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
- Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290
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/SINGLE/027/BERN/1RO/130; Material Number: M001195440
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/027/BERN/1RO/155; Material Number: M001195750
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…
- Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
Life Technologies Holdings Pte Ltd · DNA or RNA sequencing system software has vulnerabilities.
- Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280
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…
- VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. 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…
- Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, 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…
- MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SK…
Medline Industries, LP · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. 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…
- Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260
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: 8801075, Sterile EO, 5/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…
- MEDLINE medical convenience kits labeled as (list truncated)
Medline Industries, LP · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. 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…
- Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood C…
Greiner Bio-One North America, Inc. · Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) a…
- Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Softwa…
Medtronic MiniMed, Inc. · A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienc…
- Techno-Path Multichem AE Unassayed Level 2 REF: AE622X
TECHNO-PATH MANUFACTURING LTD. · A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. A…
- ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846…
Beckman Coulter, Inc. · Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifuga…
- Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840
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…
- InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
Medtronic Neuromodulation · Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may r…
- Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/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…
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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.