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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 321–340 of 1,000 recalls

Class IOngoing

IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

IMPRIS Imaging Inc

There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

September 30, 2025 · DeviceView details →
Class IOngoing

IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida

IMPRIS Imaging Inc

There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

September 30, 2025 · DeviceView details →
Class IOngoing

Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A

B BRAUN MEDICAL INC

The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.

September 30, 2025 · DeviceView details →
Class IOngoing

IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA

IMPRIS Imaging Inc

There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

September 30, 2025 · DeviceView details →
Class IOngoing

IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra

IMPRIS Imaging Inc

There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

September 30, 2025 · DeviceView details →
Class IOngoing

CODMAN Disposable Perforator 11mm. Cranial Perforator.

Integra LifeSciences Corp. (NeuroSciences)

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

September 26, 2025 · DeviceView details →
Class IOngoing

CODMAN Disposable Perforator 9mm. Cranial Perforator.

Integra LifeSciences Corp. (NeuroSciences)

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

September 26, 2025 · DeviceView details →
Class IOngoing

Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophilic coating to facilitate lubricity from tip to 40 cm proximal. The proximal end of the Mega Ballast incorporates a Luer fitting hub for the attachment of accessories. The Mega Ballast is provided sterile, non-pyrogenic, and is intended for single use only. Component: Not a component

BALT USA, LLC

Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.

September 25, 2025 · DeviceView details →
Class IOngoing

Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-125-W ZTA2-P-44-179 ZTA2-P-44-179-W ZTA2-P-44-233 ZTA2-P-44-233-W ZTA2-P-46-125 ZTA2-P-46-125-W ZTA2-P-46-179 ZTA2-P-46-179-W ZTA2-P-46-233-W ZTA2-PT-40-36-167 ZTA2-PT-40-36-167-W ZTA2-PT-40-36-217 ZTA2-PT-40-36-217-W ZTA2-PT-42-38-173 ZTA2-PT-42-38-173-W ZTA2-PT-42-38-225 ZTA2-PT-42-38-225-W ZTA2-PT-44-40-179 ZTA2-PT-44-40-179-W ZTA2-PT-44-40-233-W ZTA2-PT-46-42-179 ZTA2-PT-46-42-179-W ZTA2-PT-46-42-233 ZTA2-PT-46-42-233-W ZTA2-P-46-233 ZTA2-PT-44-40-233 ZTA2-P-40-217 ZTA2-P-40-117 ZTA2-P-40-167-DEMO ZTA2-P-44-152-W ZTA2-P-40-142 ZTA2-P-44-152 ZTA2-P-40-142-W

Cook Medical Incorporated

Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.

September 18, 2025 · DeviceView details →
Class IOngoing

Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

Percussionaire Corporation

IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.

September 17, 2025 · DeviceView details →
Class IOngoing

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Controller, Packaged, JP, Product Code: 0042-0000-JP. 8. Impella Controller, Packaged, UK, Product Code: 0042-0000-UK. 9. Impella Controller, Packaged, US, Product Code: 0042-0000-US. 10. Impella Optical Controller, Packaged, AU, Product Code: 0042-0010-AU. 11. Impella Optical Controller, Packaged, EU, Product Code: 0042-0010-EU. 12. Impella Optical Controller, Packaged, IN, Product Code: 0042-0010-IN. 13. Impella Optical Controller, Packaged, UK, Product Code: 0042-0010-UK. 14. Impella Optical Controller, Packaged, US, Product Code: 0042-0010-US. 15. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP. 16. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP-L. 17. Optical AIC w/Impella Connect, Pack'd, CA, Product Code: 0042-0040-CA. 18. Optical AIC w/Impella Connect, Pack'd, EU, Product Code: 0042-0040-EU. 19. Optical, AIC, Impella Connect, Pkgd, AU, Product Code: 0042-0040-AU. 20. Optical, AIC, Impella Connect, Pkgd, UK, Product Code: 0042-0040-UK. 21. Optical, AIC, Impella Connect, Pkgd, US, Product Code: 0042-0040-US.

Abiomed, Inc.

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

September 16, 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 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 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 →
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