Posi-Stop Injection Needle Recalled Due to Manufacturing Debris Blockage
Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Lot H11-23-057) because some units contain manufacturing debris that blocks the needle opening, preventing injection solutions from flowing properly.
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 a Class II medical device recall with no reported illnesses or injuries. The hazard—manufacturing debris blocking needle flow—represents a risk of harm to patients, as injection solutions may not flow as intended. This falls under the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' scoring 3 (High).
Plain-English summary
Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles, 23 Gauge (Catalog Number 4721, Lot Number H11-23-057). The recall affects 15 units distributed nationwide in the United States (Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin, and West Virginia) and in Canada.
Some units of the recalled needles contain debris from the manufacturing process that collects inside the inner sheath of the needle. This debris blocks the needle opening (inner diameter), preventing injection solutions from flowing as intended.
Healthcare facilities and clinics that received these needles should stop using them and quarantine any remaining stock. Patients or healthcare providers who have received injections using these needles should contact their healthcare provider with any concerns. Hobbs Medical is working with the FDA on this Class II recall.
The recalled product
- Product
- Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- manufacturing-debris
- 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 (3)
- Catalog Number: 4721
- UDI-DI: M84947210
- Lot Number: H11-23-057.
Distribution
Distributed nationwide across the United States.
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