| 2024-10-04 |
Class II
|
Ongoing |
Z-0476-2025 |
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723 |
— |
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0475-2025 |
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722 |
— |
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0474-2025 |
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718 |
— |
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0473-2025 |
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704 |
— |
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0472-2025 |
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721 |
— |
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0471-2025 |
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716 |
— |
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0470-2025 |
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706 |
— |
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0469-2025 |
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702 |
— |
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0468-2025 |
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720 |
— |
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing pro… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0070-2023 |
Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0069-2023 |
Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0068-2023 |
Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0067-2023 |
Hobbs Medical Polypectomy Snare Catalog Number: 7202 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0066-2023 |
Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0065-2023 |
Freeman Pancreatic Flexi-Stent Catalog Number: 6584 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0064-2023 |
Freeman Pancreatic Flexi-Stent Catalog Number: 6582 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0063-2023 |
Freeman Pancreatic Flexi-Stent Catalog Number: 6568 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0062-2023 |
Freeman Pancreatic Flexi-Stent Catalog Number: 6567 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0061-2023 |
Freeman Pancreatic Flexi-Stent Catalog Number: 6566 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0060-2023 |
Freeman Pancreatic Flexi-Stent Catalog Number: 6562 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0059-2023 |
Freeman Pancreatic Flexi-Stent Catalog Number: 6548 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0058-2023 |
Freeman Pancreatic Flexi-Stent Catalog Number: 6544 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0057-2023 |
Freeman Pancreatic Flexi-Stent Catalog Number: 6535 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0056-2023 |
Freeman Pancreatic Flexi-Stent Catalog Number: 6534 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0055-2023 |
Freeman Pancreatic Flexi-Stent Catalog Number: 6533 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0054-2023 |
Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0053-2023 |
Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0052-2023 |
Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0051-2023 |
Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0050-2023 |
Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0049-2023 |
Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0048-2023 |
Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0047-2023 |
Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0046-2023 |
Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0045-2023 |
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0044-2023 |
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0043-2023 |
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0042-2023 |
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0041-2023 |
Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0040-2023 |
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0039-2023 |
Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0038-2023 |
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0037-2023 |
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0036-2023 |
Hobbs Retrieval Forceps Catalog Number: 5018 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0035-2023 |
Hobbs Medical Grasping Forceps Catalog Number: 5008 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0034-2023 |
Hobbs Medical Grasping Forceps Catalog Number:5004 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0033-2023 |
Hobbs Helical Retrieval Basket Catalog Number: 4832 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0032-2023 |
Hobbs Helical Retrieval Basket Catalog Number: 4830 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0031-2023 |
Hobbs Helical Retrieval Basket Catalog Number: 4824 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0030-2023 |
Hobbs Helical Retrieval Basket Catalog Number: 4822 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0029-2023 |
Hobbs Helical Retrieval Basket Catalog Number: 4816 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0028-2023 |
Hobbs Helical Retrieval Basket Catalog Number: 4814 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0027-2023 |
Hobbs Helical Retrieval Basket Catalog Number: 4808 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0026-2023 |
Hobbs Helical Retrieval Basket Catalog Number: 4806 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0025-2023 |
Hobbs Posi-Stop Injection Needle Catalog Number: 4722 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0024-2023 |
Hobbs Posi-Stop Injection Needle Catalog Number: 4720 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0023-2023 |
Hobbs Posi-Stop Injection Needle Catalog Number: 4718 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0022-2023 |
Hobbs Posi-Stop Injection Needle Catalog Number: 4712 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0021-2023 |
Hobbs Posi-Stop Injection Needle Catalog Number: 4704 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0020-2023 |
Hobbs Posi-Stop Injection Needle Catalog Number: 4702 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0019-2023 |
Hobbs Scope Introducer Catalog Number: 4650 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0018-2023 |
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0017-2023 |
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0016-2023 |
Hobbs Medical Polypectomy Snare Catalog Number: 4564 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0015-2023 |
Hobbs Medical Polypectomy Snare Catalog Number: 4563 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0014-2023 |
Hobbs Medical Cytology Brush Catalog Number: 4206 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0013-2023 |
Hobbs Medical Cytology Brush Catalog Number: 4204 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0012-2023 |
Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0011-2023 |
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191 |
— |
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… |
| 2022-07-29 |
Class II
|
Ongoing |
Z-0010-2023 |
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190 |
— |
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… |
| 2022-06-03 |
Class II
|
Ongoing |
Z-1388-2022 |
Hobbs Medical Polypectomy Snare, Catalog No. 7202 |
— |
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 … |
| 2021-12-28 |
Class II
|
Ongoing |
Z-0711-2022 |
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as t… |
— |
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 … |