Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used… recallZ-1046-2007 · Wallach Surgical Devices, Inc. · initiated Jun 6, 2007
Terminated All recalls posted in July 2007
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 Wallach Surgical Devices, 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
The tip may separate from the probe.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1046-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 6, 2007
- Posted by the FDA
- Jul 11, 2007
- Recalling firm
- Wallach Surgical Devices, Inc.
- Quantity
- 14 units
- Product code
- GEH
- FDA submissions
- K803311
- Distribution
- Worldwide, including USA, Canada, Australia, England, Greece, Jordan, Turkey, Hungary, Netherlands, Saudi Arabia, Spain, and Lithuania
Product description
Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X Reference: 900220
Code information (models, lots, serial numbers)
All lots
Other devices under the same FDA submission
1 device cleared under K803311 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Wallach 900161Coopersurgical, Inc. · Unit, Cryosurgical, Accessories2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 38072).
- Z-1045-2007 · TerminatedWallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems Reference: 900218
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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