Posi-Stop Injection Needles Recalled Due to Manufacturing Debris Blocking Injection Flow
Hobbs Medical recalls Posi-Stop injection needles because manufacturing debris can block the needle, preventing injection solutions from flowing properly. Affected units were distributed across multiple US states and Canada.
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 for a functional defect with no reported injuries or hospitalizations. The manufacturing debris presents a risk of medication administration failure, placing this in the High severity category per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles, 25 Gauge (Catalog Number 4718) because some units contain manufacturing debris inside the needle that blocks injection flow. This prevents injection solutions from flowing as intended through the needle tip.
The affected needles were distributed to multiple US states including Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin, West Virginia, and to Canada. The affected lot numbers are H08-23-264 and H09-23-112.
The recalled product
- Product
- Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 12
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 (4)
- Catalog Number: 4718
- UDI-DI: M84947180
- Lot Numbers: H08-23-264
- H09-23-112.
Distribution
Part of a larger recall action
This product is one of 9 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.
See all 9 products in this recall →Related recalls
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