Device recall enforcement reports
The weekly enforcement reports for device recalls, with the recall class. 40,481 records; openFDA updated it 2026-11-10. About this dataset
Newest records
- Class II35,732
- Class I3,677
- Class III1,040
- Not Yet Classified1
- B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
B Braun Medical Inc · Potential for leakage and backflow at the Safsite valve.
- Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155; Material Number: M001195250
Boston Scientific Cork, Ltd. · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcathe…
- PNE Lead Implant Kit REF: 1701
Axonics, Inc. · Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.
- Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130; Material Number: M001195740
Boston Scientific Cork, Ltd. · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcathe…
- MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P
Medline Industries, LP · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Philips North America · Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in l…
- VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Ventec Life Systems, Inc. · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilatio…
- Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
AVID Medical, Inc. · A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
- Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155; Material Number: M001195720
Boston Scientific Cork, Ltd. · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcathe…
- MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K
Medline Industries, LP · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.
Ventec Life Systems, Inc. · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilatio…
- Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105; Material Number: M001195400
Boston Scientific Cork, Ltd. · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcathe…
- Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
Medtronic Navigation, Inc. · Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and…
- VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.
Ventec Life Systems, Inc. · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilatio…
- Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155; Material Number: M001195620
Boston Scientific Cork, Ltd. · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcathe…
- Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610
Boston Scientific Cork, Ltd. · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcathe…
- Philips Lumify Diagnostic Ultrasound System
Philips Ultrasound, LLC · Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be un…
- Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670
Boston Scientific Cork, Ltd. · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcathe…
- Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130; Material Number: M001195660
Boston Scientific Cork, Ltd. · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcathe…
- VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
Ventec Life Systems, Inc. · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilatio…
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.