Hobbs Posi-Stop Injection Needle recalled for incorrect expiration dates
Hobbs Medical is recalling Hobbs Posi-Stop Injection Needles due to incorrect expiration dates on device labels that extend the shelf life. Affected devices have lot numbers ending in 'R' distributed from 2018–2020.
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 2/5 (Moderate).
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 recall involving incorrect expiration date labeling on a medical device. The source does not report any illnesses or injuries. The hazard is a labeling error that could result in use of expired devices, fitting the rubric criterion for 'minor labeling errors' with no reported harm.
Plain-English summary
Hobbs Medical, Inc. is recalling the Hobbs Posi-Stop Injection Needle (Catalog Number 4704) because the device label displays an incorrect expiration date that extends the product's shelf life.
The affected devices are identified by lot numbers ending in 'R' (UDI-DI: M84947040, Lot Number H01-17-198R) with expiration dates between November 1, 2022 and September 1, 2025. In the United States, these devices were distributed from March 25, 2018 to September 28, 2020. Worldwide distribution also included Canada, Austria, Belgium, Finland, and Norway.
The recalled product
- Product
- Hobbs Posi-Stop Injection Needle Catalog Number: 4704
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 7
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: M84947040 Lot Numbers: H01-17-198R
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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