Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted… recallZ-0005-05 · CooperSurgical, Inc. · initiated Aug 17, 2004
Terminated All recalls posted in October 2004
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 CooperSurgical, 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
Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System
FDA root cause category: Other
What the company is doing
CooperSurgical telephoned consignees on 8/18/04 and sales representatives to visit the account for removal of recalled product.
Recall details
- Recall number
- Z-0005-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 17, 2004
- Posted by the FDA
- Oct 5, 2004
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 495 units
- Product code
- HDB
- FDA submissions
- K011532
- Distribution
- FL, IA, KS, GA, MA, MN, MS, NE, NY, OH, OK, VA, ME, TX, VA Foreign: Italy
Product description
Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047
Code information (models, lots, serial numbers)
Lot Number: 30115
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
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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