FDA Medical Device Recalls (openFDA)
Gebauer Company: Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended for topical application to skin for use in controlling pain associated with injections and the temporary relief of minor sporsts injuries. Rx only- 3.5 fl. oz. (103.5ml) can-Product Number 0386-0004-04
- Recall number
- Z-1058-2007
- Recalling firm
- Gebauer Company
- Product
- Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended for topical application to skin for use in controlling pain associated with injections and the temporary relief of minor sporsts injuries. Rx only- 3.5 fl. oz. (103.5ml) can-Product Number 0386-0004-04
- Status
- Terminated
- Initiated
- 2007-04-17
- Posted
- 2007-07-23
- Terminated
- 2009-11-30
- Reason
- Mold contamination
- Root cause
- Other
- Action
- The firm sent a recall letter dated April 17, 2007 to all customers.
- Quantity
- 21,855 cans of product
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 8019 expires 08-08; 8020 expires 09-08; 8021 expires 10-08 and 8022 expires 12/08
- 510(k) numbers
- ["K031036"]
- PMA numbers
- not on file
- Product code
- MLY
- Firm FEI
- 1519179
- Firm city
- Cleveland
- Firm state
- OH
- 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