Z-0005-05

Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047

Name: Z-0005-05 Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047
Creator: CooperSurgical, Inc.
Published: 2004-08-17
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2004-08-17 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047 on 2004-08-17. The reason FDA records is "Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0005-05
Status: Terminated
Initiated: 2004-08-17
Posted: 2004-10-05
Terminated: 2012-05-10
Recalling firm: CooperSurgical, Inc.
Product: Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047
Product code: HDB Extractor, Vacuum, Fetal
Reason for recall: Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System
Root cause tag: labeling and UDI
FDA root cause: Other
Action: CooperSurgical telephoned consignees on 8/18/04 and sales representatives to visit the account for removal of recalled product.
Quantity in commerce: 495 units
Distribution: FL, IA, KS, GA, MA, MN, MS, NE, NY, OH, OK, VA, ME, TX, VA Foreign: Italy
Product codes and lots: Lot Number: 30115

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)