FDA Medical Device Recalls (openFDA)
Exact Medical Manufacturing, Inc.: Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
- Recall number
- Z-1907-2021
- Recalling firm
- Exact Medical Manufacturing, Inc.
- Product
- Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
- 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
- 8800 units
- Distribution
- US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
- Lot, serial or model codes
- Lot Numbers: 1907E366 1908E436 1910E101 1910E444 1912E463 2003E605 2005E438 2008E091 2012E096 2012E103
- 510(k) numbers
- ["K101689"]
- 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