| 2026-03-03 |
Class II
|
Ongoing |
Z-1812-2026 |
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO |
— |
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. |
| 2025-12-18 |
Class II
|
Ongoing |
Z-1362-2026 |
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA… |
— |
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current d… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1298-2026 |
Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 |
— |
Nasal feeding tube packaged without the nasal transfer tube component. |
| 2024-10-31 |
Class II
|
Ongoing |
Z-0582-2025 |
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile. |
— |
Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation kno… |
| 2024-08-29 |
Class II
|
Ongoing |
Z-0036-2025 |
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemosta… |
— |
Specific lots of product have been manufactured with nonconforming raw materials. |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0463-2024 |
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree |
— |
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscop… |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0462-2024 |
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree |
— |
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscop… |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0461-2024 |
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree |
— |
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscop… |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0460-2024 |
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree |
— |
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscop… |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0459-2024 |
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree |
— |
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscop… |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0458-2024 |
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree |
— |
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscop… |
| 2023-11-03 |
Class II
|
Ongoing |
Z-0457-2024 |
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree |
— |
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscop… |
| 2023-06-22 |
Class II
|
Ongoing |
Z-2253-2023 |
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended… |
— |
Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or with… |
| 2023-06-22 |
Class II
|
Ongoing |
Z-2252-2023 |
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intende… |
— |
Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or with… |
| 2023-05-22 |
Class II
|
Ongoing |
Z-1979-2023 |
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346 |
— |
There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and conse… |
| 2023-05-22 |
Class II
|
Ongoing |
Z-1978-2023 |
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663; |
— |
There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and conse… |
| 2020-02-04 |
Class II
|
Terminated |
Z-1746-2020 |
HEMO-10 Hemospray Endoscopic Hemostat |
— |
Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the ca… |
| 2020-02-04 |
Class II
|
Terminated |
Z-1745-2020 |
HEMO-7 Hemospray Endoscopic Hemostat |
— |
Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the ca… |