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.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
DeRoyal LAPINECTOMY PACK, REF 89-7198.10
DeRoyal Industries
Class I - Dangerous
XXX
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.
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 TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT MEDIUM OVERALL LENGTH 8-3/4" (225MM), REF F-5126
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 Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3007
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 ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010
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 euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5006
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 SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304
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.