| 17 Jun 2021 | Tight! Xtreme Reloaded: 120 count capsules (serving size 3 capsules) Ingredients: Evapor8 Total Body Fat Assault Matrix (Sulbutiamine, Caffeine Anhydrous, Beta-Phenethylamine, Hordeum Vulgare [Root] [Std. to 98% Hordenine], FucoPure [10% Fucoxanthin], Peganum Hamala Extract, Fursultiamine, Citrus Reticulata Extract… Event 88121 | SAN Corporation | Food | Class II | 1 |
| 14 Jun 2021 | Designed by Nature Cow's Milk Formula: 12 oz. plastic pouch. Easy to Digest, Nutritionally Alive, Developed for All Life Stages. For the Little Ones in Your Life. UPC: 0 19962 28421 2 | Designed by Nature LLC | Food | Class I | 3 |
| 14 Jun 2021 | Ful-Flav-R Green Pace Chili Diced 3/8" w Citric Acid; Item # 544-107-7 Net Weight 400 lbs. (181.436 KG) Refrigerate after opening. Ingredient: Green Pace Peppers & citric Acid. Ful-Flav-R Products, a Division of Pacific Farms, Oakland, CA 94621 Event 88124 | Pacific Meridian Group, LLC | Food | Class II | 1 |
| 11 Jun 2021 | Bulk Salted Butter, item #502. Butter solid block is packaged in carton case with plastic liner, net wt. 55 lb. (25kg). The label is read in parts: "***BUTTER 55.115 LBS. NET (25 KG) ***PLANT NO. 41-41***". Event 88118 | Larsen's Creamery, Inc. | Food | Class II | 1 |
| 9 Jun 2021 | Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13 | AVKARE Inc. | Drug | Class III | 1 |
| 9 Jun 2021 | QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou Event 88070 | World Source Llc | Drug | Class II | 1 |
| 9 Jun 2021 | Su Cocina Pan Molido bread crumbs in 8 oz. packages. UPC 6 79790 05912 5. The label of 8 oz. package is read in parts: "***Plain Bread Crumbs *** Su Cocina Pan Molido***INGREDIENTS: Enriched wheat Flour ***Corn Starch, Corn Syrup, Water, Contains 2% or less of the following: Soybean Oil and/or Canola Oil, Salt,… Event 88092 | Dominguez Foods of Washington, Inc. | Food | Class II | 1 |
| 8 Jun 2021 | Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05. | Bausch Health Companies, Inc. | Drug | Class III | 2 |
| 8 Jun 2021 | Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite 2 Simpsonville, SC 29681. NDC: 73463-0100-01 Event 88097 | Prisma Health Outsourcing Facility | Drug | Class III | 1 |
| 7 Jun 2021 | reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment. | Pear Therapeutics, Inc. | Device | Class II | 2 |
| 4 Jun 2021 | Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05. Event 88041 | Name withheld | Drug | Class III | 1 |
| 4 Jun 2021 | Olde Thompson Organic Ground Coriander 1.5oz. in glass jar with flip-top lid. Sun Harvest Organic Coriander 1.5oz in glass jar with flip-top lid. UPC code: 400000290942 Olde Thompson item numbers: 1901-43, 1901-43CA, 1901-43SU Event 88060 | Olde Thompson, LLC | Food | Class I | 1 |
| 2 Jun 2021 | O'Brien's Own Gourmet Granola, blueberry muffin, Net Wt. 12 OZ , UPC 6 09132 49665 3, Manufactured and Distributed by O'Brien's Own Gourmet Granola, Center Point, IA. | Browns Granola Company, LLC | Food | Class II | 3 |
| 2 Jun 2021 | Hix Sauces, Buffalo Wing Sauce, Original Spice, Net Wt. 12.5 oz (355g) Event 88030 | Hix Foods, Inc. | Food | Class II | 1 |
| 2 Jun 2021 | Brown Rice Quinoa Farro, Fully Cooked Net Wt. 24 lbs, Item # 617322 | Savor Brands LLC. | Food | Class I | 2 |
| 1 Jun 2021 | OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101 Event 88075 | Name withheld | Device | Class II | 1 |
| 1 Jun 2021 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01 | VIONA PHARMACEUTICALS INC | Drug | Class II | 1 |
| 1 Jun 2021 | Adobo para Chorizo - Chorizo Marinade - Seasoning for Sausage. Product is packaged in a plastic bucket seal with lid, 5 gallons. No UPC. The label is read in parts: "*** Adobo para Chorizo *** Seasoning for Sausage *** Ingredients: Dried Chilies, vinegar, almonds, salt, pepper, garlic, cumin, clove, oregano, mint,… Event 88039 | Jesmar Spices, LLC | Food | Class II | 1 |
| 1 Jun 2021 | a.) Banner Smoked Fish Inc. brand Sliced Smoked Scotch Style Salmon (Salmon, Salt, Sugar, Natural Wood Smoke, Sodium Nitrite) b.) Banner Smoked Fish Inc. brand Naturally Smoked Nova Salmon Bagel Cuts (Salmon, Salt, Sugar, Sodium Nitrite, Natural Hardwood Smoke) c.) Westside Market NYC brand Naturally Smoked Nova… | Banner Smoked Fish Inc. | Food | Class I | 36 |
| 28 May 2021 | Enoki Mushroom, 150g clear plastic bag with orange bottom; UPC 085412004020 Product of Korea Do no consume Raw Distributed by Rainfield Marketing Group Event 88015 | RAINFIELD MARKETING GROUP | Food | Class I | 1 |
| 28 May 2021 | Concord Farms Fresh Enoki Mushrooms; 5.25 oz. (150g) or 7 oz. (200g) packages UPC: 049995041049 and 04999504103 US Distributor: Concord Farms, Vernon, CA All Natural, Product of Korea Keep Refrigerated. Rinse and Cook before eating. Event 88017 | Concord Farms | Food | Class I | 1 |
| 28 May 2021 | Seafood Mushroom Keep Refrigerated Net Wt. 5.3 oz./150g Distributed By: Sun Hong Foods, Inc. Montebello, CA 90640 Packaged in clear plastic with green bottom Event 88027 | Sun Hong Foods, Inc. | Food | Class I | 1 |
| 28 May 2021 | Good & Gather Sweet Cajun Trail Mix, Product Number 04659. with Butter Toffee Peanuts, Spicy Seasoned Peanuts, Cajun Sesame Sticks, Roasted Salted Corn Kernels & Honey Roasted Sesame Sticks. Net Wt 11 oz. (311g), UPC 85239-15700 | John B. Sanfilippo & Son Inc. | Food | Class II | 5 |
| 28 May 2021 | Glaceau Vitaminwater XXX labeled to be Glaceau Vitaminwater Zero Sugar XXX acai-blueberry-pomegranate, 16.9 FL OZ, made for glaceau, Atlanta, GA | The Coca-Cola Company | Food | Class II | 1 |
| 27 May 2021 | Tiger Nuts Flour - 2.2 lbs. (1 Kilo) boxes Event 88002 | Name withheld | Food | Class I | 1 |
| 26 May 2021 | Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India NDC 63739-795-10 Event 88008 | McKesson Corporation dba McKesson Drug Company | Drug | Class III | 1 |
| 26 May 2021 | ORGANIC GEMINI TigerNut Flour, Ingredients: 100% Organic Tiger Nuts; 27.5lbs; Lot: TM2-24200RFFF1; EXP: 10/2021 Event 88001 | HMO Beverage Corp. dba Organic Gemini LLC | Food | Class I | 1 |
| 25 May 2021 | Whole Foods Market Organic Dark Red Kidney Beans, Net Wt 15.5 oz. (439g) UPC 99482-45272. Distributed by: Whole Foods Market, Austin, TX 78703 | Faribault Foods, Inc. | Food | Class II | 1 |
| 25 May 2021 | Organic Microwave Butter Popcorn in cartons labeled to be Organic Microwave Popcorn Salted, Net Wt 8.7 OZ, Distributed by TOPCO Associates LLC Elk Grove, IL, UPC 0 36800 40611 7 | Gilster-Mary Lee Corp. | Food | Class I | 1 |
| 25 May 2021 | BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801 | Lopez Gonzalez Santana Corporation | Food | Class III | 2 |
| 24 May 2021 | Hy-Vee Chicken Street taco kit, Net Wt. 18 OZ, UPC 282503 212993. | Hy-Vee Stores Inc | Food | Class I | 1 |
| 24 May 2021 | Giant Eagle Chicken Street Taco Kit; 20 oz (1 lbs 4 oz) Individual Units, PLU Code beginning 256598 00000 | Giant Eagle, Inc. | Food | Class I | 1 |
| 22 May 2021 | Chicken Street Taco kit in a plastic tray with a clear plastic lid. | The Kroger Co | Food | Class I | 1 |
| 21 May 2021 | SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria. | Sunstar Americas, Inc. | Device | Class II | 1 |
| 21 May 2021 | DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20 | Hill Dermaceuticals, Inc. | Drug | Class II | 1 |
| 21 May 2021 | ***Chicken Street Taco Kit with Trays, item # 13454.38080, Refrigerated product, 2/4.985 lbs. kits in each case. Distributed by Reser's Fine Foods, Topeka, KS. ***Homechef Chicken Street Taco Kit with Trays, item # 40134.30435, Refrigerated product, 2/4.985 lbs. kits in each case. Distributed by Reser's Fine Foods,… | Reser's Fine Foods, Inc. | Food | Class I | 1 |
| 20 May 2021 | Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186. | Noven Pharmaceuticals Inc | Drug | Class II | 2 |
| 20 May 2021 | Lemon, Sage Parmesan & Romano Cream Sauce. The product is in a 12.6 oz. Mason glass jar, lid and ring, and tamper evident shrink wrapped. UPC 8 60001 31924 8. The label is read in parts: "*** LEMON SAGE PARMESAN & ROMANO CREAM SAUCE *** Ingredients: Heavy whipping cream, white wine, butter, shallot, garlic, fresh… Event 87988 | Kumpunny's LLC | Food | Class II | 1 |
| 19 May 2021 | LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 19 May 2021 | GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 | Vero Biotech, LLC | Device | Class I | 1 |
| 18 May 2021 | PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006 | Miracle 8989 | Drug | Class I | 3 |
| 18 May 2021 | Torn Ranch Organic Dark Chocolate Blueberries 18oz. resealable bags UPC: 036412020169 Item code: 2016-18-CW Produced by Torn Ranch Petaluma, CA 94954 Event 87970 | Torn Ranch LLC. | Food | Class I | 1 |
| 17 May 2021 | JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1 | Smiths Medical ASD Inc. | Device | Class I | 1 |
| 17 May 2021 | Mahayograj Guggulu; 120 Vegetarian Capsules, 1/2 lb. bags of powder Dietary Supplement, 1030 Matley Lane, Unit A Reno, NV 89502 Serving size: 2 capsule Servings per container: 60 Proprietary Blend - 500 mg Certified Organic Distributed by Garry N Sun USA Event 87946 | Garry N Sun USA Inc. | Food | Class I | 1 |
| 17 May 2021 | BulkFoods.com brand dehydrated chopped celery in 1lb and 5lb plastic bags | Natural Foods Inc | Food | Class I | 3 |
| 15 May 2021 | Clio Berry Acai flavored Less Sugar Yogurt Bar in a Chocolate Coating 45g x 10 Clio Retail 10-pack, UPC: 854021008244 | Clio LLC | Food | Class II | 16 |
| 15 May 2021 | Clio No Added Sugar Yogurt Bar Mixed Berry / Peach 50g x 16 (12pc tray). UPC Code: 854021008220 | Clio LLC | Food | Class II | 10 |
| 14 May 2021 | ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to… | Brainlab AG | Device | Class II | 1 |
| 14 May 2021 | DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 | DeRoyal Industries Inc | Device | Class I | 3 |
| 14 May 2021 | READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-244-01 | Medline Industries Inc | Drug | Class III | 1 |
| 14 May 2021 | Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310. | Teligent Pharma, Inc. | Drug | Class II | 1 |
| 14 May 2021 | BC Foods AD Celery Stalk Canners, 25 lb. Poly lined bulk fiber carton, item code VCES-TCA-BJA-AA-AB; BC Foods AD Celery Stalk Cross Cut, 25 lb. Poly lined bulk fiber carton, item code VCES-TC9-BQS-AC-AB; BC Foods AD Celery Stalk Cross Cut, 25 lb. Poly lined bulk fiber carton, item code VCES-TC9-BQS-AG-AB. | BCFoods, Inc. | Food | Class I | 2 |
| 13 May 2021 | Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111 NDC: 69423-903-41, UPC 0 37000 28803 9 Event 87944 | Accupac, Inc. | Drug | Class II | 1 |
| 12 May 2021 | Xtra Butter Microwave Popcorn bags packaged in cardboard boxes labeled to be Jolly Time Healthy Pop 100's Kettle Corn 100 Calorie Singles, 3 1.2 oz (34 g) Net Wt 4.8 oz (136 g), American Pop Corn Co. Sioux City, Iowa Event 87935 | American Pop Corn Co | Food | Class I | 1 |
| 12 May 2021 | Lipodrene With 25mg Ephedra Extract 100CT UPC 8 57084 00056 9 Event 87919 | Hi Tech Pharmaceuticals | Food | Class II | 1 |
| 12 May 2021 | Wegmans Food You Feel Good About Everything Bagel Seasoned Hummus, 8oz packaged in a clear plastic container with a clear plastic snap lid | Wegmans Food Markets, Inc. | Food | Class II | 1 |
| 11 May 2021 | Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220 | Medical Action Industries, Inc. 306 | Device | Class II | 5 |
| 11 May 2021 | Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32 | Skytron, Div. The KMW Group, Inc | Device | Class II | 1 |
| 11 May 2021 | Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg Event 87923 | Name withheld | Drug | Class II | 1 |
| 11 May 2021 | Mideo's Marinara Glass 32oz jars - 6 jars per case Event 87948 | RC Industries Inc. | Food | Class II | 1 |
| 10 May 2021 | Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001; | Ventec Life Systems, Inc. | Device | Class II | 1 |
| 10 May 2021 | BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338 | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 7 May 2021 | Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11 | Zimmer GmbH | Device | Class II | 2 |
| 7 May 2021 | DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 7 May 2021 | Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 | Beckman Coulter Inc. | Device | Class II | 2 |
| 7 May 2021 | Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc… | K2M, Inc | Device | Class II | 3 |
| 7 May 2021 | Sara Lee Pecan Pie 4oz. retail packaged UPC 032100051118, 24 and 48 count wholesale case; Chef Pierre Southern Pecan Pie, 10 slices, 36oz. retail packaged UPC 032100092739, 6 pies per wholesale case; Chef Pierre Pecan Pie, 10 slices, 36oz. retail packaged UPC 032100093750, 6 pies per wholesale case; Devonshire… Event 87913 | SARA LEE FROZEN FOODS | Food | Class I | 1 |
| 7 May 2021 | Peppa Pig brand chocolate chip cookies. One 7 oz bag per box- 6 boxes per case Event 87966 | PRIMARY COLORS DESIGN CORP | Food | Class I | 1 |
| 6 May 2021 | Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component. | Corin Ltd | Device | Class II | 2 |
| 6 May 2021 | ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50 | Johnson & Johnson Vision Care, Inc. | Device | Class II | 1 |
| 6 May 2021 | Kauffman's Fruit Farm & Market Sweet Apple Cider; Keep Refrigerated; Packaged in plastic bottles with screw-cap lids in the following sizes: 12-once: 25 bottles per case. 1/2-gallon: 9 bottles per case 1-gallon: 4 bottles per case. 350-gallon tote 250-gallon tote Event 87881 | A L Kauffman & Sons Co. DBA Kauffman's Fruit Farm and Market | Food | Class II | 1 |
| 6 May 2021 | Dole Yellow cling Peach Slices in 100% Fruit Juice. Snack & Store Fridge Pack. Net Wt 15 oz. (425g). UPC 38900-00642. Manufactured for Dole Packaged Foods, LLC, Westlake Village, CA 91361. Packed in Thailand. | Dole Packaged Foods, LLC | Food | Class III | 1 |
| 6 May 2021 | Wegmans brand Bagged Ice, 7lb, packaged in a clear plastic bag | Wegmans Food Markets, Inc. | Food | Class II | 1 |
| 5 May 2021 | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies. | Abbott Laboratories Inc. (St Jude Medical) | Device | Class II | 3 |
| 5 May 2021 | BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10 Event 87873 | Oxford Pharmaceuticals, LLC | Drug | Class II | 1 |
| 5 May 2021 | 365 Everyday Value Whey Protein Powder Natural Vanilla Flavor, Net Wt. 13.9 oz. canisters, UPC 9948228764, Whole Foods Market 550 Bowie Street Austin, TX 78703. Store in a cool, dry place. Event 87902 | Arizona Nutritional Supplements | Food | Class I | 1 |
| 5 May 2021 | Wild Rice Tomato Soup, UPC 91675-31004, The Secret Garden, Park Rapids, MN 56470 | The Secret Garden of Park Rapids, Inc. | Food | Class II | 3 |
| 4 May 2021 | ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is… | Viewray, Inc. | Device | Class II | 1 |
| 4 May 2021 | Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are not defined as they… Event 87952 | Name withheld | Device | Class I | 1 |
| 4 May 2021 | Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 4 May 2021 | Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 | Boehringer Ingelheim Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 4 May 2021 | Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05. Event 87879 | Name withheld | Drug | Class III | 1 |
| 4 May 2021 | Ruffles All Dressed Potato Chips 16 1/8 oz. packaged in flexible plastic bags UPC 28400 56520 | Frito-Lay, Inc. Headquarters | Food | Class I | 1 |
| 4 May 2021 | Garlic Alfredo Sauce. Product code 20607981. Keep Frozen. Net Wt. 30 lb. (13.61KG) Distributed By: Kerry Inc., Beloit, WI 53511. | Kerry Global Technology Innovation Center | Food | Class II | 2 |
| 3 May 2021 | VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDC’s formulation of VTM. | Ortho-Clinical Diagnostics, INc. | Device | Class II | 1 |
| 3 May 2021 | 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. | PFIZER, INC | Drug | Class I | 2 |
| 3 May 2021 | Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02 | Mylan Institutional LLC | Drug | Class III | 1 |
| 30 Apr 2021 | WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US | Wishbone Medical, Inc. | Device | Class II | 1 |
| 30 Apr 2021 | CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract | CooperSurgical, Inc. | Device | Class II | 1 |
| 30 Apr 2021 | Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation. | Medline Industries Inc | Device | Class II | 1 |
| 30 Apr 2021 | NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System. | Nico Corp. | Device | Class II | 2 |
| 30 Apr 2021 | Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 30 Apr 2021 | Garden Cut Coleslaw W/ Carrot Organic, 1lb plastic clamshell, UPC 053495081016, 4 1lb retail units per wholesale case. Item number: CACO41L / 17671 | Indianapolis Fruit Company, Inc. | Food | Class II | 1 |
| 29 Apr 2021 | Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA | Exact Medical Manufacturing, Inc. | Device | Class II | 18 |
| 29 Apr 2021 | Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | Device | Class II | 25 |
| 29 Apr 2021 | Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors. | Covidien, LP | Device | Class II | 4 |
| 29 Apr 2021 | Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30. | Ascend Laboratories LLC | Drug | Class III | 1 |
| 29 Apr 2021 | NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 | Acella Pharmaceuticals, LLC | Drug | Class I | 5 |
| 28 Apr 2021 | Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10 | Fresenius Medical Care Holdings, Inc. | Drug | Class II | 8 |
| 28 Apr 2021 | 6" Round Croissant Crust 100 Count Bulk, frozen, Net Weight: 6.25 lbs. Croissant Etc. Corp., Greendale, WI 53129 Event 87861 | Croissant Etc Corp | Food | Class II | 1 |
| 27 Apr 2021 | Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve. | Medtronic Sofamor Danek USA, Inc | Device | Class II | 1 |
| 27 Apr 2021 | Olympus Sterile Optical Laser Fiber, single use and reusable | Quanta System, S.p.A. | Device | Class II | 3 |
| 27 Apr 2021 | The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14 | Circulatory Technology Inc. | Device | Class II | 1 |
| 27 Apr 2021 | Robinson Fresh, Turnip Greens, 1lb. packages / Bags, 8 packages per case , Perishable/Keep Refrigerated . BEST IF USED BY 04/26/21 . | Safeway Fresh Foods LLC | Food | Class I | 1 |
| 27 Apr 2021 | 10194739 TranSmart" 12 INCH CHOCOLATE CHIP MESSAGE COOKIE 24/24 OUNCE CHOCOLATE CHIP COOKIES IN BAKEABLE PLASTIC PANS WITH DOMES KEEP FROZEN AT 0°F OR BELOW Net weight: 36 lb (16.33 kg) (24 x 24 oz (680g)) | Brill Inc | Food | Class II | 3 |
| 26 Apr 2021 | Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2,… | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD | Device | Class I | 2 |
| 26 Apr 2021 | IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 26 Apr 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422 | Alphatec Spine, Inc. | Device | Class II | 29 |
| 26 Apr 2021 | REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery. | Meta C.G.M. Spa | Device | Class II | 4 |
| 26 Apr 2021 | Brew Dr. Uplift Blueberry Raspberry Yerba Mate Guayusa, Green Tea, Natural Caffeine With Probiotics. 12/16 oz. aluminum cans per cardboard flat. UPC 8 57161 00867 9. The label is read in parts: "***BLUEBERRY RASPBERRY ***YERBA MATE * GUAYUSA * GREEN TEA***BREW DR UPLIFT *** NATURAL CAFFEINE + PROBIOTICS *** CONTAIN… | Name withheld | Food | Class II | 3 |
| 23 Apr 2021 | Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide… Event 87812 | Adler MicroMed, Inc. | Device | Class II | 1 |
| 23 Apr 2021 | The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2 | CooperSurgical, Inc. | Device | Class II | 1 |
| 23 Apr 2021 | Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X | Philips North America Llc | Device | Class II | 2 |
| 22 Apr 2021 | GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings. | Welch Allyn Inc | Device | Class II | 2 |
| 21 Apr 2021 | RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 . | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 21 Apr 2021 | VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. | MICROVENTION INC. | Device | Class III | 3 |
| 21 Apr 2021 | Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment. Event 87847 | Dentech Corp. | Device | Class II | 1 |
| 21 Apr 2021 | Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493 | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 21 Apr 2021 | Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2. | Pentax of America Inc | Device | Class II | 1 |
| 21 Apr 2021 | Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300 Event 87795 | Anodyne Surgical | Device | Class II | 1 |
| 20 Apr 2021 | Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine. | Medivators, Inc. | Device | Class II | 1 |
| 20 Apr 2021 | Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant. | Signature Orthopedics Pty Limited | Device | Class II | 1 |
| 20 Apr 2021 | Multitom RAX with software version VF10 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 20 Apr 2021 | Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud | Elekta, Inc. | Device | Class II | 1 |
| 19 Apr 2021 | Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application | GE Healthcare, LLC | Device | Class II | 1 |
| 19 Apr 2021 | Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content. | CHANGE HEALTHCARE CANADA COMPANY | Device | Class II | 1 |
| 19 Apr 2021 | Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP | EHOB, Inc. | Device | Class II | 1 |
| 19 Apr 2021 | GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems. | GE Healthcare, LLC | Device | Class II | 1 |
| 19 Apr 2021 | Bake n Show Angel Food Tray 8 Inch & 8 inch shallow | Genpak | Food | Class II | 5 |
| 16 Apr 2021 | FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 16 Apr 2021 | Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. | Hardy Diagnostics | Device | Class II | 1 |
| 16 Apr 2021 | Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. | Draeger Medical, Inc. | Device | Class II | 4 |
| 16 Apr 2021 | The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free… | Terumo Cardiovascular Systems Corporation | Device | Class II | 3 |
| 15 Apr 2021 | Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system Event 87752 | Getinge (Suzhou) Co Ltd | Device | Class II | 1 |
| 15 Apr 2021 | T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300 | Flower Orthopedics Corporation | Device | Class II | 1 |
| 15 Apr 2021 | Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS. | Vygon U.S.A. | Device | Class II | 1 |
| 14 Apr 2021 | Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. | Baxter Healthcare Corporation | Device | Class II | 1 |
| 14 Apr 2021 | Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part. | Radiometer Medical ApS | Device | Class II | 3 |
| 14 Apr 2021 | Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e | Beckman Coulter Inc. | Device | Class II | 1 |
| 13 Apr 2021 | BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306 | Philips North America Llc | Device | Class II | 1 |
| 9 Apr 2021 | ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04 | Avid Medical, Inc. | Device | Class I | 4 |
| 9 Apr 2021 | COVID-19 Self-Test Kit *** INNOVA *** 7T | INNOVA MEDICAL GROUP, INC. | Device | Class I | 3 |
| 8 Apr 2021 | Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22 2 Prep ChloraPrep One-Step 3 1 Dressing… | Windstone Medical Packaging, Inc. | Device | Class II | 2 |
| 6 Apr 2021 | BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178 | Philips Respironics, Inc. | Device | Class II | 6 |
| 1 Apr 2021 | Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue. | CLINICAL LASERTHERMIA SYSTEMS AB | Device | Class II | 3 |
| 29 Mar 2021 | NPr FCZ Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339 | Nobel Biocare Procera LLC | Device | Class II | 5 |
| 26 Mar 2021 | PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518 PICO70 w/o needle; 956-519 PICO70 w/o needle;… | Radiometer Medical ApS | Device | Class II | 1 |
| 25 Mar 2021 | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures. | Zavation | Device | Class II | 71 |
| 25 Mar 2021 | Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel. Event 87768 | The Biomed Guys | Device | Class I | 1 |
| 22 Mar 2021 | Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. | Normand-Info S.A.S.U. | Device | Class II | 1 |
| 16 Mar 2021 | FREESTYLE LANCETS 28G 100CT Item Number:2975670 | Cardinal Health Inc. | Device | Class II | 14 |
| 15 Mar 2021 | MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL; KIT MMT-1896WW MM780G 6.5W BLE SF MG; PUMP MMT-1884XC 780G V6.5 CLIN US MG; PUMP MMT-1885XC 780G V6.5 CLIN MM; PUMP MMT-1886XC 780G V6.5 CLIN MG; PUMP MMT-1885L MM780G… | Name withheld | Device | Class II | 2 |
| 15 Mar 2021 | THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS | Cardinal Health Inc. | Drug | Class II | 198 |
| 1 Mar 2021 | MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device. Event 87804 | James Leckey Design Ltd | Device | Class II | 1 |
| 2 Feb 2021 | IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. | Philips North America Llc | Device | Class II | 1 |
| 14 Dec 2020 | VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060 Venovo 10F 16/60/1200mm OUS VENEL16080 Venovo 10F 16/80/1200mm OUS VENEL16100 Venovo 10F 16/100/1200mm OUS VENEL16120 Venovo 10F 16/120/1200mm OUS VENEL16140 Venovo 10F 16/140/1200mm OUS VENEL16160… | Bard Peripheral Vascular Inc | Device | Class II | 3 |
| 11 Feb 2020 | NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use Event 87827 | MARVAO MEDICAL DEVICES LTD. | Device | Class II | 1 |
| 4 Jun 2019 | inLight Medical LED Pads used with Polychromatic light technology system Event 85106 | Inlightened Partners LLC | Device | Class III | 1 |
| 23 Jun 2016 | Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058. | Philips Medical Systems Nederlands | Device | Class II | 1 |