Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
Showing 24 of 17,562 results
Medical Device
FDA Devices
FDA DevicesAtellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Siemens Healthcare Diagnostics, Inc.
FDA DevicesClass II
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
Jul 15, 2026Siemens Healthcare Diagnostics, Inc.
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ901348F
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ901348F
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
Jul 15, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesMiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Medtronic MiniMed, Inc.
FDA DevicesClass II
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).
Jul 15, 2026Medtronic MiniMed, Inc.
Medical DeviceFDA Devices
FDA DevicesOlympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
Jul 15, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesBrand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
Elekta, Inc.
FDA DevicesClass II
Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Jul 15, 2026Elekta, Inc.
PharmaceuticalFDA Drugs
FDA DrugsMethohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.
QuVa Pharma, Inc.
FDA DrugsClass II
Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.
Failed Impurities/Degradation Specifications
Jul 15, 2026QuVa Pharma, Inc.
PharmaceuticalFDA Drugs
FDA DrugsBortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01
Reliance Life Sciences Private Limited
FDA DrugsClass II
Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01
Lack of Sterility Assurance
Jul 15, 2026Reliance Life Sciences Private Limited
PharmaceuticalFDA Drugs
FDA DrugsAzacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01
Reliance Life Sciences Private Limited
FDA DrugsClass II
Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01
Lack of Sterility Assurance
Jul 15, 2026Reliance Life Sciences Private Limited
PharmaceuticalFDA Drugs
FDA DrugsPemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01
Reliance Life Sciences Private Limited
FDA DrugsClass II
Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01
Lack of Sterility Assurance
Jul 15, 2026Reliance Life Sciences Private Limited
PharmaceuticalFDA Drugs
FDA DrugsMedline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04
BioMed Laboratories, LLC.
FDA DrugsClass II
Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Jul 15, 2026BioMed Laboratories, LLC.
PharmaceuticalFDA Drugs
FDA DrugsGasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3
Gasco Industrial Corp.
FDA DrugsClass II
Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3
Subpotent drug
Jul 15, 2026Gasco Industrial Corp.
PharmaceuticalFDA Drugs
FDA DrugsDrogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529
Gasco Industrial Corp.
FDA DrugsClass II
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529
Subpotent drug
Jul 15, 2026Gasco Industrial Corp.
PharmaceuticalFDA Drugs
FDA DrugsDrogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924
Gasco Industrial Corp.
FDA DrugsClass II
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924
Subpotent drug
Jul 15, 2026Gasco Industrial Corp.
PharmaceuticalFDA Drugs
FDA DrugsClomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.
Shimoga Chemicals
FDA DrugsClass II
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.
cGMP deviations
Jul 15, 2026Shimoga Chemicals
Medical DeviceFDA Devices
FDA DevicesOmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Integra LifeSciences Corp. (NeuroSciences)
FDA DevicesClass II
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
Jul 15, 2026Integra LifeSciences Corp. (NeuroSciences)
PharmaceuticalFDA Drugs
FDA DrugsPemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01
Reliance Life Sciences Private Limited
FDA DrugsClass II
Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01
Lack of Sterility Assurance
Jul 15, 2026Reliance Life Sciences Private Limited
PharmaceuticalFDA Drugs
FDA DrugsMethohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31
ONESOURCE SPECIALTY PHARMA LIMITED
FDA DrugsClass II
Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31
Failed Impurities/Degradation Specifications
Jul 15, 2026ONESOURCE SPECIALTY PHARMA LIMITED
Food & BeverageFDA Food
FDA FoodJohnny's Salad and Pasta Elegance 5.5 oz (UPC: 0-70381-10014-9) " Johnny's Salad and Pasta Elegance 2.75 oz (UPC: 0-70381-10013-2)
Adams Extract & Spice LLC
FDA FoodClass II
Johnny's Salad and Pasta Elegance 5.5 oz (UPC: 0-70381-10014-9) " Johnny's Salad and Pasta Elegance 2.75 oz (UPC: 0-70381-10013-2)
Undeclared Sesame allergen
Jul 15, 2026Adams Extract & Spice LLC
PharmaceuticalFDA Drugs
FDA DrugsGasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.
Gasco Industrial Corp.
FDA DrugsClass II
Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.
Subpotent drug
Jul 15, 2026Gasco Industrial Corp.
PharmaceuticalFDA Drugs
FDA DrugsDrogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.
Gasco Industrial Corp.
FDA DrugsClass II
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.
Subpotent drug
Jul 15, 2026Gasco Industrial Corp.
PharmaceuticalFDA Drugs
FDA DrugsGasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA
Gasco Industrial Corp.
FDA DrugsClass II
Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA
Subpotent drug
Jul 15, 2026Gasco Industrial Corp.
Food & BeverageFDA Food
FDA FoodHigh Valley Orchard Chocolate Covered Raisins, net wt. 15oz. per package, each case contains 12/15oz. bags. Product is packaged in clear plastic container. UPC on retail container: 0 952348 80170 0. The label of affected product declares: INGREDIENTS: MILK CHOCOLATE (SUGAR, ***WHOLE MILK POWDER, SOY LECITHIN ***RAISINS***CONTAINS MILK AND SOY*** Distributed by Lehi Valley Trading Company of Mesa, AZ.
Lehi Valley Trading Company, Inc
FDA FoodClass I
High Valley Orchard Chocolate Covered Raisins, net wt. 15oz. per package, each case contains 12/15oz. bags. Product is packaged in clear plastic container. UPC on retail container: 0 952348 80170 0. The label of affected product declares: INGREDIENTS: MILK CHOCOLATE (SUGAR, ***WHOLE MILK POWDER, SOY LECITHIN ***RAISINS***CONTAINS MILK AND SOY*** Distributed by Lehi Valley Trading Company of Mesa, AZ.
Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging.
Jul 15, 2026Lehi Valley Trading Company, Inc
Food & BeverageFDA Food
FDA FoodJB Chicken Sknls 35.73#
Adams Extract & Spice LLC
FDA FoodClass I
JB Chicken Sknls 35.73#
Undeclared Sesame allergen
Jul 15, 2026Adams Extract & Spice LLC
Food & BeverageFDA Food
FDA FoodFresh to You Burger Chicken Fillet Deluxe with Bacon, SKU 10303, Net wt. 5.9oz. Product is refrigerated. UPC 1 00000 01030 3. Manufactured by LPK1 Renton, WA. Product was not sold at retail stores and sold only to employees at certain business' breakroom.
Fresh & Ready Foods LLC
FDA FoodClass I
Fresh to You Burger Chicken Fillet Deluxe with Bacon, SKU 10303, Net wt. 5.9oz. Product is refrigerated. UPC 1 00000 01030 3. Manufactured by LPK1 Renton, WA. Product was not sold at retail stores and sold only to employees at certain business' breakroom.
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella.
Jul 15, 2026Fresh & Ready Foods LLC