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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 181–200 of 392 recalls

Class IICompleted

Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.

Biosense Webster, Inc.

There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism

February 26, 2021 · DeviceView details →
Class IICompleted

Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010

Aesculap Implant Systems LLC

Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.

February 19, 2021 · DeviceView details →
Class IICompleted

Enteral Infusion Pump

Cardinal Health 200, LLC

The potential for air appearing in the enteral feed pumping set tubing during set-up.

January 19, 2021 · DeviceView details →
Class IICompleted

Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope

Shent USA, Inc.

Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226, (Grasper/Retriever, Alligator Jaw, Rat Tooth, 2.4 mm x 8 mm x 230 cm) may actually be catalog #7208, Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm).

January 12, 2021 · DeviceView details →
Class IICompleted

Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope

Shent USA, Inc.

Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226, (Grasper/Retriever, Alligator Jaw, Rat Tooth, 2.4 mm x 8 mm x 230 cm) may actually be catalog #7208, Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm).

January 12, 2021 · DeviceView details →
Class IICompleted

Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L

Covidien Llc

May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis

November 23, 2020 · DeviceView details →
Class IICompleted

Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S

Covidien Llc

May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis

November 23, 2020 · DeviceView details →
Class IICompleted

IceSeed" 1.5 Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

IcePearl" 2.1 CX 90¿ Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

IceRod" 1.5 CX 90¿ Cryoablation Needle¿

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

Five IceSphere" Prostate Cryoablation Kit

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

IcePearl" 2.1 CX Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

IceRod" 1.5 i-Thaw" Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

IceSeed" 1.5 90¿ Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

IceSeed" 1.5 MRI Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

IceSphere" 1.5 CX 90¿ Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

IceSphere" 1.5 Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

IceSphere" 1.5 S 90¿ Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

IceFORCE" 2.1 CX 90¿ Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

IceRod" 1.5 PLUS 90¿ Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
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