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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 2421–2440 of 39,430 recalls

Class IIOngoing

GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube

Wipro GE Healthcare Private Ltd.

Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips S4-1 Ultrasound Transducer

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

September 5, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component

Exactech, Inc.

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips X3-1 Ultrasound Transducer

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips OMNI II TEE Ultrasound Transducer

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

September 5, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

Spacelabs Healthcare, Inc.

Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips L17-5 Ultrasound Transducer

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

September 5, 2025 · DeviceView details →
Class IIOngoing

GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube

Wipro GE Healthcare Private Ltd.

Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.

September 5, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

Spacelabs Healthcare, Inc.

Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips Mini Multi TEE Ultrasound Transducer

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips OMNI III TEE Ultrasound Transducer

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

September 5, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

Spacelabs Healthcare, Inc.

Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.

September 5, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component

Exactech, Inc.

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips 3D6-2 Ultrasound Transducer

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips X7-2 Ultrasound Transducer

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips C9-4 Ultrasound Transducer

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

September 5, 2025 · DeviceView details →
Class IIIOngoing

Philips L12-5 Ultrasound Transducer

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

September 5, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component

Exactech, Inc.

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

September 5, 2025 · DeviceView details →
Class IIOngoing

Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE, FREDX5522-PMA, FREDX3522-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5532-PMA, FREDX4013-PMA, FREDX3513-PMA, FREDX4515-PMA, FREDX3517-PMA, MV-F352427X

MICROVENTION INC.

Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.

September 5, 2025 · DeviceView details →
Class IIOngoing

Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224

American Contract Systems Inc.

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

September 4, 2025 · DeviceView details →
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