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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 2321–2340 of 39,430 recalls

Class IIOngoing

Cardiac Workstation 7000; Model Number: 860441;

Philips North America

Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

September 12, 2025 · DeviceView details →
Class IIOngoing

Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

September 12, 2025 · Device
View details →
Class IIOngoing

Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes

Medline Industries, LP

Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.

September 11, 2025 · DeviceView details →
Class IOngoing

EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

Olympus Corporation of the Americas

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

September 11, 2025 · DeviceView details →
Class IOngoing

BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites 10012645, Back Check Valve, Non-vented, SmartSite Y-site 2426-0500, Back Check Valve, 3 SmartSite Y-sites 2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite Y-sites 11522558, Ball Valve, Back Check Valve, 3 SmartSite Y-sites 2410-0500, 2 SmartSite Y-Sites 2232-0007, 0.2 Micron Filter 11613191, 0.2 Micron Filter, Ball Valve, SmartSite" Port (Burette), 2 SmartSite Y-sites 10012144, 3 SmartSite Y-Sites, Check Valve 10013034, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 4-way Stopcock 10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site 11582773, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 3-way Stopcock

CareFusion 303, Inc.

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

September 11, 2025 · DeviceView details →
Class IOngoing

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

Olympus Corporation of the Americas

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

September 11, 2025 · DeviceView details →
Class IOngoing

BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2

Olympus Corporation of the Americas

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

September 11, 2025 · DeviceView details →
Class IOngoing

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60

Olympus Corporation of the Americas

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

September 11, 2025 · DeviceView details →
Class IIOngoing

FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.

Ferno-Washington Inc

The fastening post hardware could loosen allowing the fastening post to detach from the cot

September 11, 2025 · DeviceView details →
Class IIOngoing

TENACIO Pump without InhibiZone; UPN: 72404420;

Boston Scientific Corporation

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

September 11, 2025 · DeviceView details →
Class IOngoing

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150

Olympus Corporation of the Americas

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

September 11, 2025 · DeviceView details →
Class IIOngoing

ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80

Ethicon Endo-Surgery Inc

The devices were shipped unsterilized.

September 11, 2025 · DeviceView details →
Class IOngoing

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180

Olympus Corporation of the Americas

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

September 11, 2025 · DeviceView details →
Class IOngoing

BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100

Olympus Corporation of the Americas

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

September 11, 2025 · DeviceView details →
Class IOngoing

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC

Olympus Corporation of the Americas

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

September 11, 2025 · DeviceView details →
Class IOngoing

BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170

Olympus Corporation of the Americas

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

September 11, 2025 · DeviceView details →
Class IIOngoing

iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm

Theken Companies LLC

Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

September 11, 2025 · DeviceView details →
Class IOngoing

BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2

Olympus Corporation of the Americas

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

September 11, 2025 · DeviceView details →
Class IOngoing

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

Olympus Corporation of the Americas

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

September 11, 2025 · DeviceView details →
Class IIOngoing

TENACIO Pump with InhibiZone; UPN: 72404429;

Boston Scientific Corporation

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

September 11, 2025 · DeviceView details →
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