Stafford Springs, CT, United States
Hobbs Medical, Inc. recalls
5 recalls recorded since 2018, most recently on 4 October 2024. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)4
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 4 October 2024
- Reason
- Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
- Distribution
- Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0476-2025, Z-0475-2025, Z-0472-2025, Z-0474-2025, Z-0471-2025, Z-0473-2025, Z-0469-2025, Z-0468-2025, Z-0470-2025
- Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
- Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
- Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
- Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
- Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
- Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
- Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702
- Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
- and 1 more product lines
Ongoing Class II Medical devices
- Recall started
- 29 July 2022
- Reason
- Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0070-2023, Z-0051-2023, Z-0049-2023, Z-0018-2023, Z-0025-2023, Z-0034-2023, Z-0069-2023, Z-0054-2023, Z-0041-2023, Z-0013-2023, Z-0055-2023, Z-0030-2023 and 49 more
- Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY
- Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507
- Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
- Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
- Hobbs Posi-Stop Injection Needle Catalog Number: 4722
- Hobbs Medical Grasping Forceps Catalog Number:5004
- Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY
- Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529
- and 53 more product lines
Ongoing Class II Medical devices
- Recall started
- 3 June 2022
- Reason
- During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.
- Distribution
- Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1388-2022
- Hobbs Medical Polypectomy Snare, Catalog No. 7202
Ongoing Class II Medical devices
- Recall started
- 28 December 2021
- Reason
- The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0711-2022
- Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compressi
Terminated Class II Medical devices
- Recall started
- 1 May 2018
- Terminated
- 10 April 2020
- Reason
- Device was marketed for uses outside the 510(k) clearance.
- Distribution
- US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2052-2018
- Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.