Z-1889-2008

Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a...

Name: Z-1889-2008 Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a...
Creator: Cooper Surgical, Inc.
Published: 2008-01-16
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2008-01-16 / Terminated / root cause: design

FDA source

Cooper Surgical, Inc. began a recall of 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... on 2008-01-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1889-2008
Status: Terminated
Initiated: 2008-01-16
Posted: 2008-09-17
Terminated: 2012-05-23
Recalling firm: CooperSurgical, Inc.
Product: 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.
Product code: HDB Extractor, Vacuum, Fetal
Reason for recall: 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 tag: design
FDA 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.
Distribution: Class II Recall - Worldwide Distribution --- including USA and Australia, Canada, Hong Kong, Latin America, Israel, and New Zealand.
Product codes and lots: 57735, 57760, 57761, 57768, 57908, 57909, 57910, 57911, 57912, 57913, 57918, 57919, 57922, 57924, 57925, 58299, and 60815.

Product code HDB

K011532Class IIMityvacPrism Enterprises, Inc. / cleared 2001-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)