The Recall Desk
HighFDA (Devices)·Z-1918-2021·Announced 2021-06-30

Hays Ultrasound Kit Recalled for Missing FDA Clearance

Exact Medical Manufacturing recalls 10,020 units of Hays Ultrasound Kit (H1000SE) due to lack of FDA 510(k) clearance for use in body openings. The recall affects units in 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: The product is a medical device intended for insertion into body cavities but lacks required FDA 510(k) premarket clearance for this use. No injuries have been reported, but using an uncleared medical device in sensitive body locations represents a risk-of-harm scenario that meets the criteria for High severity.

Plain-English summary

Exact Medical Manufacturing, Inc. is recalling 10,020 units of the Hays Ultrasound Kit (Item ID: H1000SE) due to lack of FDA 510(k) clearance for use in natural or surgical body openings. Affected lot numbers are 2005E090 and 2006E495, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

Using a medical device in body cavities without FDA review and clearance creates a risk of harm. Healthcare providers and facilities should cease using affected units immediately.

Customers should contact Exact Medical Manufacturing, Inc. for information about returning or replacing the recalled devices.

The recalled product

Product
Hays Ultrasound kit Item ID: H1000SE
Manufacturer
Exact Medical Manufacturing, Inc.
Category
Medical Device — Ultrasound / Diagnostic
Hazard
  • uncleared-medical-device
  • regulatory-non-compliance

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: 2005E090 2006E495

Distribution

Distributed in 5 states:

  • FL
  • GA
  • MT
  • NY
  • OH

Related recalls

Same category