Safety Recall Directory
Browse and filter the latest official safety alerts globally.
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.
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.
FDA FoodWellsley Farms Farm- Raised Atlantic Salmon Net WT. 32 oz. (2 lbs.) 907 g
Wellsley Farms Farm- Raised Atlantic Salmon Net WT. 32 oz. (2 lbs.) 907 g
Contaminated with Listeria monocytogenes
FDA FoodIQF Blueberry (30lbs. cases and 1400 lbs. totes), product of USA. Product is packaged in polyethylene bag within a corrugated 30lbs. case or packaged in polyethylene liner within a Gaylord 1400lbs. tote. Product was not sold to consumers from retail stores. Willamette Valley Fruit Company 2994 82nd Ave. NE Salem OR 97305
IQF Blueberry (30lbs. cases and 1400 lbs. totes), product of USA. Product is packaged in polyethylene bag within a corrugated 30lbs. case or packaged in polyethylene liner within a Gaylord 1400lbs. tote. Product was not sold to consumers from retail stores. Willamette Valley Fruit Company 2994 82nd Ave. NE Salem OR 97305
Listeria monocytogenes
FDA DevicesOlympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
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.
FDA DevicesBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Knee and Humeral socket implants contain incorrect labeling.
FDA DevicesConvenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
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.
FDA DevicesOlympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
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.
FDA FoodFish Ball, Frozen, 4 pieces per pack, 5lbs Wt. UPC# 810093891320
Fish Ball, Frozen, 4 pieces per pack, 5lbs Wt. UPC# 810093891320
Undeclared allergen ingredient (Wheat and Sesame)
FDA FoodYoyo Gummy Grape Plus Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
Yoyo Gummy Grape Plus Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
FDA FoodValley Springs 100% Natural Bottled Water. Fluoride Added. 1 Gal Net, 128 Fl. Oz. UPC 0 31193-01301 0. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901.
Valley Springs 100% Natural Bottled Water. Fluoride Added. 1 Gal Net, 128 Fl. Oz. UPC 0 31193-01301 0. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901.
Water was bottled under insanitary conditions.
FDA FoodFish Ball, Frozen, 40 pieces per pack, 200g Wt. UPC# 810093891338
Fish Ball, Frozen, 40 pieces per pack, 200g Wt. UPC# 810093891338
Undeclared allergen ingredient (Wheat and Sesame)
FDA DevicesCampy CVA Medium 100/PK, R01272
Campy CVA Medium 100/PK, R01272
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
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.
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.
FDA DevicesBrand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Software anomaly in the patient positioning system may result in positional discrepancy.
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 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
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 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
FDA DevicesOlympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
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.
FDA DevicesMedline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
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.
FDA FoodYoyo Gummy Assorted Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
Yoyo Gummy Assorted Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
FDA DevicesMedline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
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.
FDA DevicesOlympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
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.
FDA DevicesPIE Trolley System Model: 2005
PIE Trolley System Model: 2005
Lack of 510K clearance
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
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.
FDA DrugsCHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.