GE Medical Systems, LLC Sterile, Drape, Headset, Lower, Part Number 888944-01. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sterile, Drape, Headset, Lower, Part Number 888944-01.
Brand
GE Medical Systems, LLC
Lot Codes / Batch Numbers
all lots
Products Sold
all lots
GE Medical Systems, LLC is recalling Sterile, Drape, Headset, Lower, Part Number 888944-01. due to GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could b. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.
Recommended Action
Per FDA guidance
GE Healthcare issued an Urgent Recall Notice dated August 15, 2008. The letter described the problem, provided a list of products, instructed customers to stop using the products and to return or dispose. To receive credit, customers must complete the attached product return form and include it in the package with returned items. All customers were asked to complete and fax back the attached response form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026