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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 2041–2060 of 39,430 recalls

Class IIOngoing

Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.

Mindray DS USA, Inc. dba Mindray North America

Potential for anesthesia leakage.

October 20, 2025 · DeviceView details →
Class IIOngoing

MONARCH Bronchoscope. Model Number: MBR-000211-B

Auris Health, Inc

Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

October 18, 2025 · Device
View details →
Class IIOngoing

Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.

TECHNO-PATH MANUFACTURING LTD.

Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.

October 17, 2025 · DeviceView details →
Class IIOngoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;

Mozarc Medical US LLC

A potential issue with the seal integrity of header bag packaging.

October 17, 2025 · DeviceView details →
Class IOngoing

BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide

CareFusion 303, Inc.

If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.

October 17, 2025 · DeviceView details →
Class IIOngoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;

Mozarc Medical US LLC

A potential issue with the seal integrity of header bag packaging.

October 17, 2025 · DeviceView details →
Class IIOngoing

Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

Straumann USA LLC

The possibility for this product that is intended for demonstration purposes only to be placed in patients.

October 17, 2025 · DeviceView details →
Class IIOngoing

Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length

Olympus Corporation of the Americas

Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.

October 17, 2025 · DeviceView details →
Class IIOngoing

Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.

TECHNO-PATH MANUFACTURING LTD.

Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.

October 17, 2025 · DeviceView details →
Class IIOngoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;

Mozarc Medical US LLC

A potential issue with the seal integrity of header bag packaging.

October 17, 2025 · DeviceView details →
Class IIOngoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;

Mozarc Medical US LLC

A potential issue with the seal integrity of header bag packaging.

October 17, 2025 · DeviceView details →
Class IIOngoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;

Mozarc Medical US LLC

A potential issue with the seal integrity of header bag packaging.

October 17, 2025 · DeviceView details →
Class IIOngoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;

Mozarc Medical US LLC

A potential issue with the seal integrity of header bag packaging.

October 17, 2025 · DeviceView details →
Class IIOngoing

IntelePACS - InteleConnect / TechPortal

INTELERAD MEDICAL SYSTEMS INCORPORATED

Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.

October 17, 2025 · DeviceView details →
Class IIOngoing

VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

Canon Medical System, USA, INC.

Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.

October 16, 2025 · DeviceView details →
Class IIOngoing

Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.

October 16, 2025 · DeviceView details →
Class IIOngoing

BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;

Becton Dickinson & Company

BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.

October 14, 2025 · DeviceView details →
Class IIOngoing

Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

Olympus Corporation of the Americas

Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.

October 14, 2025 · DeviceView details →
Class IIOngoing

BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

Beckman Coulter Ireland, Inc.

Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.

October 14, 2025 · DeviceView details →
Class IIOngoing

Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

Paragon 28, Inc.

Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.

October 13, 2025 · DeviceView details →
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