CDRH is issuing this Early Alert to notify the public 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 Medline has issued a letter to affected customers recommending all lots of affected…
Early Alert: Portrait Core Services Software Issue from GE HealthCare
CDRH is issuing this Early Alert to notify the public 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 GE HealthCare has issued a letter alerting affected customers of updated use instructions…
Early Alert: Epidural Kit Issue from Medical Action Industries
CDRH is issuing this Early Alert to notify the public 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. The FDA is aware that Medical Action Industries has issued a letter to affected customers recommending certain epidural kits be…
Convenience Kit Recall: Medline Issues Correction for Convenience Kits Containing B. Braun Bupivacaine Hydrochloride Components
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 The FDA is aware that Medline has…
B. Braun Medical Inc. Issues Voluntary North American Recall of Excel® Lactated Ringers Injection, 1000mL Due to the Presence of Particulate Matter
Summary Company Announcement Date: August 19, 2026 FDA Publish Date: August 19, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and polystyrene Company Name: (B. Braun) Brand Name: Brand Name(s) Product Description: Product Description…
Early Alert: Convenience Kit Issue from Becton Dickinson
CDRH is issuing this Early Alert to notify the public 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 Becton Dickinson (BD) has issued a letter to affected customers recommending certain convenience…
Intraosseous Needle Set Recall: Becton Dickinson Removes Certain Intraosseous Vascular Access System Needle Sets
The affected products and recommendations for what to do with the devices below have not changed. 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…
Breathing Circuit Set Recall: Hamilton Medical Removes Breathing Circuit Set
The recommendations provided below have changed. 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 The FDA is aware that Hamilton Medical has issued…
Update on Alert: Convenience Kit Issue from Medline
CDRH is issuing this Early Alert to notify the public 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 lots have been added to the Excel sheet in the Affected Product section. Affected Product The FDA is aware that…
Intravascular Administration Set Recall: Baxter Removes Duo-Vent Solution Sets
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. The affected products and recommendations for what to do with the devices below have not changed. Affected…