Summary Company Announcement Date: April 05, 2024 FDA Publish Date: April 08, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description The potential for a lack of sterility Company Name: Medline Industries, LP Brand Name: Brand Name(s) Medline and Centurion Product Description: Product Description Convenience kits Company Announcement Northfield, Ill., Apr. 5, 2024…
Medos International Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft
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: CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: GS9070SD; GS9080SD; GS9090SD; GS9095SD; Neurovascular guide catheter, single-use Product Codes: QJP Manufacturing Dates: July 7,…
Honeywell Safety Products USA, Inc. Issues Voluntary Worldwide Recall of Honeywell Fendall 2000 Non-Sterile Eyewash Cartridges # 32-002050-0000 used with the Fendall 2000 Eyewash Station Due to a Lack of Appropriate Policies and Procedures by Honeywell’s Supplier
Summary Company Announcement Date: April 04, 2024 FDA Publish Date: April 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Non-compliance with current good manufacturing practice (cGMP) requirements. Company Name: Honeywell Safety Products USA Brand Name: Brand Name(s) Fendall 2000 Product Description: Product Description Non-Sterile Eyewash Cartridge Company Announcement FOR IMMEDIATE RELEASE –…
Aruba Aloe Balm N.V. Issues Voluntary Nationwide Recall of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel Due to Presence of Methanol
Summary Company Announcement Date: April 05, 2024 FDA Publish Date: April 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains methanol Company Name: Aruba Aloe Balm N.V. Brand Name: Brand Name(s) Aruba Aloe Product Description: Product Description Hand Sanitizer Gel and Alcoholada Gel Company Announcement FOR IMMEDIATE RELEASE – April 5th,…
Smiths Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator Kits for a Malfunction Causing Non-Cycling, Continuous Positive Gas Flow and Preventing Proper Ventilation
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 Name: Smiths Medical ASD PneuPac paraPAC Plus 300 and 310 Ventilator Kits Product Models…
Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage
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 Name: ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits Product Codes: See Recall Database Entry Devices Recalled in the U.S.: 334,995 Dates Distributed: December…
AvKARE, LLC. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5 mL Due to Potential Bacillus Cereus Contamination
Summary Company Announcement Date: April 01, 2024 FDA Publish Date: April 01, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Bacillus cereus contamination Company Name: AvKARE, LLC Brand Name: Brand Name(s) Product Description: Product Description Atovaquone Oral Suspension, USP 750mg/5mL Company Announcement FOR IMMEDIATE RELEASE – 3/29/2024 –AvKARE, LLC. is voluntarily recalling…
Amneal Pharmaceuticals, LLC. Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, Due to the Potential for Some Bottles to be Super Potent Which May be Harmful
Summary Company Announcement Date: March 27, 2024 FDA Publish Date: March 27, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potent due to bottles being overfilled Company Name: Amneal Pharmaceuticals, LLC. Brand Name: Brand Name(s) Product Description: Product Description Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL Company Announcement FOR IMMEDIATE RELEASE…
Eugia US LLC (f/k/a AuroMedics Pharma LLC) Issues Voluntary Nationwide Recall of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) Due to Presence of White Particles
Summary Company Announcement Date: March 28, 2024 FDA Publish Date: March 28, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Presence of Particulate Matter Company Name: Eugia US LLC Brand Name: Brand Name(s) Eugia US LLC Product Description: Product Description Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single…
Medline Industries Recalls Certain Kits and Trays Containing Sterile Water Based Products Under Recall by Nurse Assist
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: Medline Kits and Trays Distribution Dates: November 1, 2021 to November 10, 2023…