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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 161–180 of 1,000 recalls

Class ITerminated

NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.

Synapse Biomedical Inc

Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events include pain, muscle fatigue and decreased breathing effectiveness, arrhythmia or cardiac arrest, or the device may stop unexpectedly.

July 11, 2022 · DeviceView details →
Class ITerminated

INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.

Intera Oncology, Inc.

Higher than expected flow rate.

July 10, 2022 · DeviceView details →
Class IITerminated

Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708

Trinity Sterile, Inc.

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

June 29, 2022 · DeviceView details →
Class IITerminated

Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

Trinity Sterile, Inc.

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

June 29, 2022 · DeviceView details →
Class IITerminated

Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF

Trinity Sterile, Inc.

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

June 29, 2022 · DeviceView details →
Class IITerminated

SX-One MicroKnife

SONEX HEALTH LLC

Potential of dull blade

June 29, 2022 · DeviceView details →
Class IITerminated

Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF

Trinity Sterile, Inc.

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

June 29, 2022 · DeviceView details →
Class IIITerminated

BIOPHEN UFH Control Plasma

Aniara Diagnostica LLC

Incorrect product labeling was included in the package.

June 28, 2022 · DeviceView details →
Class IITerminated

(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.

Smith & Nephew, Inc.

The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

June 27, 2022 · DeviceView details →
Class IITerminated

LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control

LumiraDx

Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.

June 24, 2022 · DeviceView details →
Class IITerminated

LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip

LumiraDx

Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.

June 24, 2022 · DeviceView details →
Class IIITerminated

ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000

Zeiss, Carl Inc

An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.

June 24, 2022 · DeviceView details →
Class ITerminated

ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3392 (Abacus V3.3 SE), and 8300-3393 (Abacus V3.3 ME). Commonly used with ExactaMix automated compounding devices (ExactaMix 1200 and ExactaMix 2400).

Baxter Healthcare Corporation

There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.

June 22, 2022 · DeviceView details →
Class IITerminated

Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0

Randox Laboratories Ltd.

Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.

June 22, 2022 · DeviceView details →
Class IITerminated

nordicBrainEX, software versions 2.21 through 2.3.10

NordicNeuroLab AS

When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.

June 16, 2022 · DeviceView details →
Class IITerminated

SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.

Stryker Instruments Div. of Stryker Corporation

When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.

June 15, 2022 · DeviceView details →
Class IITerminated

Centricity PACS Software Version 7.0 SP0.0.4.7

GE Healthcare, LLC

The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.

June 14, 2022 · DeviceView details →
Class IITerminated

RayStation 11B

RAYSEARCH LABORATORIES AB

This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.

June 10, 2022 · DeviceView details →
Class IIITerminated

Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

Randox Laboratories Ltd.

A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.

June 9, 2022 · DeviceView details →
Class IIITerminated

Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

Randox Laboratories Ltd.

A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.

June 9, 2022 · DeviceView details →
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