314-01-02 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Small 10885862084408 314-01-03 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Medium 10885862084415 314-01-04 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Large 10885862084422 314-01-12 GLENOID,KEELED, CEMENTED,Mates with 47, 50, 53 head, beta curvature, Small 10885862084439 314-01-13 GLENOID,KEELED, CEMENTED,Mates with 47, 50, 53…
ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility
Please be aware, this recall is a correction, not a product removal. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Regard Operative Lap P&S Surgical Kit Product Codes: LRO – See Recall Database…
Govvi WOW! contains hidden ingredient
[12-21-2023] The Food and Drug Administration is advising consumers not to purchase or use Govvi WOW!, a product promoted and sold for weight loss on various websites, including www.ebay.com and possibly in some retail stores. FDA laboratory analysis confirmed that Govvi WOW! contains undeclared 1,4-dimethylamylamine (DMAA). The dietary supplement industry often refers to DMAA as…
Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Tracheostomy Care Kit, Dressing Change Kit, and Tracheostomy Care Set Product Codes: NXA, MCY – See Recall Database Entry: Model Numbers: Catalog No. 800 TRACHEOSTOMY…
Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Ivenix Large Volume Pump Product Codes: FRN Model Numbers: LVP-0004 Distribution Dates: October 1, 2021 to July 31, 2023 Devices Recalled in the U.S.: 938…
World Green Nutrition, Inc. is Recalling ELV Alipotec Brand Mexican Tejocote Root Supplement Pieces (Raiz De Tejocote Mexicano Suplemento En Trozos), Net. Wt, 0.3 0Z (7g), Due to the Presence of Yellow Oleander in this Product
Summary Company Announcement Date: January 12, 2024 FDA Publish Date: January 12, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Product contains yellow oleander. Company Name: World Green Nutrition, Inc. Brand Name: Brand Name(s) ELV Alipotec Product Description: Product Description Mexican Tejocte Root Supplement Company Announcement WORLD GREEN NUTRITION, INC. is…
ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: AirFit and AirTouch masks Product Codes: See Recall Database Entries: Model Numbers: AirFit…
Certain Type of Medicines Approved for Type 2 Diabetes and Obesity: Drug Safety Communication – Update on FDA’s Ongoing Evaluation of Reports of Suicidal Thoughts or Actions
[Posted 01/11/2024] AUDIENCE: Patient, Health Professional, Endocrinology, Pharmacy ISSUE: The FDA has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists. These medicines are used to treat people with type 2 diabetes or to help those with obesity or overweight to lose weight. FDA’s…
Wegmans Food Markets, Inc. Issues Allergy Alert on Outrageous Oat Cookies for Undeclared Wheat
Summary Company Announcement Date: January 10, 2024 FDA Publish Date: January 10, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared wheat Company Name: Wegmans Brand Name: Brand Name(s) Product Description: Product Description Outrageous Oat Cookies Company Announcement Rochester, NY – Wegmans has initiated a voluntary recall of Outrageous Oat Cookies…
U.S. Trading Company of Hayward, CA is Recalling Dragonfly Jelly Bars Because it Contains Konjac Powder and May Present a Choking Hazard
Summary Company Announcement Date: January 11, 2024 FDA Publish Date: January 11, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Product contains konjac powder and may present a choking hazard. Company Name: U.S. Trading Company Brand Name: Brand Name(s) Product Description: Product Description Jelly Handbag and Jelly Backpack containing Jelly Bars…