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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 21–40 of 1,000 recalls

Class IITerminated

SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568

Avanos Medical, Inc.

Some of the ambIT kits were potentially distributed without an air in-line filter.

April 24, 2023 · DeviceView details →
Class IITerminated

AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

Avanos Medical, Inc.

Some of the ambIT kits were potentially distributed without an air in-line filter.

April 24, 2023 · DeviceView details →
Class II
Terminated

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 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 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 →
Class IITerminated

DeRoyal Tonsillectomy Tray, REF 89-10698.01

DeRoyal Industries Inc

DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.

November 28, 2022 · DeviceView details →
Class IITerminated

MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1

Mobius Imaging, LLC

Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing.

November 18, 2022 · DeviceView details →
Class IITerminated

Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187

ConMed Corporation

Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.

November 18, 2022 · DeviceView details →
Class IITerminated

Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit

Medical Action Industries, Inc. 306

XXX

November 4, 2022 · DeviceView details →
Class IITerminated

VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

Icotec Ag

During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.

November 3, 2022 · DeviceView details →
Class IITerminated

IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834

Randox Laboratories Ltd.

Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results

November 1, 2022 · DeviceView details →
Class IITerminated

IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832

Randox Laboratories Ltd.

Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results

November 1, 2022 · DeviceView details →
Class IITerminated

Unity Total Knee System. Used for knee prosthesis in total knee replacement

Corin Ltd

The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

October 31, 2022 · DeviceView details →
Class IITerminated

Baxter Electrocardiograph, ELI 380 -DCS21

Baxter Healthcare Corporation

One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.

October 31, 2022 · DeviceView details →
Class IITerminated

EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base

MicroPort Orthopedics Inc.

One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.

October 28, 2022 · DeviceView details →
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