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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 3081–3100 of 39,430 recalls

Class IIOngoing

GS ENDOSCOPY PACK. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

CT DAVINCI. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class II
Ongoing

DA VINCI PACK URO/PROSTATE. Medical convenience kit.

AVID Medical, Inc.

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

June 11, 2025 · DeviceView details →
Class IIOngoing

MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

BostonSight SCLERAL Lens

Boston Foundation For Sight

Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

June 10, 2025 · DeviceView details →
Class IIOngoing

BostonSight PROSE Lens.

Boston Foundation For Sight

Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number 40KWFXPLUS.004, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.

Boston Scientific Corporation

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

SM_40HF_B_D_VIR3, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

SM_40HF_BDC3, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

SHIMADZU RF.004, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
Class IIOngoing

VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DEG/D0) VXSK0121 VXSK (180P RF WIRE 63CM/45DEG/D1) VXSK0122 VXSK (180P RF WIRE 63CM/55DEG/D0) VXSK0123 VXSK (180P RF WIRE 63CM/55DEG/D1) VXSK0124 VXSK (180P RF WIRE 63CM/90DEG/D0) VXSK0125 VXSK (230J RF WIRE 63CM/45DEG/D0) VXSK0111 VXSK (230J RF WIRE 63CM/45DEG/D1) VXSK0112 VXSK (230P RF WIRE 63CM/45DEG/D0) VXSK0131 VXSK (230P RF WIRE 63CM/45DEG/D1) VXSK0132 VXSK (230P RF WIRE 63CM/55DEG/D0) VXSK0133 VXSK (230P RF WIRE 63CM/55DEG/D1) VXSK0134 VXSK (230P RF WIRE 81CM/45DEG/D0) VXSK0137 VXSK-180P RF WIRE 63CM/45DEG/D0 SHEATH VXSK0021 VXSK-180P RF WIRE 63CM/45DEG/D1 SHEATH VXSK0022 VXSK-180P RF WIRE 63CM/55DEG/D1 SHEATH VXSK0024 VXSK-180P RF WIRE 63CM/90DEG/D0 SHEATH VXSK0025 VXSK-230P RF WIRE 63CM/45DEG/D0 SHEATH VXSK0031 VXSK-230P RF WIRE 63CM/45DEG/D1 SHEATH VXSK0032 VXSK-230P RF WIRE 63CM/55DEG/D1 SHEATH VXSK0034

Boston Scientific Corporation

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

June 10, 2025 · DeviceView details →
Class IIOngoing

VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.

Boston Scientific Corporation

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number 40KW-FX.899, Mobile X-ray system

SEDECAL SA

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

June 10, 2025 · DeviceView details →
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