DeRoyal BASIC NEURO PACK, REF 89-7258.13
DeRoyal Industries
Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
DeRoyal EYE PACK, REF 89-4051.09
DeRoyal Industries
Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
DeRoyal CATARACT PACK, REF 89-10086.05
DeRoyal Industries
Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
ARROW INTERNATIONAL
Class I - Dangerous
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
DeRoyal LAPINECTOMY PACK, REF 89-7198.10
DeRoyal Industries
Class I - Dangerous
XXX
Class I - Dangerous
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.
GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
DeRoyal Industries
Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental
Stradis Medical, LLC
Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
DeRoyal NEURO PACK, REF 89-10171.06
DeRoyal Industries
Class I - Dangerous
XXX
HENRY SCHEIN, BREAST PACK, Item No.570-2397
Stradis Medical, LLC
Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
DeRoyal CRANI PACK, REF 89-10242.04
DeRoyal Industries
Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131
Stradis Medical, LLC
Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
DEWEI MEDICAL EQUIPMENT CO
Class I - Dangerous
Products were distributed in the United States without FDA authorization or clearance.
Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL LENGTH 8-1/2" (215MM) , REF F-1035
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Philips North America
Class I - Dangerous
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5127
Carefusion 2200
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.
Medical Action Industries, Inc. 306
Class I - Dangerous
The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.
Class I - Dangerous
BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.