The Recall Desk
ModerateFDA (Devices)·Z-1907-2021·Announced 2021-06-30

Ultrasonic Probe Covers Recalled for Missing FDA Clearance

Exact Medical Manufacturing is recalling ultrasonic probe covers due to missing FDA 510(k) clearance for use in natural or surgical body openings. The recall affects 8,800 units distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for regulatory non-compliance (missing 510(k) clearance) rather than a documented safety defect or harm. No illnesses or injuries have been reported, making this a precautionary recall.

Plain-English summary

Exact Medical Manufacturing, Inc. is recalling 8,800 units of Probe Cover 6" x 48" ultrasonic transducer covers (Item ID: A-AU-0776NA) in bulk non-sterile packaging.

The product lacks FDA 510(k) premarket clearance for use in natural or surgical body openings. This regulatory deficiency makes the device unapproved for this particular use.

The affected lot numbers are: 1907E366, 1908E436, 1910E101, 1910E444, 1912E463, 2003E605, 2005E438, 2008E091, 2012E096, and 2012E103. The recalled units were distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

The recalled product

Product
Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
Manufacturer
Exact Medical Manufacturing, Inc.
Category
Medical Device — Ultrasound / Imaging Accessories
Hazard
  • regulatory-non-compliance
  • missing-fda-clearance
  • unapproved-use

Distribution

Distributed in 5 states:

  • FL
  • GA
  • MT
  • NY
  • OH

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