Safety Recall Directory
Browse and filter the latest official safety alerts globally.
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.
25# Sunflower Seeds C/S
25# Sunflower Seeds C/S
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Abiomed 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.
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
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
Roast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhesive label. The label reads in part as "***Lunch Box Kitchen*** Premium Convenience***Turkey & Cheddar Sub***BEST BY 06/14/26 Lot no. 26 134 NET WEIGHT: 6.1oz***KEEP REFRIGERATED*** Produced by: Produce Innovations***1845 Colonial Parkway Norwalk, IA 50211***"
Roast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhesive label. The label reads in part as "***Lunch Box Kitchen*** Premium Convenience***Turkey & Cheddar Sub***BEST BY 06/14/26 Lot no. 26 134 NET WEIGHT: 6.1oz***KEEP REFRIGERATED*** Produced by: Produce Innovations***1845 Colonial Parkway Norwalk, IA 50211***"
Incorrect Product Label; Roast Beef and Swiss closed face sub sandwich labeled as Turkey and Cheddar closed face sub sandwich
Joy Pineapple Lassi 16 oz.
Joy Pineapple Lassi 16 oz.
Product not adequately pasteurized
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
la 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
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
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.
8/9.5oz Tub Nut - Sunflower Seed
8/9.5oz Tub Nut - Sunflower Seed
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B
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, 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).
zpare - antirouille et degripant
zpare - antirouille et degripant
le produit, en raison d'un étiquetage de danger non conforme, néglige les risques inhérents à son utilisation
Spring & Mulberry Mint Leaf Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a teal green cardboard box, UPC 850055470217, 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 Mint Leaf Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a teal green cardboard box, UPC 850055470217, 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
5# Sunflower Seeds C/S
5# Sunflower Seeds C/S
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Joy Mint Lassi 16 oz.
Joy Mint Lassi 16 oz.
Product not adequately pasteurized
2.5oz , 8oz , Zapp's Brand Bayou Blackened Ranch Potato Chips, Plastic Bag.
2.5oz , 8oz , Zapp's Brand Bayou Blackened Ranch Potato Chips, Plastic Bag.
Potential presence of Salmonella.
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
Spring & Mulberry Blood Orange Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in an orange box, UPC 850055470200, 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 Blood Orange Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in an orange box, UPC 850055470200, 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
Spring & Mulberry Pecan Date Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a yellow box, UPC 850055470040, 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 Pecan Date Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a yellow box, UPC 850055470040, 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.
Surgify 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).
Chrysler (FCA US, LLC) - Parking & Daytime Running Lights May Fail/FMVSS 108
Chrysler (FCA US, LLC) - Parking & Daytime Running Lights May Fail/FMVSS 108
Parking lights and daytime running lights that fail to illuminate properly reduce the vehicle's visibility to other drivers, increasing the risk of a crash.
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Joy Salty Lassi 16 oz.
Joy Salty Lassi 16 oz.
Product not adequately pasteurized