The Recall Desk
HighFDA (Devices)·Z-0070-2023·Announced 2022-10-19

Hobbs Medical Polypectomy Snare Incorrect Expiration Date Label Recall

Hobbs Medical polypectomy snares have incorrect expiration dates on labels that extend the device shelf life beyond safe limits. Affected products distributed from March 2018 to September 2020 may be used past their intended expiration.

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: FDA Class II medical device recall involving a labeling defect that extends shelf life beyond intended limits. Although no illnesses or injuries have been reported, incorrect expiration dates on medical devices create a risk-of-harm situation where expired or degraded devices may be used in clinical procedures.

Plain-English summary

Hobbs Medical, Inc. is recalling Polypectomy Snares (Catalog Number 4575-OLY) due to incorrect expiration dates displayed on product labels. The incorrect dates extend the shelf life of the product, potentially allowing devices to be used after they have degraded.

Affected devices were distributed in the United States, Canada, Austria, Belgium, Finland, and Norway between March 25, 2018 and September 28, 2020. Products bearing expiration dates between November 1, 2022 and September 1, 2025 are included in this recall. The recalled devices are identified by lot numbers ending in 'R' or kits containing at least one device with such a lot number. The product UDI-DI is M8494575OLY0, and the affected lot number is H01-16-117R.

The recalled product

Product
Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY
Manufacturer
Hobbs Medical, Inc.
Hazard
  • labeling-error
  • expired-device-use

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: M8494575OLY0 Lot Numbers: H01-16-117R

Distribution

Distributed nationwide across the United States.