Browse Device Recalls
22 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 22 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 22 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 18, 2025 | Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784... | Due to product that may contain a void in the material that separates the wire guide and cutting ... | Class II | Wilson-Cook Medical Inc. |
| Dec 15, 2025 | Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 | Nasal feeding tube packaged without the nasal transfer tube component. | Class II | Wilson-Cook Medical Inc. |
| Oct 31, 2024 | Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, ste... | Specific lots of product have been manufactured with nonconforming raw materials resulting in the... | Class II | Wilson-Cook Medical Inc. |
| Aug 29, 2024 | Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Steril... | Specific lots of product have been manufactured with nonconforming raw materials. | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; use... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; us... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used ... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; use... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used ... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Nov 3, 2023 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used ... | Nonconforming devices while manufactured correctly, do not comply to their design requirements. ... | Class II | Wilson-Cook Medical Inc. |
| Jun 22, 2023 | Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion... | Non-conforming product may appear in the field as inability to advance or retract the basket, or ... | Class II | Wilson-Cook Medical Inc. |
| Jun 22, 2023 | Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion ... | Non-conforming product may appear in the field as inability to advance or retract the basket, or ... | Class II | Wilson-Cook Medical Inc. |
| May 22, 2023 | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G5657... | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, wh... | Class II | Wilson-Cook Medical Inc. |
| May 22, 2023 | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G210... | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, wh... | Class II | Wilson-Cook Medical Inc. |
| Feb 4, 2020 | HEMO-10 Hemospray Endoscopic Hemostat | Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when... | Class II | Wilson-Cook Medical Inc. |
| Feb 4, 2020 | HEMO-7 Hemospray Endoscopic Hemostat | Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when... | Class II | Wilson-Cook Medical Inc. |
| Jul 24, 2019 | Hemospray Endoscopic Hemostat | Potential for Hemospray device to be unable to spray powder due to misassembly of devices. | Class II | Wilson-Cook Medical Inc. |
| Jun 14, 2019 | Acuject Variable Injection Needle | Potential for occluded injection needles. | Class II | Wilson-Cook Medical Inc. |
| Jan 4, 2019 | Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical... | Complaints of the snare loop not completely retracting and/or misshaping of the snare loop. | Class II | Wilson-Cook Medical Inc. |
| Dec 18, 2018 | COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4S... | The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) ... | Class II | Wilson-Cook Medical Inc. |
| Dec 18, 2018 | COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with ... | The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) ... | Class II | Wilson-Cook Medical Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.