Tag: class_i_recall

FDA Issues Class I Recall for Abiomed Impella Heart Pump Controllers

22 Jun 2026 11:24 a.m. · Source: US Food and Drug Administration

The FDA has upgraded an alert for Abiomed's Automated Impella Controllers to a Class I recall, the most serious type, following two injuries and one death. The recall focuses on updated usage instructions to prevent serious harm, not device removal.

Health Business Law Enforcement Medical Science Legal Social Issues FDA Abiomed Automated Impella Controllers Class I recall Heart pump Medical device Product Recall Food Recalls Drugs
KayserBetten Issues Urgent Correction for IDA Pediatric Care Beds Amid Serious Injury Risk

30 May 2026 7:07 a.m. · Source: US Food and Drug Administration

KayserBetten is correcting its IDA pediatric care beds due to a serious entrapment risk, identified as a Class I recall. A free hand control replacement with automatic locking will be provided to prevent injury or death.

Health Business Medical Science Legal Social Issues KayserBetten IDA pediatric care beds Product Recall Class I Recall Medical Device Child Safety Entrapment Risk Food Recalls FDA Drugs
FDA Issues Class I Recall for Medline Namic Manifolds Over Serious Health Risks

26 May 2026 1:56 p.m. · Source: US Food and Drug Administration

The FDA has issued a Class I recall for Medline Namic Manifolds and related kits due to particulate in the fluid path. This poses a serious risk of injury or death if introduced into blood circulation, prompting immediate removal of…

Health Business Medical Science Federal Government Legal Product Recall Medline Namic Manifolds FDA Class I Recall Medical Devices Patient Safety Food Recalls Drugs

Tag: class_i_recall

FDA Issues Class I Recall for Abiomed Impella Heart Pump Controllers

KayserBetten Issues Urgent Correction for IDA Pediatric Care Beds Amid Serious Injury Risk

FDA Issues Class I Recall for Medline Namic Manifolds Over Serious Health Risks