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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 721–740 of 1,000 recalls

Class IITerminated

SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

Discovery MR750w 3.0T nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

SIGNA Voyager nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

SIGNA Artist nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

Discovery MR750 3.0T nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

SIGNA Premier nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

Deerfield Imaging, Inc.

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

August 25, 2021 · DeviceView details →
Class IITerminated

Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

Atrium Medical Corporation

The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.

August 25, 2021 · DeviceView details →
Class IITerminated

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

Deerfield Imaging, Inc.

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

August 25, 2021 · DeviceView details →
Class IITerminated

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

Deerfield Imaging, Inc.

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

August 25, 2021 · DeviceView details →
Class IITerminated

HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm

Zhejiang Kindly Medical Devices Co., Ltd.

Potential for difficulty in safety mechanism activation.

August 24, 2021 · DeviceView details →
Class IITerminated

Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique

Bard Peripheral Vascular Inc

Due to misbranded products shipped to customers.

August 24, 2021 · DeviceView details →
Class IITerminated

McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS

Zhejiang Kindly Medical Devices Co., Ltd.

Potential for difficulty in safety mechanism activation.

August 24, 2021 · DeviceView details →
Class IITerminated

Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable.

Bard Peripheral Vascular Inc

Due to misbranded products shipped to customers.

August 24, 2021 · DeviceView details →
Class IITerminated

HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm

Zhejiang Kindly Medical Devices Co., Ltd.

Potential for difficulty in safety mechanism activation.

August 24, 2021 · DeviceView details →
Class IITerminated

McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS

Zhejiang Kindly Medical Devices Co., Ltd.

Potential for difficulty in safety mechanism activation.

August 24, 2021 · DeviceView details →
Class IITerminated

McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS

Zhejiang Kindly Medical Devices Co., Ltd.

Potential for difficulty in safety mechanism activation.

August 24, 2021 · DeviceView details →
Class IITerminated

McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS

Zhejiang Kindly Medical Devices Co., Ltd.

Potential for difficulty in safety mechanism activation.

August 24, 2021 · DeviceView details →
Class IITerminated

SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

Microbiologics Inc

The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).

August 20, 2021 · DeviceView details →
Class ITerminated

LiquaSonic Ultrasound Gel 250mL, Model No. 001205

Athena Medical Products Inc

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

August 20, 2021 · DeviceView details →
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