Cooper Surgical, Inc. M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections.
Brand
Cooper Surgical, Inc.
Lot Codes / Batch Numbers
57860, 57861, 57864, 57866, 57868, 57870, 57872, 57873, 57874, 58113, 60728, 60729, 60730, and 60742.
Products Sold
57860, 57861, 57864, 57866, 57868, 57870, 57872, 57873, 57874, 58113, 60728, 60729, 60730 , and 60742.
Cooper Surgical, Inc. is recalling M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). Product due to Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and r. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for delivery. An inability to remove the cup from the head may delay delivery and/or prevent the user from applying forceps if necessary. This may result in serious injury or death to the baby.
Recommended Action
Per FDA guidance
On 1/16/08 Cooper Surgical issued an Urgent Notice of Recall via Fed Ex for USA destinations and via e-mail and facsimile for international destinations, and firm confirmed receipt. The letter requests that accounts return recalled product. The recall was extended to three additional lots, and an Urgent Recall Notice dated 3/18/08 was issued. If you have any questions contact Thomas Williams at (203) 601-4741.
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