AHA - American Hospital Association
07/22/2025 | News release | Distributed by Public on 07/22/2025 14:12
Recall issued by FDA for certain craniotomy kits
The Food and Drug Administration has identified a Class I recall of certain lots of Medline Industries Craniotomy Kits containing recalled Codman Disposable Perforators 14mm due to the potential of serious injury or death. The recall was issued due to an inadequate weld that may cause the perforator to come apart before, during or after use in a craniotomy procedure. The recall involves correcting the devices and does not call for them to be removed from where they are used or sold.
Recall Management
Medical Device Safety
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