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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 41–60 of 1,000 recalls

Class ITerminated

Anesthesia Circuit Kit Coax 1, MP02730

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

VentStar Basic (N) 180, MP00353

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

VentStar breathing bag Set (P) 110, MP00384

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

Anesthesia Circuit Kit Coax HEPA, MP17102

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

Ventstar Coax 230, MP03376

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

VentStar Bag Set (N) 110, MP00383

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

VentStar Watertrap (P) 180 w/oLL, MP00362

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

VentStar Coax (P) 150, MP00379

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class ITerminated

ID Coax 180, MP03375

Draeger Medical, Inc.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

April 17, 2023 · DeviceView details →
Class IITerminated

Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.

Mani, Inc. - Kiyohara Facility

A packaging defect may compromise the sterile barrier.

February 20, 2023 · DeviceView details →
Class IITerminated

Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities

Sensus Healthcare, Inc.

When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient.

February 10, 2023 · DeviceView details →
Class ITerminated

BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.

Avanos Medical, Inc.

Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.

February 3, 2023 · DeviceView details →
Class ITerminated

BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.

Avanos Medical, Inc.

Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.

February 3, 2023 · DeviceView details →
Class IITerminated

Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251

Avanos Medical, Inc.

Incorrect expiration date.

February 3, 2023 · DeviceView details →
Class IITerminated

Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.

Summit Medical, LLC

Sterile product pouches were not sealed.

January 13, 2023 · DeviceView details →
Class IITerminated

Mammotome MammoStar Biopsy Site Identified, REF STAR1401

Carbon Medical Technologies, Inc.

The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle.

December 16, 2022 · DeviceView details →
Class IITerminated

DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10

DeRoyal Industries Inc

DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.

December 12, 2022 · DeviceView details →
Class ITerminated

SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.

Cardiac Assist, Inc

A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.

December 5, 2022 · DeviceView details →
Class IITerminated

Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)

Remington Medical, Inc.

The stylet is longer than specified on the label

December 2, 2022 · DeviceView details →
Class IITerminated

ActiveAid 922, Shower/Commode Chair

Altimate Medical, Inc.

Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position.

November 30, 2022 · DeviceView details →
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