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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 2341–2360 of 39,430 recalls

Class IOngoing

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180

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

LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

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-H1100

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 TYPE 1T150

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-Q190

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

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.

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 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.

September 11, 2025 · DeviceView details →
Class IOngoing

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

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-P190

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

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) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);

Boston Scientific Corporation

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

September 11, 2025 · DeviceView details →
Class IIOngoing

CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

Boston Scientific Corporation

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

September 11, 2025 · DeviceView details →
Class IOngoing

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60

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-1TH190

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

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) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);

Boston Scientific Corporation

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

September 11, 2025 · DeviceView details →
Class IOngoing

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180

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

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

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) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9) 72404438 (21CM IP IZ), (10) 72404439 (24CM IP IZ);

Boston Scientific Corporation

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

September 11, 2025 · DeviceView details →
Class IOngoing

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60

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-Q170

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

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter

Abbott

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

September 10, 2025 · DeviceView details →
Class IOngoing

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

Abbott

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

September 10, 2025 · DeviceView details →
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