Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Showing 24 of 74,115 results
Medical Device
FDA Devices
FDA DevicesBrand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.
Elekta, Inc.
FDA DevicesClass II
Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.
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.
Medical DeviceFDA Devices
FDA Devices5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.
Fresenius Medical Care Holdings, Inc.
FDA DevicesClass II
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Jul 15, 2026Fresenius Medical Care Holdings, Inc.
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.
Medical DeviceFDA 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) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A
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 DevicesBrand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.
CMR SURGICAL LIMITED
FDA DevicesClass II
Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Jul 15, 2026CMR SURGICAL LIMITED
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 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.
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.
Food & Beverage
RappelConso
RappelConsofait maison - céleri remoulade
fait maison
RappelConsovolontaire (san...
fait maison - céleri remoulade
présence de corps étrangers
Jul 15, 2026fait maison
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 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 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
Safety Alert
Australia Products
Australia ProductsGalmet ColdGal Brushable Paint
Unknown Firm
Australia ProductsGarden tools an...
Galmet ColdGal Brushable Paint
The container may bulge or swell due to internal pressure build up. Contents can be expelled when the container is opened.
Jul 15, 2026
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 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 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 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 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
Food & BeverageRappelConso
RappelConsobaraenn - pain de mie graines bénéfiques chia, lin brun, courges
baraenn
RappelConsovolontaire (san...
baraenn - pain de mie graines bénéfiques chia, lin brun, courges
teneur en acide cyanhydrique supérieure à la réglementation
Jul 15, 2026baraenn
Food & BeverageRappelConso
RappelConsopinabel - protein mie
pinabel
RappelConsovolontaire (san...
pinabel - protein mie
teneur en acide cyanhydrique supérieure à la réglementation
Jul 15, 2026pinabel
Food & BeverageRappelConso
RappelConsopinabel - pain de mie graines magiques lin, courge et chia
pinabel
RappelConsovolontaire (san...
pinabel - pain de mie graines magiques lin, courge et chia
teneur en acide cyanhydrique supérieure à la réglementation
Jul 15, 2026pinabel
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.