FDA Medical Device Recalls (openFDA)
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 number
- Z-1887-2008
- Recalling firm
- Cooper Surgical, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2008-01-16
- Posted
- 2008-09-17
- Terminated
- 2012-05-23
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- not on file
- Distribution
- Class II Recall - Worldwide Distribution --- including USA and Australia, Canada, Hong Kong, Latin America, Israel, and New Zealand.
- Lot, serial or model codes
- 57860, 57861, 57864, 57866, 57868, 57870, 57872, 57873, 57874, 58113, 60728, 60729, 60730 , and 60742.
- 510(k) numbers
- ["K011532"]
- PMA numbers
- not on file
- Product code
- HDB
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28