Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA Foodboichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g Ingredients: Organic wheat flour ... Contains Wheat Topped flavors may additionally contain ... sesame seeds ... Best by SE 26 26 UPC: 850016588067
boichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g Ingredients: Organic wheat flour ... Contains Wheat Topped flavors may additionally contain ... sesame seeds ... Best by SE 26 26 UPC: 850016588067
Undeclared allergen, sesame.
FDA DevicesDa Vinci ASSY, PSS, SP1098, Part Number: 380601
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
FDA DevicesSurgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA DevicesAbiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Potential for thrombus formation during prolonged use of the introducer.
FDA FoodJoy Peach Lassi 16 oz.
Joy Peach Lassi 16 oz.
Product not adequately pasteurized
FDA DevicesSurgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA Food5# Sunflower Seeds C/NS
5# Sunflower Seeds C/NS
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
FDA DrugsSensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
CGMP Deviations
RappelConsoterres de moulin madame - semoule de blé dur
terres de moulin madame - semoule de blé dur
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
NHTSAHonda (American Honda Motor Co.) - Rearview Camera Image May Not Display/FMVSS 111
Honda (American Honda Motor Co.) - Rearview Camera Image May Not Display/FMVSS 111
A rearview image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.
FDA DevicesSurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
RappelConsoles moulinettes - fusilli seigle
les moulinettes - fusilli seigle
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
FDA DevicesConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
RSS FeedEunha Fisheries Co., LTD. Issues Allergy Alert on Undeclared Wheat, Soy, and Sesame in Certain Frozen Olive Flounder Sashimi Products
Eunha Fisheries Co., LTD. Issues Allergy Alert on Undeclared Wheat, Soy, and Sesame in Certain Frozen Olive Flounder Sashimi Products
FDA DrugsSensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30
CGMP Deviations
FDA DevicesMedline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Model Number: DYNJ9855016X
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Model Number: DYNJ9855016X
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
FDA Food6/11oz No Salt Sunflower Seeds
6/11oz No Salt Sunflower Seeds
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
RappelConsola fourche - farine de sarrasin bio 1 kg
la fourche - farine de sarrasin bio 1 kg
une analyse réalisée par notre fournisseur minoterie suire a révélé un dépassement de la norme réglementaire en mycotoxines t2-ht2 sur le lot susmentionné. le résultat obtenu est de 60 ± 11 µg/kg
FDA Food2.0 oz Dirty Maui Onion Chip, Plastic Bag.
2.0 oz Dirty Maui Onion Chip, Plastic Bag.
Potential presence of Salmonella.
FDA FoodJoy Mango-Pina-Orange Lassi 16 oz., 64 oz.
Joy Mango-Pina-Orange Lassi 16 oz., 64 oz.
Product not adequately pasteurized
FDA FoodSpring & Mulberry Earl Grey Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a purple box, UPC 850055470231, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).
Spring & Mulberry Earl Grey Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a purple box, UPC 850055470231, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).
Potential Salmonella contamination
RappelConsofiat professional - grande panda, 600 voiture particulière
fiat professional - grande panda, 600 voiture particulière
il n'y a pas suffisamment de dégagement (< 10 mm) entre le tube du filtre à particules à essence et le capuchon de protection terminal de l'alternateur de démarrage à courroie de 48 v. dans des conditions humides, le manque de dégagement et de contact entre ces composants peut entraîner une infiltration d'eau, provoquant un arc électrique qui peut déclencher un événement thermique, tel qu'une surchauffe. il y a un risque d'incendie.
FDA FoodJoy Mango-Pina-Strawberry Lassi 16 oz.
Joy Mango-Pina-Strawberry Lassi 16 oz.
Product not adequately pasteurized
FDA DevicesSurgify 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).