FDA Medical Device Recalls (openFDA)
Marina Medical Instruments Inc.: VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100, VNVD Veronikis Neo Vaginal Dilator - 1.5cm Tip:Width:0.625in Catalog No. 270-115 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 2.5cm Tip:Width:0.625in Catalog No. 270-125 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 3.5cm Tip:Width:0.625in Catalog No. 270-135 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 4.5cm Tip:Width:0.625in Catalog No. 270-145 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 5.5cm Tip:Width:0.625in Catalog No. 270-155 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Partial Taper Couple: Width:0.625in - 1in Catalog No. 270-165 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Full Taper Couple: Width:0.625in - 1in Catalog No. 270-175 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Coupler 3cm Length: Width: 1in Catalog No. 270-185 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Small Base, Screw Length 2cm Tip: Width: 1in Catalog No. 270-195 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 1.5cn Tip: Width:0.625in Catalog No. 270-199 (sold individually). For use in securing open the opening during examination of the vaginal body cavity. For the Non-Surgical Neo Vagina.
- Recall number
- Z-1208-2010
- Recalling firm
- Marina Medical Instruments Inc.
- Product
- VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100, VNVD Veronikis Neo Vaginal Dilator - 1.5cm Tip:Width:0.625in Catalog No. 270-115 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 2.5cm Tip:Width:0.625in Catalog No. 270-125 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 3.5cm Tip:Width:0.625in Catalog No. 270-135 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 4.5cm Tip:Width:0.625in Catalog No. 270-145 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 5.5cm Tip:Width:0.625in Catalog No. 270-155 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Partial Taper Couple: Width:0.625in - 1in Catalog No. 270-165 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Full Taper Couple: Width:0.625in - 1in Catalog No. 270-175 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Coupler 3cm Length: Width: 1in Catalog No. 270-185 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Small Base, Screw Length 2cm Tip: Width: 1in Catalog No. 270-195 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 1.5cn Tip: Width:0.625in Catalog No. 270-199 (sold individually). For use in securing open the opening during examination of the vaginal body cavity. For the Non-Surgical Neo Vagina.
- Status
- Terminated
- Initiated
- 2009-04-09
- Posted
- 2010-03-25
- Terminated
- 2010-09-03
- Reason
- Marina Medical, Sunrise, FL initiated recall of 46 products of 350 series devices and 47 products of 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.
- Root cause
- Nonconforming Material/Component
- Action
- A "PRODUCT RECALL NOTICE" letter dated April 8, 2009, was sent to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers are asked to identify the subject part in their instrument inventory and quarantine it. The Quality Control team at Marina Medical will contact the customer with instructions to return the part. When contacted, the customer should report any incidents of adverse reactions that have been observed at their institution. If you have any questions, please call 1-800-697-1119 ore (954) 924-4418.
- Quantity
- 22
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Product No.: 270-100, 270-115, 270-125, 270-135, 270-145, 270-155, 270-165, 270-175, 270-185, 270-195, 270-199.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HDQ
- Firm FEI
- 1000124817
- Firm city
- Sunrise
- Firm state
- FL
- 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