Thoracentesis Tray

Reports per year

Source: FDA adverse event reports by year received, 2019–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-07-02Open, ClassifiedNonconforming Material/Component

  OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal spaces during an acute drainage / aspiration procedure.

  Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

• 2026-07-02Open, ClassifiedNonconforming Material/Component

  CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sarnpling.

  Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

• 2026-07-02Open, ClassifiedNonconforming Material/Component

  5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein.

  Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

• 2025-12-05Open, ClassifiedProcess control

  Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,

  Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.

• Open, ClassifiedUnder Investigation by firm

  REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,

  There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.

• TerminatedUnder Investigation by firm

  Thora-Para 5 Fr Non-Valved Catheter Drainage Tray

  The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

• TerminatedUnder Investigation by firm

  Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray

  The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

• TerminatedUnder Investigation by firm

  Safe-T-Centesis 6 Fr Catheter Drainage Tray

  The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

• TerminatedUnder Investigation by firm

  Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine

  The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

• TerminatedUnder Investigation by firm

  Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray

  The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.