This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Names: Monitoring Service Application for Mobile…
FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication
[Posted 1/7/2025] AUDIENCE: Patient, Health Care Professional, Pharmacy, Immunology, Pulmonology ISSUE: FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc. and Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) manufactured by GlaxoSmithKline Biologicals. Specifically, FDA has required each manufacturer to include a new warning…
Infusion Pump Battery Recall: ICU Medical Removes Some CSB Batteries Intended For Use With Plum 360, A+, and A+3 Infusion Systems Due to Reports of Allegedly Counterfeit, Untested Batteries In Use
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product and Allegedly Counterfeit Product Product Names: Batteries for use in Plum 360, Plum A+, and…
Early Alert: Fluid Delivery Set Issue from Medline
99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000128741 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000134505 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000133893 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000135769 10193489069587 30193489069581 99000069 FDS, 135, CHMN, W/F, MLL, RC(2), PG 0000139596 10193489069587 30193489069581…
Early Alert: Solution Set Issue from Baxter Healthcare Corporation
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Baxter Healthcare Corporation has…
Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Nuwellis has issued a…
Early Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Olympus has issued a…
Astellas Pharma US, Inc. Issues Voluntary Nationwide Recall of One Lot of PROGRAF® 0.5mg (Tacrolimus) and One Lot of ASTAGRAF XL® 0.5mg (Tacrolimus Extended-Release Capsules) Because Bottles Shipped to U.S. May Contain Empty Capsules
Summary Company Announcement Date: December 23, 2024 FDA Publish Date: December 24, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Bottles may contain empty capsules. Company Name: Astellas Pharma US, Inc. Brand Name: Brand Name(s) Product Description: Product Description Tacrolimus and Tacrolimus Extended-Release capsules Company Announcement FOR IMMEDIATE RELEASE – NORTHBROOK, IL, Dec….
Alcon Laboratories Issues Voluntary Nationwide Recall of One (1) Lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101), Due to Fungal Contamination
Summary Company Announcement Date: December 21, 2024 FDA Publish Date: December 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Fungal Contamination Company Name: Alcon Laboratories Brand Name: Brand Name(s) Product Description: Product Description Lubricant Eye Drugs Company Announcement FOR IMMEDIATE RELEASE – 12/21/2024 – Fort Worth, Texas. Alcon Laboratories is…
Catheter Correction: Boston Scientific Updates Use Instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters due to Higher than Anticipated Number of Reports of Atrio-Esophageal Fistula
This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. Affected Product Product Names:…