FDA Medical Device Recalls (openFDA)
Wallach Surgical Devices, Inc.: Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X Reference: 900220
- Recall number
- Z-1046-2007
- Recalling firm
- Wallach Surgical Devices, Inc.
- Product
- Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X Reference: 900220
- Status
- Terminated
- Initiated
- 2007-06-06
- Posted
- 2007-07-11
- Terminated
- 2015-07-15
- Reason
- The tip may separate from the probe.
- Root cause
- Device Design
- Action
- Wallach Surgical notified accounts by fax on 6/6/07. A follw-up telephone call will be made to the 70 domestic consignees. Foreign consignees notiifed by fax or email with follow-up telephone calls. Accounts are requested to return product and replace with an alternate product.
- Quantity
- 14 units
- Distribution
- Worldwide, including USA, Canada, Australia, England, Greece, Jordan, Turkey, Hungary, Netherlands, Saudi Arabia, Spain, and Lithuania
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K803311"]
- PMA numbers
- not on file
- Product code
- GEH
- Firm FEI
- 1216677
- Firm city
- Orange
- 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