The Recall Desk
ModerateFDA (Devices)·Z-0011-2023·Announced 2022-10-19

Hobbs Medical Spray Catheter Recalled for Incorrect Expiration Date on Label

Hobbs Medical Spray Catheter devices sold between March 2018 and September 2020 have incorrect expiration dates on their labels. The error may extend the device's shelf life beyond its actual expiration.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II medical device recall involving a labeling error where the expiration date is incorrect. No illnesses or injuries have been reported, and the hazard is theoretical. Per the severity rubric, this classification falls under 'Minor labeling errors,' resulting in a Moderate (2) severity rating.

Plain-English summary

Hobbs Medical, Inc. is recalling certain Spray Catheter devices (The Mistifier model, 2.6mm, 165cm) used in endoscopy procedures. The product labels display an incorrect expiration date that extends the shelf life beyond the actual device expiration, potentially allowing the device to be used past its true expiration date.

The recall affects Spray Catheter devices with lot numbers ending in "R" or kits containing at least one device with such a lot number. Devices were distributed nationwide in the United States and internationally to Canada, Austria, Belgium, Finland, and Norway from March 25, 2018 to September 28, 2020. The affected product is identified by UDI-DI M84921910.

Clinics and healthcare facilities should verify whether their devices are affected by checking the lot numbers and dates. Devices in the recalled lot range should not be used. Consult with Hobbs Medical, Inc. for instructions on returning or disposing of affected units. As of the recall announcement, no illnesses or injuries associated with this issue have been reported.

The recalled product

Product
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Endoscopy Catheter
Hazard
  • incorrect-expiration-date

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: M84921910 Lot Numbers: H03-16-015R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category