Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Showing 24 of 74,116 results
Medical Device
FDA Devices
FDA DevicesOlympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
Food & BeverageFDA Food
FDA FoodTiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel. Net wt: Approx: 2 oz (57g). UPC 8 55725 00514 0. Taste of Maui Snacks dba of J2C Hawaii, LLC PO Box 1023, Wailuku HI 96793. The product label is read in parts: ***INGREDIENTS: Sugar***Whey Powder, Nonfat Milk Powder, Soy Lecithin***Peanut Butter (peanuts, peanut oil***), Pretzels (wheat flour***buttermilk solids***CONTAINS MILK AND SOY ***May contain wheat, peanuts and tree nuts***"
J2C Hawaii LLC
FDA FoodClass II
Tiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel. Net wt: Approx: 2 oz (57g). UPC 8 55725 00514 0. Taste of Maui Snacks dba of J2C Hawaii, LLC PO Box 1023, Wailuku HI 96793. The product label is read in parts: ***INGREDIENTS: Sugar***Whey Powder, Nonfat Milk Powder, Soy Lecithin***Peanut Butter (peanuts, peanut oil***), Pretzels (wheat flour***buttermilk solids***CONTAINS MILK AND SOY ***May contain wheat, peanuts and tree nuts***"
Ingredients List declares peanut but the Contains statement does not declare peanut
Mar 4, 2026J2C Hawaii LLC
Medical DeviceFDA Devices
FDA DevicesMedline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
Medline Industries, LP
FDA DevicesClass II
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Mar 4, 2026Medline Industries, LP
PharmaceuticalFDA Drugs
FDA DrugsVista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
Medical DeviceFDA Devices
FDA DevicesOctopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Medtronic Perfusion Systems
FDA DevicesClass II
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
During the manufacturing, 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.
Mar 4, 2026Medtronic Perfusion Systems
Medical DeviceFDA Devices
FDA DevicesMeijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7
Medline Industries, LP
FDA DevicesClass II
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Mar 4, 2026Medline Industries, LP
Food & BeverageFDA Food
FDA FoodYO!MAN CUCUMBER (FRESH HUNAN FLAVOR); Ingredients: Cucumber, chili pepper, edible vegetable oil, salt, water, sugar, brewing vinegar, food additives (monosodium glutamate, sodium dehydroacetate, potassium sorbate, streptoccoccus lactis, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, xanthan gum), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 10 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529602
TENGEN USA TRADING CORP
FDA FoodClass III
YO!MAN CUCUMBER (FRESH HUNAN FLAVOR); Ingredients: Cucumber, chili pepper, edible vegetable oil, salt, water, sugar, brewing vinegar, food additives (monosodium glutamate, sodium dehydroacetate, potassium sorbate, streptoccoccus lactis, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, xanthan gum), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 10 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529602
Product contains undeclared cyclamates.
Mar 4, 2026TENGEN USA TRADING CORP
Medical DeviceFDA Devices
FDA DevicesConvenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741
Medline Industries, LP
FDA DevicesClass II
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Mar 4, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesOlympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesOlympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesOlympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
PharmaceuticalFDA Drugs
FDA DrugsEptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Slate Run Pharmaceuticals
FDA DrugsClass III
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Mar 4, 2026Slate Run Pharmaceuticals
Food & BeverageFDA Food
FDA FoodYO!MAN LETTUCE (SPICY FLAVOR); Ingredients: Lettuce, chili pepper, edible vegetable oil, salt, water, sugar, food additives (monosodium glutamate, potassium sorbate, streptoccoccus lactis, sodium dehydroacetate, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, sucralose, xanthan gum, disodium 5'flavoring ribonucleotide), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 9 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529626
TENGEN USA TRADING CORP
FDA FoodClass III
YO!MAN LETTUCE (SPICY FLAVOR); Ingredients: Lettuce, chili pepper, edible vegetable oil, salt, water, sugar, food additives (monosodium glutamate, potassium sorbate, streptoccoccus lactis, sodium dehydroacetate, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, sucralose, xanthan gum, disodium 5'flavoring ribonucleotide), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 9 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529626
Product contains undeclared cyclamates.
Mar 4, 2026TENGEN USA TRADING CORP
Medical DeviceFDA Devices
FDA DevicesOlympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesOlympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
PharmaceuticalFDA Drugs
FDA DrugsVista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
PharmaceuticalFDA Drugs
FDA DrugsBioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
Medical DeviceFDA Devices
FDA DevicesBrand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
FDA DevicesClass II
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Software anomaly in the patient positioning system may result in positional discrepancy.
Mar 4, 2026Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Safety Alert
Health Canada
Health CanadaImportation of US-Authorized Vasopressin Injection, USP, 20 units/mL (For IV Infusion) Due to the Current Shortage of Canadian-Authorized Vasopressin Injection, USP, 20 units/mL (For IM or SC Administration)
Marketed health products
Health CanadaGeneral Alert
Importation of US-Authorized Vasopressin Injection, USP, 20 units/mL (For IV Infusion) Due to the Current Shortage of Canadian-Authorized Vasopressin Injection, USP, 20 units/mL (For IM or SC Administration)
Product safety - Packaging - Supply
Mar 4, 2026Marketed health products
PharmaceuticalFDA Drugs
FDA DrugsAgebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0
Agebox
FDA DrugsClass II
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Mar 4, 2026Agebox
PharmaceuticalFDA Drugs
FDA DrugsBio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Mar 4, 2026Medline Industries, LP
PharmaceuticalFDA Drugs
FDA DrugsVista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
Medical DeviceFDA Devices
FDA DevicesMedline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
Medline Industries, LP
FDA DevicesClass II
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Mar 4, 2026Medline Industries, LP