Hobbs Scope Introducer Recalled for Incorrect Label Expiration Date
Hobbs Medical is recalling 140 units of its Hobbs Scope Introducer due to incorrect label expiration dates that extend the shelf life. Affected devices were distributed in the US and internationally from March 2018 to September 2020.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device recall involving a labeling error that compromises device safety. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score per the rubric.
Plain-English summary
Hobbs Medical, Inc. is recalling 140 units of the Hobbs Scope Introducer (Catalog Number 4650) because the device label displays an incorrect expiration date. This mislabeling extends the stated shelf life beyond the actual safe period for the product.
Medical devices used past their actual expiration date may not function as intended or may pose safety risks to patients. The affected devices have label expiration dates ranging from November 1, 2022 to September 1, 2025.
The recalled devices were distributed worldwide to the United States and internationally to Canada, Austria, Belgium, Finland, and Norway. Distribution occurred between March 25, 2018 and September 28, 2020. The affected lot numbers are H04-18-182R and H04-18-181R, or any kits containing at least one device with a lot number ending in R.
Users and healthcare facilities should discontinue use of scope introducers from the affected lot numbers and contact Hobbs Medical or their supplier for further guidance. Patients who may have received care involving these devices should consult with their healthcare provider.
The recalled product
- Product
- Hobbs Scope Introducer Catalog Number: 4650
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 140
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: M84946500 Lot Numbers: H04-18-182R H04-18-181R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 61 recalled by Hobbs Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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