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High RiskFDA
Ani Pharmaceuticals, Inc.
Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distribute...
Oral Drugs·5,477 affected·Feb 15, 2022
High RiskFDA
Ani Pharmaceuticals, Inc.
Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Di...
Oral Drugs·70,788 affected·Feb 15, 2022
High RiskFDA
Ani Pharmaceuticals, Inc.
Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000...
Oral Drugs·173,499 affected·Feb 15, 2022
High RiskFDA
Meridian Bioscience Inc
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog N...
Diagnostic Devices·452 affected·Feb 15, 2022
High RiskFDA
Baxter Healthcare Corporation
Compella Therapy Air Supply Unit
Medical Devices·6,022 affected·Feb 14, 2022
High RiskFDA
Draeger Medical, Inc.
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog N...
Respiratory Devices·24,337 affected·Feb 14, 2022
High RiskFDA
Biomet, Inc.
BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, whic...
Medical Devices·12 affected·Feb 14, 2022
High RiskFDA
Biomet, Inc.
BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #1100182...
Medical Devices·702 affected·Feb 14, 2022
High RiskFDA
Biomet, Inc.
BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X1...
Medical Devices·2,594 affected·Feb 14, 2022
High RiskFDA
Draeger Medical, Inc.
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 ...
Respiratory Devices·13,687 affected·Feb 14, 2022
High RiskFDA
Biomet, Inc.
BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [It...
Medical Devices·38 affected·Feb 14, 2022
High RiskFDA
Abbott Molecular, Inc.
Alinity m Integrated Reaction Units (IRU)
Medical Devices·3,063 affected·Feb 11, 2022
High RiskFDA
Philips Medical Systems
CombiDiagnost R90 1.1 (709031)
Diagnostic Devices·130 affected·Feb 11, 2022
High RiskFDA
Ardent Mills, Llc
Ardent Mills Hotel and Restaurant All Purpose Flour - AA, 50 lb. (22.68kg) bag, UPC 6 78008 00053 9, Ardent Mills, Denver, CO 80202. Mill...
Food·1,450 affected·Feb 10, 2022
High RiskFDA
Vbest Inc
Salted Dried Plums, 500kgcartons, 20kgs plastic bag/carton
Food·50 affected·Feb 10, 2022
High RiskFDA
J & M Foods, Inc.
Favorite Day Carrot cake soft bake cookies Net Wt 8 oz. (227g) UPC 0 885239 25803 3 packaged in gable top carton 6 units per case
Bakery & Grains·9,309 affected·Feb 10, 2022
High RiskFDA
Nextremity Solutions
Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
Surgical Devices·89 affected·Feb 10, 2022
High RiskFDA
Nextremity Solutions
Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
Surgical Devices·239 affected·Feb 10, 2022
High RiskFDA
Nextremity Solutions
Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
Surgical Devices·285 affected·Feb 10, 2022
High RiskFDA
Ponder Foods Llc
Pretty Thai Sweet Chili Stir Fry & Barbecue Sauce NET WT. 11.2 oz (317g) UPC 860043001224 packaged in a cylindrical clear PET plastic bo...
Food·919 affected·Feb 9, 2022
High RiskFDA
Lannett Company, Inc.
Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc.,...
Oral Drugs·23,598 affected·Feb 9, 2022
High RiskFDA
Maquet Cardiovascular, Llc
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Medical Devices·60 affected·Feb 9, 2022
High RiskFDA
Wright Medical Technology, Inc.
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2....
Medical Devices·12 affected·Feb 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Medical Devices·199 affected·Feb 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
Medical Devices·2,158 affected·Feb 9, 2022
High RiskFDA
Biomerieux, Inc.
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Medical Devices·480 affected·Feb 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Medical Devices·6,606 affected·Feb 9, 2022
High RiskFDA
Candies Tolteca
Tolteca Saladitos con Chile Limon, Dried Plums with Chili & Lemon; Net Wt. .15 oz. (42.5g) packaged in a clear cellophane bag approximate...
Produce·1,248 affected·Feb 7, 2022
High RiskFDA
Candies Tolteca
Tolteca Saladitos Salted Dried Plums; Net Wt. 1.5 oz. (42.5g) packaged in a clear cellophane bag approximately (4 x 8 ). The name SALAD...
Produce·1,248 affected·Feb 7, 2022
High RiskFDA
American Gourmet
American Gourmet Saladitos (Dried Salted Plums) 1.5 oz. package UPC: 1578600104
Produce·193 affected·Feb 7, 2022
High RiskFDA
Sun Pharmaceutical Industries Inc
Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 1...
Oral Drugs·59,232 affected·Feb 7, 2022
High RiskFDA
Rising Pharmaceuticals
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle ...
Oral Drugs·2,220 affected·Feb 7, 2022
High RiskFDA
Tsm Brands Llc
Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 86...
Drugs·135 affected·Feb 7, 2022
High RiskFDA
Teligent Pharma, Inc.
Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McK...
Topical Drugs·11,040 affected·Feb 7, 2022
High RiskFDA
Tsm Brands Llc
70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Ma...
Drugs·1 affected·Feb 7, 2022
High RiskFDA
Philips North America, Llc
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 2107...
Medical Devices·478,931 affected·Feb 7, 2022
High RiskFDA
Brius Technologies Inc.
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Devi...
Medical Devices·4 affected·Feb 7, 2022
High RiskFDA
Rojas Inc.
LUPAG brand Plain Dried Salted Plums, net wt. 0.5oz, pre-priced at $.99 packaged in transparent poly bags sealed with a cardboard header,...
Food·833 affected·Feb 6, 2022
High RiskFDA
Professional Disposables International, Inc.
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Eac...
Drugs·160,531 affected·Feb 4, 2022
High RiskFDA
Professional Disposables International, Inc.
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.17...
Drugs·9,518 affected·Feb 4, 2022
High RiskFDA
Professional Disposables International, Inc.
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. ...
Drugs·28,201 affected·Feb 4, 2022
High RiskFDA
Philips North America Llc
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Cardiac Devices·1,696,047 affected·Feb 4, 2022
High RiskFDA
Philips North America Llc
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STER...
Cardiac Devices·331,712 affected·Feb 4, 2022
High RiskFDA
A & E Corrales Llc
Saladitos With Chili, Net Weight 16 oz (1lb) with UPC 0661799748162. The product is packaged in ultra clear sealed zip-lock plastic bag....
Produce·12 affected·Feb 3, 2022
High RiskFDA
Pacific Golden Coast Trading Inc
Dried salted plum, packaged in 22 lbs. carton. Product of China.
Food·820 affected·Feb 3, 2022
High RiskFDA
Abbott Laboratories, Inc
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro di...
Diagnostic Devices·306 affected·Feb 3, 2022
High RiskFDA
El Chavito
El Chavito¿ Saladitos Dried Salted Plums, net wt. 1.7 oz bag, Individual UPC 859470006049, Master Case UPC 859470006629. El Chavito¿ Sal...
Produce·37,552 affected·Feb 2, 2022
High RiskFDA
El Super Leon Ponchin Snacks, Inc.
El Super Leon brand, Dry Salted Plum with Chili, Shelf Stable, packaged in plastic bag, Net Wt 1.05oz, UPC 8-52605-00408. With 12 packs o...
Snacks & Candy·4,134 affected·Feb 2, 2022