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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 921–940 of 1,000 recalls

Class IOngoing

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190

Olympus Corporation of the Americas

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

October 12, 2023 · DeviceView details →
Class IOngoing

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160

Olympus Corporation of the Americas

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

October 12, 2023 · DeviceView details →
Class IOngoing

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180

Olympus Corporation of the Americas

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

October 12, 2023 · DeviceView details →
Class IOngoing

EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170

Olympus Corporation of the Americas

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

October 12, 2023 · DeviceView details →
Class IOngoing

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC

Olympus Corporation of the Americas

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

October 12, 2023 · DeviceView details →
Class IOngoing

VariSoft infusion set, Model Number 1002828

Unomedical A/S

The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.hyperglycemia). Diabetic ketoacidosis.

October 11, 2023 · DeviceView details →
Class IOngoing

VariSoft infusion set, Model Number 1002827

Unomedical A/S

The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.

October 11, 2023 · DeviceView details →
Class IOngoing

VariSoft infusion set, Model Number 1002830

Unomedical A/S

The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.

October 11, 2023 · DeviceView details →
Class IOngoing

CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

Maquet Medical Systems USA

Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.

October 10, 2023 · DeviceView details →
Class IOngoing

CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.

Integra LifeSciences Corp.

Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.

October 5, 2023 · DeviceView details →
Class IOngoing

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

Covidien

Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation.

September 28, 2023 · DeviceView details →
Class IOngoing

StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.

Medtronic Navigation, Inc.

Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.

September 27, 2023 · DeviceView details →
Class IOngoing

Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

Cordis US Corp

Non-sterile product labeled as sterile was distributed.

September 26, 2023 · DeviceView details →
Class IOngoing

Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

Olympus Corporation of the Americas

There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.

September 22, 2023 · DeviceView details →
Class IOngoing

8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

B. Braun Medical, Inc.

Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.

September 21, 2023 · DeviceView details →
Class IOngoing

8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

B. Braun Medical, Inc.

Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.

September 21, 2023 · DeviceView details →
Class IOngoing

Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

Demonstrated recognition and compatibility issues with syringe infusion pumps.

September 20, 2023 · DeviceView details →
Class IOngoing

Monoject 20 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

Demonstrated recognition and compatibility issues with syringe infusion pumps.

September 20, 2023 · DeviceView details →
Class IOngoing

Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

Demonstrated recognition and compatibility issues with syringe infusion pumps.

September 20, 2023 · DeviceView details →
Class IOngoing

Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

Demonstrated recognition and compatibility issues with syringe infusion pumps.

September 20, 2023 · DeviceView details →
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