Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
Showing 24 of 17,563 results
Medical Device
FDA Devices
FDA DevicesSurgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
FDA DevicesClass II
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).
Jul 1, 2026SURGIFY MEDICAL OY
Medical DeviceFDA Devices
FDA DevicesSurgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
FDA DevicesClass II
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).
Jul 1, 2026SURGIFY MEDICAL OY
Food & BeverageFDA Food
FDA FoodSpring & Mulberry Mango Chili Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in an orange box, UPC 850055470033, 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 Inc.
FDA FoodClass I
Spring & Mulberry Mango Chili Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in an orange box, UPC 850055470033, 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
Jul 1, 2026Spring & Mulberry Inc.
Medical DeviceFDA Devices
FDA DevicesConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62858B TAVR JUDKINS PACK DYNJ51127B
Medline Industries, LP
FDA DevicesClass II
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62858B TAVR JUDKINS PACK DYNJ51127B
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Jul 1, 2026Medline Industries, LP
Food & BeverageFDA Food
FDA Food6/11oz No Salt Sunflower Seeds
George J Howe Company, Inc.
FDA FoodClass I
6/11oz No Salt Sunflower Seeds
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Jul 1, 2026George J Howe Company, Inc.
Medical DeviceFDA Devices
FDA DevicesOctopus Evolution AS Tissue Stabilizer, Model TS2500
Medtronic Perfusion Systems
FDA DevicesClass II
Octopus Evolution AS Tissue Stabilizer, Model TS2500
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Jul 1, 2026Medtronic Perfusion Systems
Medical DeviceFDA Devices
FDA DevicesSurgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
FDA DevicesClass II
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Jul 1, 2026SURGIFY MEDICAL OY
Medical DeviceFDA Devices
FDA DevicesAbiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Abiomed, Inc.
FDA DevicesClass I
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.
Jul 1, 2026Abiomed, Inc.
Food & BeverageFDA Food
FDA Foodboichik 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 Bagels, Inc.
FDA FoodClass II
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.
Jul 1, 2026Boichik Bagels, Inc.
Food & BeverageFDA Food
FDA Food5# Sunflower Seeds C/S
George J Howe Company, Inc.
FDA FoodClass I
5# Sunflower Seeds C/S
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Jul 1, 2026George J Howe Company, Inc.
Medical DeviceFDA Devices
FDA DevicesConvenience 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
Medline Industries, LP
FDA DevicesClass II
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.
Jul 1, 2026Medline Industries, LP
Food & BeverageFDA Food
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 Inc.
FDA FoodClass I
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
Jul 1, 2026Spring & Mulberry Inc.
Medical DeviceFDA Devices
FDA DevicesSurgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
FDA DevicesClass II
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).
Jul 1, 2026SURGIFY MEDICAL OY
Food & BeverageFDA Food
FDA Food6/11oz Sunflower Seeds Salted
George J Howe Company, Inc.
FDA FoodClass I
6/11oz Sunflower Seeds Salted
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Jul 1, 2026George J Howe Company, Inc.
PharmaceuticalFDA Drugs
FDA DrugsBD 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.
CareFusion 213, LLC
FDA DrugsClass II
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.
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Jul 1, 2026CareFusion 213, LLC
Medical DeviceFDA Devices
FDA DevicesSurgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
FDA DevicesClass II
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Jul 1, 2026SURGIFY MEDICAL OY
PharmaceuticalFDA Drugs
FDA DrugsBD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
CareFusion 213, LLC
FDA DrugsClass I
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
Non-Sterility: Due to presence of Aspergillus penicillioides.
Jul 1, 2026CareFusion 213, LLC
Medical DeviceFDA Devices
FDA DevicesConvenience 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
Medline Industries, LP
FDA DevicesClass II
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.
Jul 1, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesOctopus 4 Tissue Stabilizer, Model 29400
Medtronic Perfusion Systems
FDA DevicesClass II
Octopus 4 Tissue Stabilizer, Model 29400
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Jul 1, 2026Medtronic Perfusion Systems
PharmaceuticalFDA Drugs
FDA DrugsDULOXETINE 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.
Direct Rx
FDA DrugsClass II
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
Jul 1, 2026Direct Rx
PharmaceuticalFDA Drugs
FDA DrugsSensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30
Amgen, Inc.
FDA DrugsClass II
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30
CGMP Deviations
Jul 1, 2026Amgen, Inc.
Medical DeviceFDA Devices
FDA DevicesSurgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
FDA DevicesClass II
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Jul 1, 2026SURGIFY MEDICAL OY
Food & BeverageFDA Food
FDA FoodSpring & Mulberry Lavender Rose Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a light blue box, UPC 850055470019, 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 Inc.
FDA FoodClass I
Spring & Mulberry Lavender Rose Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a light blue box, UPC 850055470019, 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
Jul 1, 2026Spring & Mulberry Inc.
Medical DeviceFDA Devices
FDA DevicesOff-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Zimmer, Inc.
FDA DevicesClass II
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.
Jul 1, 2026Zimmer, Inc.