Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA FoodItem 81153 Kroger Chinese Inspiration Vegetable Fried Rice - Blend of long grain rice assorted vegetables & egg. Net wt. 22oz. Retail box UPC 011110041623. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 6/22oz. boxes or 8.25 lbs. per case. Case UPC 10011110041620. All products are intended to be stored frozen and fully cooked to 165F before eating.
Item 81153 Kroger Chinese Inspiration Vegetable Fried Rice - Blend of long grain rice assorted vegetables & egg. Net wt. 22oz. Retail box UPC 011110041623. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 6/22oz. boxes or 8.25 lbs. per case. Case UPC 10011110041620. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
FDA FoodTops GOLD Khatta Meetha Pickle NET QTY.: 33.51oz PRODUCT OF INDIA UPC: 8904288611427 INGREDIENTS:***Mustard Oil***
Tops GOLD Khatta Meetha Pickle NET QTY.: 33.51oz PRODUCT OF INDIA UPC: 8904288611427 INGREDIENTS:***Mustard Oil***
Potential adulteration with erucic acid from mustard oil ingredient.
FDA FoodSunflour Bakery Hamburger Bun, 18oz plastic bag containing 6 buns. UPC- 832971001522
Sunflour Bakery Hamburger Bun, 18oz plastic bag containing 6 buns. UPC- 832971001522
Undeclared sesame seed ingredient in hamburger buns.
FDA FoodItem 5654390 Ajinomoto Golden Tiger Vegetable Fried Rice - Long grain white rice and crispy vegetables in a savory sauce. Net wt. 3lbs per bag. Retail bag UPC 076366565439. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/3lb. bags or 12 lbs. per case. Case UPC 10076366565436. All products are intended to be stored frozen and fully cooked to 165F before eating.
Item 5654390 Ajinomoto Golden Tiger Vegetable Fried Rice - Long grain white rice and crispy vegetables in a savory sauce. Net wt. 3lbs per bag. Retail bag UPC 076366565439. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/3lb. bags or 12 lbs. per case. Case UPC 10076366565436. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
FDA FoodItem 5650883 Ajinomoto Teppanyaki Style Vegetable Fried Rice - Japanese-style fried rice made with colorful vegetables in an aromatic garlic butter sauce. There are 6/9oz. bags per box or 54oz per box. Retail box UPC 071757508835. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 8/54oz boxes or 27lb. per case. Case UPC 10071757508832. All products are intended to be stored frozen and fully cooked to 165F before eating.
Item 5650883 Ajinomoto Teppanyaki Style Vegetable Fried Rice - Japanese-style fried rice made with colorful vegetables in an aromatic garlic butter sauce. There are 6/9oz. bags per box or 54oz per box. Retail box UPC 071757508835. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 8/54oz boxes or 27lb. per case. Case UPC 10071757508832. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
FDA DevicesBrand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
FDA Devices16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
FDA DevicesVolar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
FDA DevicesFlexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Probes may rupture/burst during activation
FDA DevicesPhilips X7-2 Ultrasound Transducer
Philips X7-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
FDA FoodTops GOLD Mango Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611373 INGREDIENTS:***Mustard Oil*** Tops GOLD Mango Pickle NET QTY.: 158.73oz PRODUCT OF INDIA UPC: 8904288611915; 8904288613025 INGREDIENTS:***Mustard Oil***
Tops GOLD Mango Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611373 INGREDIENTS:***Mustard Oil*** Tops GOLD Mango Pickle NET QTY.: 158.73oz PRODUCT OF INDIA UPC: 8904288611915; 8904288613025 INGREDIENTS:***Mustard Oil***
Potential adulteration with erucic acid from mustard oil ingredient.
FDA DevicesBrand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
NHTSAMack Trucks, Inc. - Turn Signal Failure/FMVSS 108
Mack Trucks, Inc. - Turn Signal Failure/FMVSS 108
Turn signals that do not function properly may fail to indicate the driver's intention to change vehicle direction, increasing the risk of a crash.
FDA DevicesHCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
FDA DevicesPhilips L12-5 Ultrasound Transducer
Philips L12-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
FDA DevicesCentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
FDA DevicesPuracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
RappelConsodonna indiana / queen care - gluhen hair cuticle restore mask / gloss volume reducer liso espelhado
donna indiana / queen care - gluhen hair cuticle restore mask / gloss volume reducer liso espelhado
présence d’une substance interdite : formaldéhyde (cancérogène/mutagène)
FDA FoodItem 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, vegetables & fried rice with oyster flavored sauce. Net wt. 48oz or 3lbs. per box. Retail box UPC 070077811465. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/48oz. boxes or 12lbs. per case. Case UPC 10070077811462. All products are intended to be stored frozen and fully cooked to 165F before eating.
Item 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, vegetables & fried rice with oyster flavored sauce. Net wt. 48oz or 3lbs. per box. Retail box UPC 070077811465. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/48oz. boxes or 12lbs. per case. Case UPC 10070077811462. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
FDA FoodItem 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct. Net wt. 8.92oz. per package. Retail package UPC: 071757055483. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 20/8.92oz. packages or 11.15 lbs. per case. Carton UPC 10071757055480. All products are intended to be stored frozen and fully cooked to 165F before eating.
Item 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct. Net wt. 8.92oz. per package. Retail package UPC: 071757055483. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 20/8.92oz. packages or 11.15 lbs. per case. Carton UPC 10071757055480. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
FDA DrugsGelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35
Failed Tablet/Capsule Specifications
FDA DevicesBrand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
FDA DevicesMiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).
FDA DevicesProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.