Hobbs Medical, Inc.
FDA Regulatory Profile
Hobbs Medical, Inc. appears in FDA public data with 73 recalls, 21 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0472-2025, Class II) was initiated on October 4, 2024. Its most recent 510(k) clearance was granted on September 24, 2024.
Summary
- Total Recalls
- 73
- 510(k) Clearances
- 21
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0472-2025 | Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721 | October 4, 2024 |
| Z-0471-2025 | Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716 | October 4, 2024 |
| Z-0473-2025 | Class II | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704 | October 4, 2024 |
| Z-0476-2025 | Class II | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723 | October 4, 2024 |
| Z-0474-2025 | Class II | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718 | October 4, 2024 |
| Z-0475-2025 | Class II | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722 | October 4, 2024 |
| Z-0470-2025 | Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706 | October 4, 2024 |
| Z-0468-2025 | Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720 | October 4, 2024 |
| Z-0469-2025 | Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702 | October 4, 2024 |
| Z-0017-2023 | Class II | Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620 | July 29, 2022 |
| Z-0069-2023 | Class II | Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY | July 29, 2022 |
| Z-0025-2023 | Class II | Hobbs Posi-Stop Injection Needle Catalog Number: 4722 | July 29, 2022 |
| Z-0034-2023 | Class II | Hobbs Medical Grasping Forceps Catalog Number:5004 | July 29, 2022 |
| Z-0068-2023 | Class II | Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY | July 29, 2022 |
| Z-0015-2023 | Class II | Hobbs Medical Polypectomy Snare Catalog Number: 4563 | July 29, 2022 |
| Z-0039-2023 | Class II | Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023 | July 29, 2022 |
| Z-0028-2023 | Class II | Hobbs Helical Retrieval Basket Catalog Number: 4814 | July 29, 2022 |
| Z-0042-2023 | Class II | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028 | July 29, 2022 |
| Z-0049-2023 | Class II | Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501 | July 29, 2022 |
| Z-0013-2023 | Class II | Hobbs Medical Cytology Brush Catalog Number: 4204 | July 29, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241874 | Aspiration Catheter (2189) | September 24, 2024 |
| K182927 | Pulmonary Cytology Brush | February 7, 2020 |
| K093079 | TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U | August 2, 2010 |
| K030765 | HOBBS MISTIFIER SPRAY CATHETER | June 9, 2003 |
| K933354 | HOBBS MEDICAL CLEANING BRUSH | October 28, 1993 |
| K922396 | FUJINON FORCEPS -- MODIFICATION | December 10, 1992 |
| K921026 | PRESSURE GAUGE | April 24, 1992 |
| K914358 | ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP | November 19, 1991 |
| K893729 | HOBBS MEDICAL MICROBIOLOGY BRUSH | August 28, 1989 |
| K872509 | LINDEN STONE EXTRACTION BALLOON | September 22, 1987 |
| K860593 | ET/RT PAPILLOTOME | July 22, 1986 |
| K860582 | TBI NEEDLE | March 4, 1986 |
| K844550 | HOBBS MEDICAL/JAYCO ASPIRATION CATHETER | January 3, 1985 |
| K844074 | HOBBS MEDICAL POLYPECTOMY SNARE | January 3, 1985 |
| K834413 | DILATION BALLOON CATHETER | May 22, 1984 |
| K834351 | BILIARY INDWELLING STENT | March 22, 1984 |
| K834401 | URETERAL DOUBLE PIGTAIL STENT | March 22, 1984 |
| K834414 | ERCP CANNULA | February 4, 1984 |
| K834402 | GASTROINTESTINAL SHEATH BRUSH | February 4, 1984 |
| K833124 | HOBBS MEDICAL RETRIEVAL BASKET | November 29, 1983 |