Medical DeviceApr 23, 2025
Ballard Closed Suction Catheters recall — FDA Z-1527-2025
Lack of sterility assurance for closed suction catheter systems
Class IFDA: OngoingAvanos Medical, Inc.
April 2025 recalls — page 4
These records include useful source details for the selected month.
Medical DeviceApr 23, 2025
Maquet VH-3010 Power Supply recall — FDA Z-1577-2025
Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
Class IIFDA: OngoingMaquet Cardiovascular, LLC
Medical DeviceApr 23, 2025
Medline Convenience kits used for various procedures: 1) PERI GYN PACK recall — FDA Z-1615-2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 23, 2025
Stryker GmbH Guide Wire with Ruler Tube 3x1000 mm DIA recall — FDA Z-1621-2025
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Class IIFDA: OngoingStryker GmbH
Medical DeviceApr 23, 2025
ID NOW RSV 24T recall — FDA Z-1573-2025
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Class IIFDA: OngoingAbbott Diagnostics Scarborough, Inc.
Medical DeviceApr 23, 2025
Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX recall — FDA Z-1594-2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 23, 2025
Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE recall — FDA Z-1609-2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 23, 2025
Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK recall — FDA Z-1608-2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 23, 2025
Stryker GmbH Guide Wire with Ruler Tube 3x800 mm DIA recall — FDA Z-1620-2025
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Class IIFDA: OngoingStryker GmbH
Medical DeviceApr 23, 2025
Rover Mobile X-ray System recall — FDA Z-1578-2025
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Class IIFDA: OngoingMicro-X Ltd.
Medical DeviceApr 23, 2025
Rover Mobile X-ray System recall — FDA Z-1579-2025
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Class IIFDA: OngoingMicro-X Ltd.
Medical DeviceApr 23, 2025
Medline Convenience kits used for various procedures: 1) IV PACK SOUTH recall — FDA Z-1604-2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 23, 2025
Bard Access Systems BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540 recall — FDA Z-1507-2025
Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material…
Class IFDA: OngoingBard Access Systems, Inc.
Medical DeviceApr 23, 2025
Ballard Closed Suction Catheters recall — FDA Z-1525-2025
Lack of sterility assurance for closed suction catheter systems
Class IFDA: OngoingAvanos Medical, Inc.
Medical DeviceApr 23, 2025
Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK recall — FDA Z-1607-2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 23, 2025
Medline Convenience kits used for various procedures: 1) T A PACK recall — FDA Z-1597-2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 23, 2025
Thoratec HeartMate Mobile Power Unit: REF: 107754, NA recall — FDA Z-1570-2025
Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system…
Class IFDA: OngoingThoratec LLC
Medical DeviceApr 23, 2025
Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK recall — FDA Z-1600-2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 23, 2025
Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK recall — FDA Z-1593-2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 23, 2025
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK recall — FDA Z-1590-2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 23, 2025
Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF recall — FDA Z-1619-2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 23, 2025
Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF recall — FDA Z-1589-2025
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 23, 2025
Philips DXR System, DuraDiagnost Rel. 4 recall — FDA Z-1554-2025
Potential for collimator to fall as a result of incorrect installation.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 23, 2025
AutoPulse NXT Platform recall — FDA Z-1533-2025
AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
Class IFDA: OngoingZOLL Circulation, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.