Medical DeviceMar 26, 2025
B Braun Medical Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged recall — FDA Z-1397-2025
Increased risk for valve housing detachment causing leakage.
Class IIFDA: OngoingB Braun Medical Inc.
21,924medical device recall records
2,160FDA Class I records
8firms with 5+ records
MEDLINE INDUSTRIES, LP…730 records
Database records
Records — page 153
21,924 detailed records are currently available in this category.
Medical DeviceMar 26, 2025
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 recall — FDA Z-1388-2025
the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in…
Class IIFDA: OngoingBeckman Coulter, Inc.
Medical DeviceMar 26, 2025
Oridion Medical 1987 Microstream Instructions for Use and Part Number used with - Product recall — FDA Z-1376-2025
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect…
Class IIFDA: OngoingOridion Medical 1987 Ltd.
Medical DeviceMar 26, 2025
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm recall — FDA Z-1280-2025
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Class IFDA: OngoingSmiths Medical ASD, Inc.
Medical DeviceMar 26, 2025
Merge Healthcare VERICIS, Merge Cardio recall — FDA Z-1400-2025
When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical…
Class IIFDA: OngoingMerge Healthcare, Inc.
Medical DeviceMar 19, 2025
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO recall — FDA Z-1328-2025
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
Class IIFDA: OngoingStryker Corporation
Medical DeviceMar 19, 2025
Medtronic Perfusion Systems Aortic Root Cannula: 1 recall — FDA Z-1306-2025
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not…
Class IFDA: OngoingMedtronic Perfusion Systems
Medical DeviceMar 19, 2025
ZOLL Powerheart G5 AED recall — FDA Z-1321-2025
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class IIFDA: OngoingZOLL Medical Corporation
Medical DeviceMar 19, 2025
CardioFocus CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial recall — FDA Z-1307-2025
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Class IIFDA: OngoingCardioFocus, Inc.
Medical DeviceMar 19, 2025
Aesculap Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil recall — FDA Z-1312-2025
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Class IIFDA: OngoingAesculap Inc.
Medical DeviceMar 19, 2025
ZOLL Powerheart G5 AED recall — FDA Z-1319-2025
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class IIFDA: OngoingZOLL Medical Corporation
Medical DeviceMar 19, 2025
CareFusion 303 BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software recall — FDA Z-1304-2025
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Class IFDA: OngoingCareFusion 303, Inc.
Medical DeviceMar 19, 2025
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 recall — FDA Z-1326-2025
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash…
Class IIFDA: OngoingBeckman Coulter, Inc.
Medical DeviceMar 19, 2025
ZOLL Powerheart G5 AED recall — FDA Z-1320-2025
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class IIFDA: OngoingZOLL Medical Corporation
Medical DeviceMar 19, 2025
Cordis US Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F recall — FDA Z-1330-2025
Catheter manufactured at the incorrect length.
Class IIFDA: OngoingCordis US Corp
Medical DeviceMar 19, 2025
ZOLL Powerheart G5 AED recall — FDA Z-1322-2025
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class IIFDA: OngoingZOLL Medical Corporation
Medical DeviceMar 19, 2025
ZOLL Powerheart G5 AED recall — FDA Z-1316-2025
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class IIFDA: OngoingZOLL Medical Corporation
Medical DeviceMar 19, 2025
ZOLL Powerheart G5 AED recall — FDA Z-1317-2025
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class IIFDA: OngoingZOLL Medical Corporation
Medical DeviceMar 19, 2025
TruScan Body compatible with CONELOG 3.8 recall — FDA Z-1313-2025
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
Class IIFDA: OngoingTruAbutment Inc.
Medical DeviceMar 19, 2025
Aesculap Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf recall — FDA Z-1308-2025
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Class IIFDA: OngoingAesculap Inc.
Medical DeviceMar 19, 2025
GE Medical Systems GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed recall — FDA Z-1297-2025
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceMar 19, 2025
Smiths Medical ASD Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 recall — FDA Z-1289-2025
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…
Class IFDA: OngoingSmiths Medical ASD, Inc.
Medical DeviceMar 19, 2025
Aesculap Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery recall — FDA Z-1309-2025
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Class IIFDA: OngoingAesculap Inc.
Medical DeviceMar 19, 2025
GE Medical Systems GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed recall — FDA Z-1301-2025
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in…
Class IIFDA: OngoingGE Medical Systems, LLC
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.