Teleflex
FDA adverse event reports naming Teleflex as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: TELEFLEX.
- Total reports
- 1,888
- Deaths
- 11
- Injuries
- 71
- Malfunctions
- 1,795
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Tube, Tracheal (W/Wo Connector)BTR273
- Humidifier, Respiratory Gas, (Direct Patient Interface)BTT213
- Laryngoscope, RigidCCW196
- Clip, ImplantableFZP112
- Nebulizer (Direct Patient Interface)CAF91
- Circulator, Breathing-CircuitCAG81
- Stapler, SurgicalGAG63
- Laparoscope, General & Plastic SurgeryGCJ40
- Heater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerBZE39
- Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ39
Recent recalls
- 2026-07-01Open, ClassifiedDevice Design
Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
- 2023-07-05Open, ClassifiedOther
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
- 2023-07-05Open, ClassifiedOther
Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
- 2023-07-05Open, ClassifiedOther
Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
- 2023-06-29Open, ClassifiedUnder Investigation by firm
Slick 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.
- 2023-06-29Open, ClassifiedUnder Investigation by firm
Slick 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.
- 2023-06-29Open, ClassifiedUnder Investigation by firm
Slick 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.
- 2023-06-29Open, ClassifiedUnder Investigation by firm
Slick 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.
- 2023-06-29Open, ClassifiedUnder Investigation by firm
Slick 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.
- 2023-06-29Open, ClassifiedUnder Investigation by firm
Slick 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.
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