ICU Medical Z2587Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709027008), received between Apr 29, 2026 and Jun 21, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

187 other recalls cover devices cleared under the same FDA submission (K964435); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 12, 2026Class IIOpen, Classified

   Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

   Z-3163-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2026Contamination

  AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING THE PRODUCT "102-INCH 10 DROP PRIMARY SET, 2 CLAVE, REMV 3 GANG 4-WAY STOPCOCKS, 3 MICROCLAVE, ROTATING LUER, 2 EXT," REPORTING THAT THERE WERE BLACK SPECKS IN THE DRIP CHAMBERS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572304 ↗
• MalfunctionJun 8, 2026Particulates

  THE EVENT INVOLVED A '102" 10 DROP PRIMARY SET W/2 CLAVE®, REMV 3 GANG 4-WAY STOPCOCKS, 3 MICROCLAVE®, ROTATING LUER, 2 EXT THAT ONE TUBING HAS BLACK SPECK IN THE DRIP CHAMBER, THE OTHER SET HAD THE SPECK IN THE DRIP CHAMBER. AT SOME POINT, THE SPECK WAS NO LONGER VISIBLE IN THE DRIP CHAMBER OR VISIBLE AREAS OF TUBING IN THE SECOND SET. THE CONCERN WAS MIGRATION OF THE PARTICLE INTO AN AREA OF TUBING THAT WAS NOT VISIBLE. THERE WERE SEVERAL PORTIONS OF TUBING THAT WERE NOT VISIBLE OR WERE OBSCURED, THE EVENT OCCURRED WHILE PERFORMING VISUAL INSPECTION, THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437146 ↗
• MalfunctionApr 29, 2026Fluid/Blood Leak

  THE FOLLOWING MEDICAL DEVICE '102" 10 DROP PRIMARY SET W/2 CLAVE®, REMV 3 GANG 4-WAY STOPCOCKS, 3 MICROCLAVE®, ROTATING LUER, 2 EXT' REPORTEDLY LEAKED UNSPECIFIED ANESTHESIA ON AN UNSPECIFIED DATE. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033033 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.

• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
• Z-1721-2022 · Aug 1, 2022 · Open, Classified
  6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
• Z-0956-2021 · Dec 2, 2020 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
• Z-0957-2021 · Dec 2, 2020 · Terminated
  7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
• Z-0958-2021 · Dec 2, 2020 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
• Z-0955-2021 · Dec 2, 2020 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
• Z-0198-2021 · Jul 6, 2020 · Terminated
  107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(
• Z-0239-2021 · Jul 6, 2020 · Terminated
  APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(1
• Z-0221-2021 · Jul 6, 2020 · Terminated
  83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case. UDI:(01)10887709089508(17)250101(30)25(10)45
• Z-0219-2021 · Jul 6, 2020 · Terminated
  113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per
• Z-0233-2021 · Jul 6, 2020 · Terminated
  139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)1088
• Z-0188-2021 · Jul 6, 2020 · Terminated
  10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri-Connector, NanoClave T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 unit per pouch, 50 multivac pouche
• Z-0184-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI: (01)10887709051031(
• Z-0218-2021 · Jul 6, 2020 · Terminated
  126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01

…and 172 more.