Safety Recall Directory
Browse and filter the latest official safety alerts globally.
les moulinettes - coquillettes pois chiches
les moulinettes - coquillettes pois chiches
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
les moulinettes - fusilli seigle
les moulinettes - fusilli seigle
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Joy Rose Lassi 16 oz.
Joy Rose Lassi 16 oz.
Product not adequately pasteurized
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM SET UP PACK DYNJ66260A ANGIOGRAPHY PACK DYNJ44293I ANGIOGRAPHY PACK-LF DYNJ0854485W CARDIAC CATH PACK DYNJ82709 CARDIAC CATH PACK-LF DYNJ0261554AL DYNJ31103F CATH LAB ANGIO TRAY DYNJ83506 CATH LAB PACK DYNJ66366C MSC-GREEN BAY ST VINCENT SAMPC0686 NEUROLOGICAL CATH PACK DYNJ63434B OR HYBRID-MRMC DYNJ907758B STEWARD OR ANGIO PACK GSS DYNJ80925B
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM SET UP PACK DYNJ66260A ANGIOGRAPHY PACK DYNJ44293I ANGIOGRAPHY PACK-LF DYNJ0854485W CARDIAC CATH PACK DYNJ82709 CARDIAC CATH PACK-LF DYNJ0261554AL DYNJ31103F CATH LAB ANGIO TRAY DYNJ83506 CATH LAB PACK DYNJ66366C MSC-GREEN BAY ST VINCENT SAMPC0686 NEUROLOGICAL CATH PACK DYNJ63434B OR HYBRID-MRMC DYNJ907758B STEWARD OR ANGIO PACK GSS DYNJ80925B
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Personalised bling dummy and clip set

Personalised bling dummy and clip set
The dummy and clip set does not comply with the mandatory standard for baby dummies and dummy chains . The decorations may detach from the dummy and clip. The dummy’s chain is too long.
boichik bagles Tuna Salad Ingredients: albacore tuna, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium disodium edta, natural flavors), pickle juice, mustard, chives, black pepper. Contains: Fish
boichik bagles Tuna Salad Ingredients: albacore tuna, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium disodium edta, natural flavors), pickle juice, mustard, chives, black pepper. Contains: Fish
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Lack of Assurance of Sterility
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767.
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767.
Incorrect product formulation: bag did not contain copper and famotidine per label.
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.
CGMP Deviations
les moulinettes - fusilli semi-complète
les moulinettes - fusilli semi-complète
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Potential for thrombus formation during prolonged use of the introducer.
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium disodium edta, natural flavors), pickle juice, mustard, chives, black pepper. Contains: Fish
boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium disodium edta, natural flavors), pickle juice, mustard, chives, black pepper. Contains: Fish
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
terres de moulin madame - farine de blé dur fine et complète
terres de moulin madame - farine de blé dur fine et complète
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC 8 70375 00511 1; 6 retail units per case Motor City Pizza Co. 5 Cheese Bread Twin retail pack; 44.86 oz. (2 lb. 12.9 oz.) 1272g UPC 8 70375 00509 8; 10 retail units per case
Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC 8 70375 00511 1; 6 retail units per case Motor City Pizza Co. 5 Cheese Bread Twin retail pack; 44.86 oz. (2 lb. 12.9 oz.) 1272g UPC 8 70375 00509 8; 10 retail units per case
potential salmonella contamination