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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 3921–3940 of 39,430 recalls

Class IOngoing

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IIOngoing

Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

Potential breach in pouch packaging which could lead to loss of sterility.

February 13, 2025 · DeviceView details →
Class IIOngoing

Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

Potential breach in pouch packaging which could lead to loss of sterility.

February 13, 2025 · DeviceView details →
Class IOngoing

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

Smiths Medical ASD, Inc.

Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IIOngoing

Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

Potential breach in pouch packaging which could lead to loss of sterility.

February 13, 2025 · DeviceView details →
Class IIOngoing

Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

Potential breach in pouch packaging which could lead to loss of sterility.

February 13, 2025 · DeviceView details →
Class IIOngoing

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.

ZOLL Medical Corporation

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

February 13, 2025 · DeviceView details →
Class IIOngoing

Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRAPE,FEMORAL,RADIAL,5/CS; DRAPE,C-SECTION,FEN,CLR SCREEN,WIRE,7/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,U,ORTHOMAX,6/CS; DRAPE,SPLIT,77X120",10/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

Potential breach in pouch packaging which could lead to loss of sterility.

February 13, 2025 · DeviceView details →
Class IIOngoing

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.

ZOLL Medical Corporation

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IIOngoing

remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use

Remel, Inc

Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IIOngoing

Proxima Drape labeled as FACE LIFT. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

Potential breach in pouch packaging which could lead to loss of sterility.

February 13, 2025 · DeviceView details →
Class IIOngoing

namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT HEART,KIT-C*,MEM HLTHCARE, REF 60035977; 6) MTS,LEFT HEART,KIT,J*,M*,C*, REF 60040273; 7) MTS,LEFT HEART,KIT,C*,C*, REF 60100313; 8) MTS,3V,KIT-M*,MEMORIAL, REF 60131208; 9) MTS,3V,KIT-M*,MEMORIAL, REF 60131208; 10) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101; 11) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101; 12) MTS,LEFT HEART,MAN,KIT,S*-BALTIMORE, REF 60190947; 13) MTS-LEFT HEART,KIT-W*,H* HOSP PG, REF 60231052; 14) MTO,3-VALVE,KIT-T*,A*-PG, REF 65190182; 15) MTO,LEFT HEART,KIT,-,S* F*,-,PG, REF 65190474; 16) MTS,DR.,MCKAYS,4V,KIT,-,H* HOSP PG, REF 600800516; 17) MTS,EP,KIT,-,S*,TEACHING HOSPITAL PG, REF 601309013; 18) MTS,RHT,HRT-S* HOSP &,MC, REF 601905413; 19) MTS,PEDS,LFT,&,RT,HRT-S* HOSP, REF 601905414; 20) MTO,SCH,BEL,J*,H*-ST-PAUL,-,PG, REF 606604328; 21) LHK,-,MID,3VCOMP,OFF,PS,S10RA, REF 613000122; 22) MTS,LHK,W* HOSPITAL, REF 6010034281; 23) MTS,LHK,W* HOSPITAL, REF 6010034281; 24) MTS,LHK,P*,P* MED CTR, REF 6010171931; 25) MTS,LHK,M* HEALTHCARE,MGMT, REF 6061073001; 26) TVR US B* INTEGRATED SERVICE CENT, REF 601316711A; 27) LHK-S* MEDICAL CENTER,A*, REF 60190776A; 28) LHK,-,S*,AND,W* HOSPITAL, REF 60191118A.

MEDLINE INDUSTRIES, LP - Northfield

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

February 12, 2025 · DeviceView details →
Class IIOngoing

Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

Remel, Inc

Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.

February 12, 2025 · DeviceView details →
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