The Recall Desk
HighFDA (Devices)·Z-1914-2021·Announced 2021-06-30

Ultrasonic Probe Covers Lack FDA Clearance for Body Use

Exact Medical Manufacturing recalls ultrasonic transducer probe covers marketed without required FDA 510(k) clearance for use in body openings. Approximately 129,600 units distributed to FL, MT, NY, OH, GA, and Puerto Rico.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a medical device marketed without required 510(k) clearance for use in body openings. No reported illnesses or injuries have been documented, making this a risk-of-harm scenario with regulatory non-compliance.

Plain-English summary

Exact Medical Manufacturing, Inc. is recalling Probe Cover Elastic Poly 6" x 48" ultrasonic transducer covers (Item ID: E5322N) due to regulatory non-compliance.

The recalled product was marketed and distributed for use in natural or surgical body openings without the required FDA 510(k) premarket notification clearance. This clearance is required before medical devices can be legally marketed for such uses in the United States.

Approximately 129,600 units were distributed to healthcare facilities in Florida, Montana, New York, Ohio, Georgia, and Puerto Rico, spanning 11 lot numbers from the manufacturing dates specified in the recall notice.

Healthcare providers who have used or possess units from the affected lot numbers should discontinue use and contact Exact Medical Manufacturing for return or replacement instructions.

The recalled product

Product
Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
Manufacturer
Exact Medical Manufacturing, Inc.
Category
Medical Device — Ultrasonic Transducer / Surgical Supplies
Hazard
  • missing-510k-clearance
  • unapproved-body-use

Distribution

Distributed in 5 states:

  • FL
  • GA
  • MT
  • NY
  • OH

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