Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesConvenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
FDA DevicesPRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
FDA DrugsTrazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
Presence of Foreign Tablets/Capsules
Australia ProductsCharger for ultra-light cordless leaf blower
Charger for ultra-light cordless leaf blower
The charger does not meet Australian electrical safety requirements as the plug pins are uninsulated and it does not have the required Australian Regulatory Compliance Mark.
Australia ProductsKawasaki Teryx 4 H2 side by side utility terrain vehicle
Kawasaki Teryx 4 H2 side by side utility terrain vehicle
The CVT drive converter may fail in affected vehicles which could result in metal fragments being discharged.
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango- UPC# 5065006235875
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango- UPC# 5065006235875
potential Clostridium botulinum contamination
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Orange- UPC# 5061033692926
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Orange- UPC# 5061033692926
potential Clostridium botulinum contamination
FDA DevicesOXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango and Pineapple- UPC# 5065006235301
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango and Pineapple- UPC# 5065006235301
potential Clostridium botulinum contamination
FDA FoodWilly Pete's Chocolates brand Almond Despair; Dark Chocolate with Coconuts, Almonds, & Carolina Reapers; Ingredients: Sugar, Vegetable Oil, (Palm Kernel Oil & Hydrogentated Palm Kernel Oil), Cocoa Powder (processed with Alkali), Soy Lecithin (An Emulsifier), Whey Powder (Milk) & Salt. Coconut, Sugar, Water Propylene Glycol (Sustains Freshness), Salt, Sodium Metabisulfite (Preserves Whiteness). Macadamia nuts & Carolina Reaper Powder; Contains Milk and Soy. Tree Nuts. May contain traces of peanuts; UPC: 0 987261 5
Willy Pete's Chocolates brand Almond Despair; Dark Chocolate with Coconuts, Almonds, & Carolina Reapers; Ingredients: Sugar, Vegetable Oil, (Palm Kernel Oil & Hydrogentated Palm Kernel Oil), Cocoa Powder (processed with Alkali), Soy Lecithin (An Emulsifier), Whey Powder (Milk) & Salt. Coconut, Sugar, Water Propylene Glycol (Sustains Freshness), Salt, Sodium Metabisulfite (Preserves Whiteness). Macadamia nuts & Carolina Reaper Powder; Contains Milk and Soy. Tree Nuts. May contain traces of peanuts; UPC: 0 987261 5
Almonds are not declared in the ingredient statement. Almond is included in description of product on front label.
RappelConsola ferme aux biches - conserves de cerf
la ferme aux biches - conserves de cerf
perte de maitrise du process de sterilisation
FDA FoodBread and Roll Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
Bread and Roll Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
Undeclared Milk Allergen
FDA FoodBarbaCuban 90 Miles to Mojo Marinade, Net Wt 12 oz (355 ml) 12 oz glass bottles,1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00096 0
BarbaCuban 90 Miles to Mojo Marinade, Net Wt 12 oz (355 ml) 12 oz glass bottles,1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00096 0
Undeclared Quinine
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Soursop- UPC# 5061033691875
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Soursop- UPC# 5061033691875
potential Clostridium botulinum contamination
FDA DevicesVortex Surgical TID Pharos Illuminated Depressor, VS0801B
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
XXX
FDA Foodspicely ORGANIC garlic salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 3.4oz (96g) Ingredients: Salt, *Garlic *Organic www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007643
spicely ORGANIC garlic salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 3.4oz (96g) Ingredients: Salt, *Garlic *Organic www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007643
Product contains salt and is mislabeled
FDA FoodJUICE from the Raw, cashew milk
JUICE from the Raw, cashew milk
Under-processed product may contain pathogenic bacteria that could harm to humans.
FDA FoodSpice Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
Spice Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
Undeclared Milk Allergen
FDA DevicesVivoo Protein Test
Vivoo Protein Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
FDA DevicesEMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
RappelConsoconserverie la granvillaise - rillettes conserverie la granvillaise
conserverie la granvillaise - rillettes conserverie la granvillaise
défaut de fabrication
FDA DevicesTORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.