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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 201–220 of 615 recalls

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 IIICompleted

HAMILTON-H900 Humidifier, Models: 950001, 950004

Hamilton Medical AG

When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.

January 5, 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 →
Class IICompleted

Five IceRod" i-Thaw" Prostate Cryoablation Kit

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
Class IICompleted

IceEDGE" 2.4¿ 90p¿ Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →
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