Posi-Stop Injection Needles Recalled for Manufacturing Debris Blocking Flow
Hobbs Medical is recalling Posi-Stop Injection Needles because manufacturing debris blocks the needle, preventing injection solutions from flowing properly. The 70 affected units were distributed to healthcare facilities in multiple U.S. states and Canada.
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: This FDA Class II medical device recall involves a functional defect (manufacturing debris blocking proper needle function) with no reported illnesses or injuries. It qualifies as a risk-of-harm product where injury has not yet been reported, consistent with High severity criteria.
Plain-English summary
Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles, 23 Gauge (Catalog Number 4720) due to a manufacturing defect. This is a Class II recall by the U.S. Food and Drug Administration.
The affected lot numbers are H07-23-103, H07-23-104, H08-23-020, and H09-23-111. Investigations found that some units contained manufacturing debris within the inner sheath of the needle. This debris blocks the needle's inner diameter, preventing injection solutions from flowing through the needle tip as intended.
The recalled needles were distributed to healthcare facilities across multiple U.S. states (Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin, and West Virginia) and Canada. In total, 70 units were affected.
Healthcare providers should not use these needles. Affected units should be discontinued from use and returned to the manufacturer or disposed of in accordance with local medical waste disposal regulations.
The recalled product
- Product
- Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 70
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 (6)
- Catalog Number: 4720
- UDI-DI: M84947200
- Lot Numbers: H07-23-103
- H07-23-104
- H08-23-020
- H09-23-111.
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
Same manufacturer · Hobbs Medical, Inc.
See all →- HighPosi-Stop Injection Needle Recalled Due to Manufacturing Debris Blockage
FDA (Devices) · 2024-11-27
- HighPosi-Stop Injection Needle Recall Due to Manufacturing Debris
FDA (Devices) · 2024-11-27
- HighPosi-Stop Injection Needles Recalled Due to Manufacturing Debris Blocking Injection Flow
FDA (Devices) · 2024-11-27
- HighPosi-Stop Injection Needles recalled for manufacturing debris blockage
FDA (Devices) · 2024-11-27
- HighInjection Needles Recalled for Manufacturing Debris Blocking Medication Flow
FDA (Devices) · 2024-11-27
Same hazard · injection failure
See all →- HighFDA Recalls Posi-Stop Injection Needles Due to Manufacturing Debris
FDA (Devices) · 2024-11-27
- ModerateSiemens CT Scanner Recall Due to Contrast Injection Failure
FDA (Devices) · 2016-08-31
- HighNovo Nordisk Recalls Norditropin Pens Due to Delivery System Defect
FDA (Drugs) · 2016-06-15
Similar recalls
- HighHobbs Posi-Stop Injection Needle recalled for incorrect expiration date labeling
FDA (Devices) · 2022-10-19
- HighHobbs Posi-Stop Injection Needles Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2022-10-19
- ModerateHobbs Posi-Stop Injection Needle recalled for incorrect expiration dates
FDA (Devices) · 2022-10-19
- HighHobbs Posi-Stop Injection Needle recalled for incorrect expiration date on label
FDA (Devices) · 2022-10-19
- HighHobbs Posi-Stop Injection Needle Recall - Incorrect Expiration Date
FDA (Devices) · 2022-10-19
- HighStimuplex A Injection Needles Recalled for DEHP Mislabeling
FDA (Devices) · 2024-06-19