The Recall Desk
HighFDA (Devices)·Z-0015-2023·Announced 2022-10-19

Hobbs Medical Polypectomy Snare recalled for incorrect expiration date on label

Hobbs Medical is recalling its Polypectomy Snare for an incorrect expiration date on the label that extends shelf life. Affected devices were distributed in the US and other countries from March 2018 to September 2020.

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 Class II recall involves a labeling error that could lead to use of devices beyond their actual safe period. No illnesses or injuries have been reported. The risk is theoretical, meeting the Score 3 criterion for risk-of-harm products without reported injury.

Plain-English summary

Hobbs Medical, Inc. is recalling its Polypectomy Snare (Catalog Number 4563) because the device label displays an incorrect expiration date that extends the shelf life beyond the actual safe period.

The affected product was distributed in the United States and to Canada, Austria, Belgium, Finland, and Norway between March 25, 2018, and September 28, 2020. Approximately 100 units are involved. Recalled devices have lot numbers ending in 'R'—including H03-16-067R, H09-15-146R, H10-15-086R, and H12-15-100R—or are kits containing at least one device with such a lot number. Affected devices carry expiration dates between November 1, 2022, and September 1, 2025.

The recalled product

Product
Hobbs Medical Polypectomy Snare Catalog Number: 4563
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Endoscopy Equipment
Hazard
  • expiration-date-error

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)

  • UDI-DI: M84945630 Lot Numbers: H03-16-067R H09-15-146R H10-15-086R H12-15-100R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category