TELEFLEX LLC
128 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for TELEFLEX LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-07-05FDA-DeviceClass ISlick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- 2023-07-05FDA-DeviceClass ISlick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170070
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- 2023-07-05FDA-DeviceClass ISlick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- 2023-07-05FDA-DeviceClass ISlick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- 2023-07-05FDA-DeviceClass ISlick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- 2023-07-05FDA-DeviceClass ISlick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- 2023-06-07FDA-DeviceClass IITeleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the cartridge, the clip is mounted in a more variable position, allowing the clips to load farther back in the clip applier jaw grooves. This may potentially result in inappropriate or inadequate clip application to vascular structures.
- 2023-05-24FDA-DeviceClass IITeleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.
The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.
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