FDA Recalls Posi-Stop Injection Needles Due to Manufacturing Debris
Hobbs Medical is recalling Posi-Stop Injection Needles (25 gauge) because some units contain debris in the needle shaft that blocks injection solution flow.
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: FDA Class II medical device recall involving blocked injection needles that prevent proper solution delivery. The hazard is a risk to proper medication administration; no illnesses or injuries are reported in the source, making this a theoretical risk-of-harm scenario.
Plain-English summary
Hobbs Medical, Inc. is recalling the Posi-Stop Injection Needle, 25 Gauge (Catalog Number 4723) distributed in the United States and Canada. Each package contains 10 needles.
Some units contained manufacturing debris lodged within the needle's inner sheath, blocking the inner diameter. This prevents injection solutions from flowing as intended through the needle tip, potentially preventing proper medication delivery.
The affected needles were distributed nationwide to Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin, West Virginia, and Canada. Affected lot numbers are H07-23-107 and H08-23-034 (Catalog Number 4723; UDI-DI: M84947230).
Healthcare facilities and providers who have these needles should discontinue use immediately and quarantine the affected units. Patients who have received injections using these needles should contact their healthcare provider if they have concerns about medication delivery.
The recalled product
- Product
- Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- needle-blockage
- injection-failure
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: 4723
- UDI-DI: M84947230
- Lot Numbers: H07-23-107
- H08-23-034.
Distribution
Distributed nationwide across the United States.
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