The Recall Desk
HighFDA (Devices)·Z-1915-2021·Announced 2021-06-30

Transducer Covers Recalled for Missing FDA 510(k) Clearance

Exact Medical Manufacturing is recalling 100,600 transducer covers distributed across six states because they lack required FDA 510(k) clearance for use in natural or surgical body openings.

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 device lacking required 510(k) clearance for use in natural or surgical body openings represents a risk-of-harm product with no reported injuries, matching the 'High' severity criterion.

Plain-English summary

Exact Medical Manufacturing, Inc. is recalling 100,600 units of Transducer Cover 15x147cm kits that include VIP Film with bands and EMM Gel (Item ID: E6359). The product was distributed in Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

The recall was initiated because the product lacks the required FDA 510(k) clearance for its intended use in natural or surgical openings to the body. This regulatory clearance is required to ensure the device meets FDA safety and effectiveness standards for this application.

If you have purchased this product, contact Exact Medical Manufacturing, Inc. for instructions on return or disposal. Affected lot numbers include 2003E690, 2006E079, 2004E015, 2007E001, 2007E002, 2010E361, 2101E329, and 2011E271.

The recalled product

Product
Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
Manufacturer
Exact Medical Manufacturing, Inc.
Category
Medical Device — Ultrasound Equipment
Hazard
  • missing-510k-clearance
  • unapproved-for-use

Distribution

Distributed in 5 states:

  • FL
  • GA
  • MT
  • NY
  • OH

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