Portex 4698P-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20351688032802), received between Jul 18, 2025 and Aug 26, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

31 other recalls cover devices cleared under the same FDA submission (K952516); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "DRAW AND THE ITEM EXPLODED, AND BLOOD WAS GETTING ON NURSES. PATIENT AND MULTIPLE NURSES WERE AFFECTED". THE EVENT OCCURRED DURING PATIENT USE. ADVERSE CLINICAL EFFECTS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897224 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE VENTED CAP WAS LEAKING, NOT SEALING WHEN IN CONTACT WITH BLOOD WHICH WAS CONFIRMED THAT THE USERS ARE TWISTING CAPS AS THEY PUSH DOWN FIRMLY TO CLOSE, PER GUIDANCE PROVIDED. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541423 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE VENTED CAP WAS LEAKING, NOT SEALING WHEN IN CONTACT WITH BLOOD WHICH WAS CONFIRMED THAT THE USERS ARE TWISTING CAPS AS THEY PUSH DOWN FIRMLY TO CLOSE, PER GUIDANCE PROVIDED. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541394 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE VENTED CAP WAS LEAKING, NOT SEALING WHEN IN CONTACT WITH BLOOD WHICH WAS CONFIRMED THAT THE USERS ARE TWISTING CAPS AS THEY PUSH DOWN FIRMLY TO CLOSE, PER GUIDANCE PROVIDED. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541335 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE VENTED CAP WAS LEAKING, NOT SEALING WHEN IN CONTACT WITH BLOOD WHICH WAS CONFIRMED THAT THE USERS ARE TWISTING CAPS AS THEY PUSH DOWN FIRMLY TO CLOSE, PER GUIDANCE PROVIDED. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541312 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K952516. One submission often covers many models, so check the product and lot details in each record.

• Z-1100-2026 · Dec 19, 2025 · Open, Classified
  Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
• Z-0141-2024 · Sep 6, 2023 · Open, Classified
  Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
• Z-1715-2020 · Jan 7, 2020 · Terminated
  Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
• Z-1716-2020 · Jan 7, 2020 · Terminated
  Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
• Z-0843-2019 · Jun 22, 2018 · Terminated
  Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 405
• Z-0842-2019 · Jun 22, 2018 · Terminated
  Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-
• Z-1028-2015 · Dec 17, 2014 · Terminated
  Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling
• Z-1188-2014 · Nov 22, 2013 · Terminated
  G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are
• Z-1182-2014 · Nov 22, 2013 · Terminated
  4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devi
• Z-1187-2014 · Nov 22, 2013 · Terminated
  4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are
• Z-1181-2014 · Nov 22, 2013 · Terminated
  4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devi
• Z-1186-2014 · Nov 22, 2013 · Terminated
  4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are
• Z-1190-2014 · Nov 22, 2013 · Terminated
  G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line
• Z-1180-2014 · Nov 22, 2013 · Terminated
  4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, 22g x 1 needle, and Point-Lok needle safety device Arterial B
• Z-1189-2014 · Nov 22, 2013 · Terminated
  G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per

…and 16 more.