Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery… recallZ-1889-2008 · Cooper Surgical, Inc. · initiated Jan 16, 2008
Terminated All recalls posted in September 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cooper Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1889-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 16, 2008
- Posted by the FDA
- Sep 17, 2008
- Recalling firm
- Cooper Surgical, Inc.
- Product code
- HDB
- FDA submissions
- K011532
- Distribution
- Class II Recall - Worldwide Distribution --- including USA and Australia, Canada, Hong Kong, Latin America, Israel, and New Zealand.
Product description
Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections.
Code information (models, lots, serial numbers)
57735, 57760, 57761, 57768, 57908, 57909, 57910, 57911, 57912, 57913, 57918, 57919, 57922, 57924, 57925, 58299, and 60815.
Other devices under the same FDA submission
2 devices cleared under K011532 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Mystic 10057Coopersurgical, Inc. · Extractor, Vacuum, Fetal19 reports
- Mityvac 10004Coopersurgical, Inc. · Extractor, Vacuum, Fetal1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 46377).
- Z-1887-2008 · TerminatedM-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…
- Z-1888-2008 · TerminatedM-Style Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum Assisted Delivery System (Ref: 10015LP). Product is intended to assist a clinician in the delivery o…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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