FDA Medical Device Recalls (openFDA)
Sandhill Scientific, Inc: Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.
- Recall number
- Z-0359-06
- Recalling firm
- Sandhill Scientific, Inc
- Product
- Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.
- Status
- Terminated
- Initiated
- 2005-12-13
- Posted
- 2006-01-06
- Terminated
- 2006-05-15
- Reason
- Labeling does not indicate that the product contains latex.
- Root cause
- Other
- Action
- All consignees were notified by letter on 12/3/05. Canadian consignees were re-notified on December 14, 2005 by letter.
- Quantity
- 2358 Probes
- Distribution
- Distributed nationwide including PR. Military distibution in MD and TX. Veteran Affairs facilities located in AR, CO, CT, HI, and NC. Foreign distribution includesTaiwan, Saudi Arabia, England, Malaysia, Korea, Chile, Venequela, China, and Brazil.
- Lot, serial or model codes
- All replacement balloons. For use on probe models AB1, PB1, A86-1067, A86-1067-1, A86-5067, A86-5070 and A86-5050.
- 510(k) numbers
- ["K931175"]
- PMA numbers
- not on file
- Product code
- FAP
- Firm FEI
- 2023374
- Firm city
- Highlands Ranch
- Firm state
- CO
- 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