Summary Company Announcement Date: December 21, 2023 FDA Publish Date: December 22, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Glass Particulate Matter Company Name: Hospira, Inc. Brand Name: Brand Name(s) Product Description: Product Description Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial Company Announcement FOR IMMEDIATE…
ResMed Notifies Customers About Updated Instructions and Labeling for Masks with Magnets Due to Potential Interference with Certain Medical Devices
Summary Company Announcement Date: December 20, 2023 FDA Publish Date: December 21, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for magnetic interference near certain implants and medical devices Company Name: ResMed Brand Name: Brand Name(s) Product Description: Product Description Masks with magnets Company Announcement ResMed’s masks with magnets are safe…
Medline Industries, LP. Issues a Voluntary Nationwide Recall of Various Lots of Tracheostomy Care and Cleaning Trays
Summary Company Announcement Date: December 20, 2023 FDA Publish Date: December 20, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device & Drug Safety – Potential Component Defect Company Name: Medline Industries, LP Brand Name: Brand Name(s) Product Description: Product Description Tracheostomy Care and Cleaning Trays Company Announcement Northfield, Ill., Dec. 20,…
Busse Hospital Disposables Issues Nationwide Recall of Kits/Trays Containing Sterile Water Based Products Under Recall by Nurse Assist
Summary Company Announcement Date: December 19, 2023 FDA Publish Date: December 20, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device & Drug Safety – Potential Lack of Sterility Company Name: Busse Hospital Disposals Brand Name: Brand Name(s) Busse Hospital Disposals Product Description: Product Description Medical Device Kits and Trays Company Announcement…
Medtronic Navigation Inc. Recalls StealthStation S8 Application Version 2.0 and 2.0.1 Due to a Software Glitch
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: StealthStation S8 Application Version 2.0 and 2.0.1 Product Codes: See Recall Database Entry…
InvaGen Pharmaceuticals Issues Voluntary Nationwide Recall of Vigabatrin for Oral Solution, USP 500mg due to Leaking Sachets
Summary Company Announcement Date: December 09, 2023 FDA Publish Date: December 11, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to seal integrity issues allowing for powder leakage from the pouch. Company Name: InvaGen Pharmaceuticals Inc. Brand Name: Brand Name(s) Product Description: Product Description Vigabatrin for Oral Solution, USP 500mg Company Announcement…
Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive
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: CARDIOHELP Emergency Drive Product Codes: See Recall Database Entry Model Numbers: 701048002, 701076205 Manufacturing Dates: August 11, 2022 through June 20, 2023 Distribution Dates: September…
Cardinal Health Issues Medical Device Recall for Nurse Assist Products Contained Within Kits/Trays
Summary Company Announcement Date: December 07, 2023 FDA Publish Date: December 07, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential lack of sterility assurance which could result in non-sterile product Company Name: Cardinal Health Brand Name: Brand Name(s) Covidien and Cardinal Health Product Description: Product Description Urology and OR room specific…
Cordis US Corp Recalls INFINITI Angiographic Catheter due to Products Being Shipped Without Undergoing Sterilization Procedures
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: Cordis INFINITI Angiographic Catheter Product Codes: DQO Lot Number: 18223410 Distribution Dates: August 21, 2023 to September 25, 2023 Devices Recalled in the U.S.: 30…
Antiseizure Medicines Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam): Drug Safety Communication – FDA Warns of Rare but Serious Drug Reaction
[Posted 11/28/2023] AUDIENCE: Patient, Health Professional, Neurology, Dermatology, Allergy and Immunology, Pharmacy ISSUE: The FDA is warning that the antiseizure medicines, Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction…