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CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter
Cardiac Devices·2,366 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter
Cardiac Devices·5,435 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter
Cardiac Devices·15,079 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter
Cardiac Devices·15,270 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter
Cardiac Devices·8,715 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter
Cardiac Devices·86,898 affected·Mar 21, 2024
CriticalFDA
Belgian Yummies
Vanilla Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
Dairy·1,208 affected·Mar 20, 2024
CriticalFDA
Belgian Yummies
Peanut Butter Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandw...
Dairy·60 affected·Mar 20, 2024
CriticalFDA
Belgian Yummies
Key Lime Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
Dairy·268 affected·Mar 20, 2024
CriticalFDA
Belgian Yummies
Raspberry Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
Dairy·110 affected·Mar 20, 2024
CriticalFDA
Belgian Yummies
Chocolate Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
Dairy·892 affected·Mar 20, 2024
CriticalFDA
Belgian Yummies
Salted Caramel Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sand...
Dairy·254 affected·Mar 20, 2024
CriticalFDA
Belgian Yummies
Belgian Yummies Homemade Ice Cream Horchata Gelato. Packaged in 4.75 Liter gray pan.
Dairy·12 affected·Mar 20, 2024
CriticalFDA
Pyramids Wholesale Inc.
Weiner Boner Honey, 12g packet, 100% Organic Formula.
Drugs·19 affected·Mar 19, 2024
CriticalFDA
Pyramids Wholesale Inc.
Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.
Drugs·0 affected·Mar 19, 2024
CriticalFDA
Pyramids Wholesale Inc.
Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
Drugs·149 affected·Mar 19, 2024
CriticalFDA
Pyramids Wholesale Inc.
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
Oral Drugs·45 affected·Mar 19, 2024
CriticalFDA
Pyramids Wholesale Inc.
Samurai-X Honey 6800, UPC 2 56891 27553 3.
Drugs·0 affected·Mar 19, 2024
CriticalFDA
Pyramids Wholesale Inc.
ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
Drugs·4,351 affected·Mar 19, 2024
CriticalFDA
Pyramids Wholesale Inc.
HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A
Drugs·19 affected·Mar 19, 2024
CriticalFDA
Pyramids Wholesale Inc.
SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762
Drugs·7 affected·Mar 19, 2024
CriticalFDA
Pyramids Wholesale Inc.
The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 6163...
Drugs·10 affected·Mar 19, 2024
CriticalFDA
Pyramids Wholesale Inc.
libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
Oral Drugs·7 affected·Mar 19, 2024
CriticalFDA
Pyramids Wholesale Inc.
GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
Drugs·12 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Respiratory Devices·9,999 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Respiratory Devices·1,002 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Respiratory Devices·775 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Respiratory Devices·789 affected·Mar 19, 2024
CriticalFDA
Wenders Llc
Trader Joe's 50% Less Sodium Roasted & Salted Whole Cashews Net Wt. 15 oz (1 LB) 454g Dist. & Sold Exclusively By: Trader Joe's, Monrovia...
Food·6,001 affected·Mar 15, 2024
CriticalFDA
Biomerieux Inc
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF...
Diagnostic Devices·49,215 affected·Mar 14, 2024
CriticalFDA
Hologic, Inc
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x ...
Medical Devices·53,492 affected·Mar 13, 2024
CriticalFDA
Kick Ash Products Llc
Kick Ash Products, Door County Love Dark Chocolate Cherry Granola, 1lb, laminated resealable bag
Bakery & Grains·66 affected·Mar 12, 2024
CriticalFDA
Nrs Enterprises, Inc. Dba Sunflour Bakery
Sunflour Bakery Banana Nut Sweet Bread, 16 oz, clear poly bag
Bakery & Grains·316 affected·Mar 8, 2024
CriticalFDA
Nrs Enterprises, Inc. Dba Sunflour Bakery
German Home Bakery Hazelnut Coffee Cake, 16 oz, clear poly bag
Bakery & Grains·156 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovascul...
Medical Devices·117 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the ne...
Surgical Devices·200 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into ...
Medical Devices·750 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neu...
Medical Devices·10 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasc...
Medical Devices·19 affected·Mar 8, 2024
CriticalFDA
John B. Sanfilippo & Son Inc.
Great Value Honey Roasted Cashews, 8.25oz. plastic can, UPC 0 78742 13334 8
Food·17,184 affected·Mar 7, 2024
CriticalFDA
Stonewall Kitchen, Llc
Stonewall Kitchen Cinnamon Sugar Doughnut Mix; Gluten Free; Home-Baked & Gluten Free; Net Wt. 18oz (510g); UPC: 1138131332
Food·2,405 affected·Mar 7, 2024
CriticalFDA
Wesco Central Commissary
Wesco mint no-bake cookie bites 9oz cup UPC 750308040474
Bakery & Grains·1,248 affected·Mar 7, 2024
CriticalFDA
Fresenius Kabi Usa, Llc
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Medical Devices·17 affected·Mar 7, 2024
CriticalFDA
Outset Medical, Inc.
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Medical Devices·919 affected·Mar 6, 2024
CriticalFDA
Tandem Diabetes Care, Inc.
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Diabetes Devices·85,863 affected·Mar 5, 2024
CriticalFDA
Par Sterile Products Llc
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distribu...
Injectable Drugs·466 affected·Mar 4, 2024
CriticalFDA
Alere San Diego, Inc.
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Medical Devices·559 affected·Mar 1, 2024
CriticalFDA
Sleepnet Corporation
Mojo 2 Full Face AAV Non Vented Mask, All Sizes
Medical Devices·1,268 affected·Mar 1, 2024