All Recalls

95,025 total recalls in our database

Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.

Boston Scientific

🏥 Medical Devices Class I - Dangerous

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

Jan 19, 2021 Infusion Pumps Nationwide View Details →

WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI

Nihon Kohden America

🏥 Medical Devices Class I - Dangerous

Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

Jan 8, 2021 Infusion Pumps Nationwide View Details →

HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

Bovie Medical

🏥 Medical Devices Class I - Dangerous

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

Feb 1, 2021 Surgical Instruments Nationwide View Details →

Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm)

CooperSurgical

🏥 Medical Devices Class I - Dangerous

The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet the released print dimensions.

Jan 21, 2021 Other Medical Devices Nationwide View Details →

ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.

Acist Medical Systems

🏥 Medical Devices Class I - Dangerous

Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.

Jan 22, 2021 Diagnostic Equipment Nationwide View Details →

Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY

Barco N.V.

🏥 Medical Devices Class I - Dangerous

A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.

Jan 22, 2021 Diagnostic Equipment View Details →

Hillsdale Furniture Jennings Counter and Bar Stools

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The stool seat can break off the base, posing a fall hazard.

Mar 10, 2021 Furniture Nationwide View Details →

Lifetime Products 6-foot Seminar Tables

Kingtec Group Vietnam Co. LTD, of Ben Cat Town, of Binh Duong Province, Vietnam

🏠 Consumer Products Class II - Moderate

The brace arms can fail to lock the table legs into place and the table can collapse, posing an injury risk to consumers.

Mar 10, 2021 Furniture Nationwide View Details →

Cabina Bunk Beds

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The screws that hold the bed's mattress foundation to the bed's guardrails can be loose and the mattress foundation can fall, posing a fall risk to children in the bunk bed.

Mar 4, 2021 Furniture Nationwide View Details →

Model Year 2020-2021 RANGER 1000, RANGER CREW 1000, RANGER XP 1000, and RANGER CREW XP 1000 and Model Year 2020 ProXD 2000G, ProXD 2000G H, ProXD 4000G, and ProXD 4000G H

Polaris Inc., of Medina, Minn.

🏠 Consumer Products Class II - Moderate

The throttle pedal can return to the idle position more slowly than anticipated once the pedal is released or stick in the depressed position, posing a crash hazard.

Mar 4, 2021 Home & Garden Nationwide View Details →