Probe Cover (Exact Medical) – 510k Compliance Issue (2021)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
Brand
Exact Medical Manufacturing, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: 1906E228 1907E501 1908E562 1910E027 1910E345 1911E263 1912E541 2003E241 2003E830 2010E342 2011E403
Exact Medical Manufacturing, Inc. is recalling Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N due to No 510k for the product to be used in a natural or surgical opening to the body. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
No 510k for the product to be used in a natural or surgical opening to the body
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, GA, MT, NY, OH, PR
Page updated: Jan 10, 2026