The Recall Desk
HighFDA (Devices)·Z-1919-2021·Announced 2021-06-30

Ultrasound Probe Cover Kit Recalled for Lack of FDA Clearance

Exact Medical Manufacturing is recalling the Hays Innovation Ultrasound Probe Cover Kit because it lacks required FDA 510(k) clearance for use in 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: This is an FDA Class II medical device recall where the product was distributed without required 510(k) premarket clearance for use in natural or surgical body openings. Although no illnesses or injuries have been reported, the regulatory clearance specifically evaluates safety for the intended use, making this a risk-of-harm situation.

Plain-English summary

Exact Medical Manufacturing, Inc. is recalling the Hays Innovation Ultrasound Probe Cover Kit, Item ID HS2000HL, Lot Number 2005E091. The recall involves 3,000 units distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

The product is being recalled because it was marketed without the required FDA 510(k) premarket notification clearance. A 510(k) is required before a Class II medical device may be distributed for use in natural or surgical body openings.

Customers who have obtained this product should discontinue use. They should contact Exact Medical Manufacturing, Inc. regarding the recalled product.

The recalled product

Product
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Manufacturer
Exact Medical Manufacturing, Inc.
Category
Medical Device — Ultrasound Probe Cover
Hazard
  • uncleared-device

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: 2005E091

Distribution

Distributed in 5 states:

  • FL
  • GA
  • MT
  • NY
  • OH

Related recalls

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