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/BERN/1RO/130; Material Number: M001195240
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/021/BERN/2RO/130; Material Number: M001195340
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/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810
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/021/SWAN/1RO/130; Material Number: M001195300
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: (list truncated)
Medline Industries, LP · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number: M001195230
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/155; Material Number: M001195450
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/TRANSEND/027/STRAIGHT/1RO/130; Material Number: M001195910
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/TRANSEND/027/BERN/1RO/130; Material Number: M001195940
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/021/BERN/2RO/155; Material Number: M001195350
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/STRAIGHT/1RO/155; Material Number: M001195420
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/021/STRAIGHT/1RO/105; Material Number: M001195200
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…
- CareLink Clinic, REF: MMT-7350
Medtronic MiniMed, Inc. · CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values e…
- VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. 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/STRAIGHT/1RO/155; Material Number: M001195220
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: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOTIC PK-LF, Medline Kit Nu…
Medline Industries, LP · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130; Material Number: M001195410
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…
- Think Surgical Square Driver REF: 109126
Think Surgical, Inc. · Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilli…
- Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500
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/021/SWAN/1RO/155; Material Number: M001195310
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…
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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.