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High RiskFDA
Covidien, Lp
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Heartware, Inc.
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory ...
Medical Implants·1 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Tornier, Inc
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Marti...
Medical Implants·20 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
Surgical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Southwest Technologies Inc
Stimulen Collagen Moisturizing Lotion, ST9555B
Medical Devices·2,016 affected·May 28, 2021
High RiskFDA
Cell Marque Corporation
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
Medical Devices·2 affected·May 27, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Diagnostic Devices·116 affected·May 27, 2021
High RiskFDA
Stryker Gmbh
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Medical Devices·52 affected·May 27, 2021
High RiskFDA
Cytocell Ltd.
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Diagnostic Devices·23 affected·May 27, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using et...
Medical Devices·290 affected·May 26, 2021
High RiskFDA
Ion Beam Applications S.a.
Proteus 235-Proton Therapy System
Medical Devices·5 affected·May 26, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
Medical Devices·50 affected·May 26, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Medical Devices·1,679 affected·May 26, 2021
High RiskFDA
Naturo Aid Pharmaceutical Inc.
Vita Aid SynerClear (Unflavoured), VA-925. The product is a powder, packaged in a plastic bottle and a white cap, with a net weight of 6...
Food·302 affected·May 25, 2021
High RiskFDA
Naturo Aid Pharmaceutical Inc.
Vita Aid SynerClear (Chocolate), VA-012. The product is a powder, packaged in a plastic bottle and a white cap, with a net weight of 650g.
Snacks & Candy·1,026 affected·May 25, 2021
High RiskFDA
Faribault Foods, Inc.
Whole Foods Market Organic Dark Red Kidney Beans, Net Wt 15.5 oz. (439g) UPC 99482-45272. Distributed by: Whole Foods Market, Austin, ...
Food·22,440 affected·May 25, 2021
High RiskFDA
Naturo Aid Pharmaceutical Inc.
Vita Aid Keto-Elemental Nutrition (Chocolate), VA-958. The product is a powder, packaged in an aluminum bag , with a net weight of 315g.
Snacks & Candy·910 affected·May 25, 2021
High RiskFDA
Naturo Aid Pharmaceutical Inc.
Vita Aid SynerClear (Vanilla), VA-924. The product is a powder, packaged in a plastic bottle and a white cap, with a net weight of 650g.
Food·3,072 affected·May 25, 2021
High RiskFDA
Medline Industries Inc
Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft and strong 100 c...
Medical Devices·214,035 affected·May 25, 2021
High RiskFDA
Remote Diagnostic Technologies Ltd.
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Produ...
Medical Devices·510 affected·May 25, 2021
High RiskFDA
Hill Dermaceuticals, Inc.
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, F...
Drugs·34,561 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as ...
Surgical Devices·6,461 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective p...
Surgical Devices·1,638 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient cove...
Surgical Devices·574 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as protective patient ...
Surgical Devices·15,360 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient ...
Surgical Devices·26,250 affected·May 21, 2021
High RiskFDA
Sunstar Americas, Inc.
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by...
Medical Devices·124,064 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective patient coverings, ...
Surgical Devices·13,426 affected·May 21, 2021
High RiskFDA
Cardinal Health 200, Llc
Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protective patient coveri...
Surgical Devices·5,342 affected·May 21, 2021
High RiskFDA
Ge Healthcare, Llc
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Medical Devices·111,728 affected·May 21, 2021
High RiskFDA
Kumpunny's Llc
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...
Dairy·36 affected·May 20, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-...
Topical Drugs·9,587 affected·May 20, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-...
Topical Drugs·6,689 affected·May 20, 2021
High RiskFDA
Randall Foods, Inc.
RANDALL MIXED BEANS 48OZ glass jars UPC 070095000407; RANDALL MIXED BEANS 24OZ glass jars UPC 070095000414; RANDALL MIXED BEANS 15.4OZ gl...
Food·800,000 affected·May 19, 2021
High RiskFDA
Randall Foods, Inc.
RANDALL GREAT NORTHERN BEANS 48OZ glass jar UPC 070095000100; RANDALL GREAT NORTHERN BEANS 24OZ glass jar UPC 070095000117; RANDALL GREAT...
Food·800,000 affected·May 19, 2021
High RiskFDA
Randall Foods, Inc.
RANDALL NAVY BEANS 48OZ glass jars UPC 070095000506; RANDALL NAVY BEANS 15.4OZ glass jars UPC 070095000537
Food·800,000 affected·May 19, 2021
High RiskFDA
Randall Foods, Inc.
RANDALL KIDNEY BEANS 48OZ glass jars UPC 070095000308; RANDALL KIDNEY BEANS 24OZ glass jars UPC 070095000315; RANDALL KIDNEY BEANS 15.4OZ...
Food·800,000 affected·May 19, 2021