The Recall Desk
HighFDA (Devices)·Z-0012-2023·Announced 2022-10-19

Hobbs Medical Flex-Ez Guide Wire With Incorrect Expiration Date

Hobbs Medical Flex-Ez Guide Wire devices were labeled with an incorrect expiration date that extends shelf life beyond the intended duration. Affected devices were distributed in the US and internationally 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 is an FDA Class II recall of a medical device (inherent risk-of-harm product) with a labeling error extending shelf life. No illnesses or injuries have been reported, but the risk of using degraded equipment warrants a High severity rating.

Plain-English summary

Hobbs Medical, Inc. is recalling Flex-Ez Guide Wire (Ref: 3412), a disposable medical device used in endoscopy procedures. The affected devices were labeled with an incorrect expiration date that extends shelf life beyond the intended duration.

Devices with lot numbers ending in R, or kits containing at least one such device, are subject to this recall. The recalled devices were distributed in the United States, Canada, Austria, Belgium, Finland, and Norway between March 25, 2018 and September 28, 2020. Affected devices carry expiration dates ranging from November 1, 2022 to September 1, 2025.

The incorrect labeling may result in devices being used beyond their intended shelf life, potentially compromising device integrity and performance.

The recalled product

Product
Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Endoscopy Equipment
Hazard
  • expiration-dating-error
  • shelf-life-extension

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)

  • UD-DI: M84934120 Lot Numbers: H05-18-091R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category