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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 821–840 of 1,000 recalls

Class IIOngoing

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

Inspire Medical Systems Inc.

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

May 11, 2026 · DeviceView details →

Class IIOngoing

5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 3. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 4. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.

Fresenius Medical Care Holdings, Inc.

Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

May 11, 2026 · DeviceView details →

Class IIOngoing

Power Over Fiber Base Module

Terex Utilities

Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56. Missing certification and proper manufacturer's ID label. Was not accompanied by compliant User Information. Formalized quality control procedures and record keeping of QC testing was not performed to IEC 60825-1 nor 21 CFR 1040.10 standards. Sales information did not convey required class designation and warning statement

May 11, 2026 · DeviceView details →

Class IIOngoing

VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

Ventec Life Systems, Inc.

Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.

May 8, 2026 · DeviceView details →

Class IIOngoing

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system

Instrumentation Laboratory

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

May 8, 2026 · DeviceView details →

Class IIOngoing

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system

Instrumentation Laboratory

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

May 8, 2026 · DeviceView details →

Class IIOngoing

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system

Instrumentation Laboratory

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

May 8, 2026 · DeviceView details →

Class IIOngoing

Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 REF: MSWSTDA3580 UDI-DI codes: 00884450529645 00884450529690 00884450529744 REF: MSWSTDS35150 UDI-DI codes: 00884450529690 00884450529744 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 REF: MSWSTFA3580 UDI-DI code: 00884450529515 REF: MSWSTFS35150 UDI-DI code: 00884450529553 The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

Merit Medical Systems, Inc.

Due to unsealed portions of pouches.

May 8, 2026 · DeviceView details →

Class IIOngoing

GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

GE Medical Systems SCS

GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.

May 8, 2026 · DeviceView details →

Class IIOngoing

Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer

Instrumentation Laboratory

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

May 8, 2026 · DeviceView details →

Class IIOngoing

TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components

Think Surgical, Inc.

Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.

May 8, 2026 · DeviceView details →

Class IIOngoing

Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C

AMD Medicom Inc.

Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

May 8, 2026 · DeviceView details →

Class IIOngoing

Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C

AMD Medicom Inc.

Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

May 8, 2026 · DeviceView details →

Class IIOngoing

GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part No. 00024015859

Instrumentation Laboratory

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

May 8, 2026 · DeviceView details →

Class IIOngoing

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system

Instrumentation Laboratory

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

May 8, 2026 · DeviceView details →

Class IIOngoing

Bicarby Dialysate; Model number: RFP-400-G;

Fresenius Medical Care Holdings, Inc.

There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.

May 7, 2026 · DeviceView details →

Class IIOngoing

Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A

TELEFLEX LLC

Due to out-of-specification, or potential out-of-specification, levels of endotoxins

May 7, 2026 · DeviceView details →

Class IIOngoing

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay

Siemens Healthcare Diagnostics, Inc.

A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.

May 7, 2026 · DeviceView details →

Class IIOngoing

Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.

AVID Medical, Inc.

Incorrect concentration of Betadine solution contained within certain AVID convenience kits.

May 7, 2026 · DeviceView details →

Class IIOngoing

3mensio Workstation (Vascular Fenestrated) software

PIE Medical Imaging B.V.

User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information

May 7, 2026 · DeviceView details →

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