FDA Medical Device Recalls (openFDA)
Exact Medical Manufacturing, Inc.: Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
- Recall number
- Z-1920-2021
- Recalling firm
- Exact Medical Manufacturing, Inc.
- Product
- Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
- Status
- Terminated
- Initiated
- 2021-04-29
- Posted
- not on file
- Terminated
- 2022-05-26
- Reason
- No 510k for the product to be used in a natural or surgical opening to the body
- Root cause
- No Marketing Application
- Action
- Exact Medical issued Correction Notification via email on 4/29/21. Letter states: Exact Medical Manufacturing Ultrasonic Transducer Cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not to be used in a natural or surgical opening to the body. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackers/relabelers establishments for further packaging and ethylene oxide sterilization. These are the boundaries and limitations of use for existing Probe/Transducer cover products in any existing stock from Exact Medical Manufacturing, Inc Further instructions will be given at a future date and we encourage you to reach out with any questions or concerns regarding this issue.
- Quantity
- 78000 units
- Distribution
- US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
- Lot, serial or model codes
- Lot Numbers: 1909E197 1910E296 1911E050 2002E180 2004E028
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 3008011779
- Firm city
- Lancaster
- Firm state
- NY
- 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