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