medical Corporation | Device | Class II | 1 |
| 19 Apr 2022 | Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG… | Haemonetics Corporation | Device | Class II | 1 |
| 16 Mar 2022 | Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA. | Golden State Medical Supply Inc. | Drug | Class II | 4 |
| 7 Mar 2022 | Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding | TMC Acquisition LLC dba Tailor Made Compounding | Drug | Class II | 52 |
| 25 Feb 2022 | syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 20 Jan 2022 | QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3 | Microgenics Corporation | Device | Class II | 1 |
| 25 Oct 2021 | MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441 | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 7 Oct 2021 | ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605 (90281) | Individual firm, name withheld | Device | Class II | 1 |
| 3 Aug 2021 | AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US) | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 30 Jun 2021 | RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. | Aesculap Implant Systems LLC | Device | Class II | 2 |
| 19 May 2021 | ProxiDiagnost N90. radiography and fluoroscopy system | Philips Medical Systems DMC GmbH | Device | Class II | 5 |
| 5 May 2021 | Omnera 400T Digital Radiographic System | Arcoma AB | Device | Class II | 2 |
| 19 Feb 2021 | Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010 | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 5 Jan 2021 | HAMILTON-H900 Humidifier, Models: 950001, 950004 | Hamilton Medical AG | Device | Class III | 1 |
| 18 Nov 2020 | ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 8 Sep 2020 | AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery. | Aesculap Implant Systems LLC | Device | Class II | 6 |
| 13 Jul 2020 | ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 22 Jan 2020 | Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 12 Nov 2019 | ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery. | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 1 Oct 2019 | Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R. | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 25 Sep 2019 | AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 4 Dec 2018 | Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 | Stryker Instruments Div. of Stryker Corporation | Device | Class III | 1 |