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Sizing Catheter Recall: Cook Medical Removes Various Centimeter Sizing Catheters
When the sizing catheters are used during angiographic procedures the marker bands may be at an increased risk of cracking/breakage.
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Surgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads
Certain SureForm Surgical Stapler reloads may form incomplete staple lines, leading to severe bleeding or death.
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FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
http://www.fda.gov/news-events/press-announcements/fda-permits-expanded-access-investigational-pancreatic-cancer-drug
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FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia
FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia
http://www.fda.gov/news-events/press-announcements/fda-approves-first-non-antipsychotic-drug-treat-agitation-associated-dementia
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FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
http://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list
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Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods
Omnipod Pods may not deliver insulin as intended due to a tear in the internal tubing.
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FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.
FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.
http://www.fda.gov/news-events/press-announcements/fda-releases-results-largest-ever-testing-infant-formula-us
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FDA Announces Major Steps to Implement Real-Time Clinical Trials
FDA Announces Major Steps to Implement Real-Time Clinical Trials
http://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials
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Early Alert: Thoracic Stent Graft Issue from Bolton Medical
Affected grafts may not unclasp from the delivery system, which may require conversion to open surgical repair and can result in patient death
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B. Braun Medical, Inc. Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection, 1L, E7500 Due to the Presence of Particulate Matter in Solution
For Immediate Release – BETHLEHEM, PA – APRIL 28, 2026 – B. Braun Medical Inc. is voluntarily recalling two lots of Lactated Ringer’s Injection, E7500, 1L, to the hospital/healthcare facility level. The product has been found to have particulate matter in solution.
