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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 841–860 of 1,000 recalls

Class IITerminated

Bone Marrow Transplantation biopsy needle

M.D.L. S.r.l.

Sterility assurance may be compromised.

August 5, 2021 · DeviceView details →

Class IITerminated

Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341

Beckman Coulter Inc.

Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute

August 5, 2021 · DeviceView details →

Class IITerminated

cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

Roche Molecular Systems, Inc.

Customers have reported an increased number of false positive SARS-CoV-2 results.

August 4, 2021 · DeviceView details →

Class IITerminated

Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes

Abbott Molecular, Inc.

Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.

August 4, 2021 · DeviceView details →

Class IITerminated

smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

Smiths Medical ASD Inc.

The incorrect device is contained in the package.

August 4, 2021 · DeviceView details →

Class IITerminated

Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy

Olympus Corporation of the Americas

Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.

August 3, 2021 · DeviceView details →

Class IITerminated

AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)

Fresenius Medical Care Holdings, Inc.

AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation

August 3, 2021 · DeviceView details →

Class IITerminated

Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.

Magnolia Medical Technologies, Inc.

Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).

August 2, 2021 · DeviceView details →

Class IITerminated

BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375

Leica Microsystems, Inc.

Product may not perform as specified in IFU.

July 30, 2021 · DeviceView details →

Class IITerminated

Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781358

Philips North America Llc

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

July 30, 2021 · DeviceView details →

Class IITerminated

Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781341

Philips North America Llc

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

July 30, 2021 · DeviceView details →

Class IITerminated

Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630

Paragon 28, Inc.

A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.

July 30, 2021 · DeviceView details →

Class IITerminated

Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781277 (OUS)

Philips North America Llc

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

July 30, 2021 · DeviceView details →

Class IITerminated

Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781315

Philips North America Llc

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

July 30, 2021 · DeviceView details →

Class IITerminated

Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781342

Philips North America Llc

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

July 30, 2021 · DeviceView details →

Class IITerminated

Arjo Disposable Repositioning Sling, Model AHD001

Getinge Dominican Republic SA

Sling loop straps on device pose a trip hazard.

July 30, 2021 · DeviceView details →

Class IITerminated

Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 78127 (OUS)

Philips North America Llc

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

July 30, 2021 · DeviceView details →

Class IITerminated

Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781357 (OUS)

Philips North America Llc

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

July 30, 2021 · DeviceView details →

Class IIITerminated

Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.

Sentinel CH SpA

Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.

July 29, 2021 · DeviceView details →

Class IITerminated

OASIS MRI System

Hitachi Healthcare Americas Corporation

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

July 29, 2021 · DeviceView details →

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