Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 2,251–2,300 of 7,959

Medical Device Recall · September 12, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac 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.
Class II
Medical Device Recall · September 12, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac 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.
Class II
Medical Device Recall · September 12, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac 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.
Class II
Medical Device Recall · September 12, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac 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.
Class II
Medical Device Recall · September 12, 2025
UIH Technologies LLC
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Class II
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
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.
Class I
Medical Device Recall · September 11, 2025
Boston Scientific Corporation
CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6)
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Class II
Medical Device Recall · September 11, 2025
Boston Scientific Corporation
TENACIO Pump without InhibiZone; UPN: 72404420;
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Class II
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
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.
Class I
Medical Device Recall · September 11, 2025
Boston Scientific Corporation
CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Class II
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
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.
Class I
Medical Device Recall · September 11, 2025
Boston Scientific Corporation
TENACIO Pump with InhibiZone; UPN: 72404429;
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Class II
Medical Device Recall · September 11, 2025
Insulet Corporation
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneous
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.
Class II
Medical Device Recall · September 11, 2025
Boston Scientific Corporation
LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6)
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Class II
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
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.
Class I
Medical Device Recall · September 11, 2025
Boston Scientific Corporation
CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6)
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Class II
Medical Device Recall · September 11, 2025
Boston Scientific Corporation
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Class II
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
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.
Class I
Medical Device Recall · September 11, 2025
Ferno-Washington Inc
FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
The fastening post hardware could loosen allowing the fastening post to detach from the cot
Class II
Medical Device Recall · September 11, 2025
Medline Industries, LP
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Class II
Medical Device Recall · September 11, 2025
CareFusion 303, Inc.
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 S
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
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.
Class I
Medical Device Recall · September 11, 2025
Ethicon Endo-Surgery Inc
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
The devices were shipped unsterilized.
Class II
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
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.
Class I
Medical Device Recall · September 11, 2025
Theken Companies LLC
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
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
Class II
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
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.
Class I
Medical Device Recall · September 11, 2025
Olympus Corporation of the Americas
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
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.
Class I
Medical Device Recall · September 10, 2025
Medline Industries, LP
Medline Adult Anesthesia Set, REF DYNJ39985G
Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
Class II
Medical Device Recall · September 10, 2025
Abbott
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I
Medical Device Recall · September 10, 2025
Abbott
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I
Medical Device Recall · September 10, 2025
Abbott
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I
Medical Device Recall · September 10, 2025
Abbott
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I
Medical Device Recall · September 10, 2025
Abbott
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I
Medical Device Recall · September 9, 2025
BioPro, Inc.
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Class II
Medical Device Recall · September 9, 2025
NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
Class I
Medical Device Recall · September 9, 2025
MedicalCommunications GmbH
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System
Potential that the measured value may be smaller than the actual area.
Class II