The Recall Desk
HighFDA (Devices)·Z-3181-2024·Announced 2024-09-25

HAWK Warming Grid recalled for incorrect expiration date

Safeguard US Operating LLC is recalling the HAWK Warming Grid (Item 59-300) due to an incorrect expiration date. The affected units may not function safely if used beyond the actual expiration date.

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 a Class II medical device recall involving incorrect expiration date labeling. The hazard represents a risk-of-harm situation because consumers may rely on incorrect expiration information and use a device beyond its actual safe-use period. No injuries have been reported.

Plain-English summary

Safeguard US Operating LLC is recalling the HAWK Warming Grid, Item Number 59-300, due to an incorrect expiration date on the product label. Approximately 655 units have been affected by this recall.

The incorrect expiration date creates a risk that the device may not function properly or safely if used beyond its actual expiration period. Consumers relying on the printed label for guidance on device safety and effectiveness may unknowingly use an expired device.

The affected units were distributed nationwide across the following states: Alaska, California, Colorado, District of Columbia, Georgia, Illinois, North Carolina, New Mexico, New York, Oklahoma, Oregon, Rhode Island, Texas, Virginia, Washington, and Wisconsin. The affected lot numbers are: PBO0003427, PBO0004028, PBO0004222, PBO0004293, and PBO0004627.

This recall was initiated by Safeguard US Operating LLC and classified as a Class II recall by the FDA.

The recalled product

Product
HAWK Warming Grid, Item Number: 59-300
Manufacturer
Safeguard US Operating LLC
Hazard
  • mis-labeling

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 (6)

  • Item Number: 59-300
  • Lot Numbers: PBO0003427
  • PBO0004028
  • PBO0004222
  • PBO0004293
  • PBO0004627

Distribution

Distributed nationwide across the United States.