Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesPRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX ST100 SET US, Product Code 107636US; 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 DevicesPRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRIMSAFLEX M100 SET, Product Code 106697; 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 DevicesExploro Highly Sensitive Male Fertility / Sperm Concentration Test
Exploro Highly Sensitive Male Fertility / Sperm Concentration 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 FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Apple and Cinnamon- UPC# 5065006235776
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Apple and Cinnamon- UPC# 5065006235776
potential Clostridium botulinum contamination
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; 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 Model/Catalog Number: KD-V431M-0720; 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 DevicesFDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
FDA DevicesVortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25
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 DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 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 Model/Catalog Number: KD-V411M-3025 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.
NHTSAGeneral Rubber (Thailand) Co., Ltd - Tires May Crack and Separate/FMVSS 139
General Rubber (Thailand) Co., Ltd - Tires May Crack and Separate/FMVSS 139
Tire failure can cause a sudden loss of tire pressure, increasing the risk of a crash.
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 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 FoodSofit, Seedless Red Dates, 12 oz package, Plastic bags, 50 packages per case
Sofit, Seedless Red Dates, 12 oz package, Plastic bags, 50 packages per case
Undeclared sulfites
AustraliaH3 Hintermann Ankle Replacement System
H3 Hintermann Ankle Replacement System
The TGA has concerns about an increased risk of revision as shown in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) data when compared to other fixed and mobile b...
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 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.
RappelConsoconserverie la granvillaise - rillettes conserverie la granvillaise
conserverie la granvillaise - rillettes conserverie la granvillaise
défaut de fabrication
RappelConsola ferme aux biches - conserves de cerf
la ferme aux biches - conserves de cerf
perte de maitrise du process de sterilisation
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.
FDA FoodJUICE from the Raw, cashew coffee milk
JUICE from the Raw, cashew coffee milk
Under-processed product may contain pathogenic bacteria that could harm to humans.
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 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 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 FoodLost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged
Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged
Recall is due to a misprint on the label that incorrectly identifies the total caffeine content on the can. The item contains 300mg of caffeine, instead of 150mg as provided on the can.
FDA FoodOptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.
OptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.
The firm initiated a voluntary recall after NSF testing showed that labeled ingredient quantities did not align with analytical test results, manganese level was below label quantity.