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.

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DateProductReasonClassFirm
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.