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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 221–240 of 1,000 recalls

Class IIIOngoing

Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512

Agilent Technologies, Inc.

Label provided for substrate vail contained incorrect expiration date.

May 20, 2022 · DeviceView details →

Class IIIOngoing

Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

Volcano Corp

Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

May 13, 2022 · DeviceView details →

Class IIIOngoing

Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797

Volcano Corp

Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

May 13, 2022 · DeviceView details →

Class IIITerminated

KWIK-STIK" plus: Clostridium perfringens

Microbiologics Inc

Labeling error.

May 6, 2022 · DeviceView details →

Class IIITerminated

putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY

Cerapedics, Inc.

Patient chart label contains incorrect Part Number and volume amount.

April 14, 2022 · DeviceView details →

Class IIITerminated

CK MB Calibrator, Catalogue Number CK2393

Randox Laboratories Ltd.

Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.

March 25, 2022 · DeviceView details →

Class IIITerminated

Regard Custom Procedure Kits containing BD Luer Lok Access Devices

ROi CPS LLC

Recalled devices were packaged in convenience kits.

February 24, 2022 · DeviceView details →

Class IIIOngoing

Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

Beckman Coulter, Inc.

IRISpec CA failures for glucose.

February 16, 2022 · DeviceView details →

Class IIITerminated

Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008

Cytocell Ltd.

Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is 2022-02 and not 2023-05 as shown on the outer label.

February 14, 2022 · DeviceView details →

Class IIITerminated

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918

Cook Medical Incorporated

IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

February 14, 2022 · DeviceView details →

Class IIITerminated

Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;

Cook Medical Incorporated

IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

February 14, 2022 · DeviceView details →

Class IIITerminated

TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A

Cytocell Ltd.

May show unexpected locus specific signals in addition to those at 14q32.

February 4, 2022 · DeviceView details →

Class IIIOngoing

MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems

Volcano Corp

Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets.

February 3, 2022 · DeviceView details →

Class IIIOngoing

IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

Volcano Corp

Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.

January 24, 2022 · DeviceView details →

Class IIITerminated

HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak

Physio-Control, Inc.

Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.

January 13, 2022 · DeviceView details →

Class IIIOngoing

BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200

Becton Dickinson & Company

May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts

January 6, 2022 · DeviceView details →

Class IIITerminated

Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.

LivaNova Deutschland GmbH

One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.

December 17, 2021 · DeviceView details →

Class IIITerminated

20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box

CellEra LLC

Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.

December 15, 2021 · DeviceView details →

Class IIITerminated

20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box

CellEra LLC

Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.

December 15, 2021 · DeviceView details →

Class IIITerminated

20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box

CellEra LLC

Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.

December 15, 2021 · DeviceView details →

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