Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
Showing 24 of 17,563 results
Medical Device
FDA Devices
FDA DevicesMedline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
Medline Industries, LP
FDA DevicesClass II
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
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. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological 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 DevicesAdapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure
Agiliti Health - Ellis
FDA DevicesClass II
Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure
Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function.
Mar 4, 2026Agiliti Health - Ellis
Food & BeverageFDA Food
FDA FoodValley Springs 100% Natural Bottled Water packaged in the following size plastic jug with plastic caps: 1. 1 Gal Net 128 Fl oz. UPC 0 31193-00701 9. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 2. 2.5 Gallon Net (320 Fl oz./9.4L). UPC 0 31193-01501 4. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 3. Infant Water, 1 Gal Net, 128 FL. Oz. Not sterile. Use as directed by physician or by labeling directions for use of infant formula. UPC 0 31193-01401 7. 4. Daisy's Doggy Water, 1 Gal Net, 128 FL. Oz. 100% Pure Water. No Chlorine. UPC 0 31193-90100 3. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. Distributed by DDW LLC, 109 S. Thompson Rd., Sun Prairie, WI 53590.
Valley Springs Artesian Gold, LLC
FDA FoodClass II
Valley Springs 100% Natural Bottled Water packaged in the following size plastic jug with plastic caps: 1. 1 Gal Net 128 Fl oz. UPC 0 31193-00701 9. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 2. 2.5 Gallon Net (320 Fl oz./9.4L). UPC 0 31193-01501 4. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 3. Infant Water, 1 Gal Net, 128 FL. Oz. Not sterile. Use as directed by physician or by labeling directions for use of infant formula. UPC 0 31193-01401 7. 4. Daisy's Doggy Water, 1 Gal Net, 128 FL. Oz. 100% Pure Water. No Chlorine. UPC 0 31193-90100 3. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. Distributed by DDW LLC, 109 S. Thompson Rd., Sun Prairie, WI 53590.
Water was bottled under insanitary conditions.
Mar 4, 2026Valley Springs Artesian Gold, LLC
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 DevicesMRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light
MRIMed Inc.
FDA DevicesClass II
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
Mar 4, 2026MRIMed Inc.
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
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
Medical DeviceFDA Devices
FDA DevicesOlympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological 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 Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological 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
Medical DeviceFDA Devices
FDA DevicesOlympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Sheath; Model No. A2666. 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 Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological 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 Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. 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 Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
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 DevicesOlympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological 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 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
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
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
Medical DeviceFDA Devices
FDA DevicesOlympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
PharmaceuticalFDA Drugs
FDA DrugsAdbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,
LEO PHARMA INC
FDA DrugsClass II
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Mar 4, 2026LEO PHARMA INC
Medical DeviceFDA Devices
FDA DevicesBrand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
FDA DevicesClass II
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Software anomaly in the patient positioning system may result in positional discrepancy.
Mar 4, 2026Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Food & BeverageFDA Food
FDA FoodPrime Food Processing Dried Croaker Fish; NET WT: 8oz (227g); Ingredients: Croaker Fish, Salt; CONTAINS: FISH (CROAKER FISH); DISTRIBUTED BY: PFP LLC, Brooklyn, NY, 11211, USA; Product must be thoroughly cleaned and cooked before consumption.; PRODUCT OF VIETNAM; UPC: 6 946976 818000
Prime Food Processing LLC.
FDA FoodClass I
Prime Food Processing Dried Croaker Fish; NET WT: 8oz (227g); Ingredients: Croaker Fish, Salt; CONTAINS: FISH (CROAKER FISH); DISTRIBUTED BY: PFP LLC, Brooklyn, NY, 11211, USA; Product must be thoroughly cleaned and cooked before consumption.; PRODUCT OF VIETNAM; UPC: 6 946976 818000
Uneviscerated Fish
Mar 4, 2026Prime Food Processing LLC.
Medical DeviceFDA Devices
FDA DevicesOlympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. 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