NAMICRecalls & reported problems across all models
Medline Industries, Inc. · 667 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
22 open recalls name at least one NAMIC model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 229
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 22
We found 667 models of NAMIC by Medline Industries, Inc. in the FDA's device registry (GUDID). Together they are named in 229 adverse event reports in the FDA's MAUDE database, received between Nov 3, 2020 and Sep 30, 2026 — classified as 1 injury, 228 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (72 reports).
22 FDA recall records name at least one of these models by its device identifier, 22 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
NAMIC recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 24, 2026Class IOpen, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2147-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 24, 2026Class IOpen, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2145-2026 · Root cause: Under Investigation by firm · names 156 of these models · Recall details · FDA record ↗
- Mar 24, 2026Class IOpen, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2144-2026 · Root cause: Under Investigation by firm · names 21 of these models · Recall details · FDA record ↗
- Mar 24, 2026Class IOpen, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2142-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 24, 2026Class IOpen, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2141-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 24, 2026Class IOpen, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2140-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 24, 2026Class IOpen, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2139-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 24, 2026Class IOpen, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2138-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Feb 27, 2026Class IOpen, Classified
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-1724-2026 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗
- Feb 27, 2026Class IOpen, Classified
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-1718-2026 · Root cause: Under Investigation by firm · names 434 of these models · Recall details · FDA record ↗
- Feb 27, 2026Class IOpen, Classified
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-1713-2026 · Root cause: Under Investigation by firm · names 6 of these models · Recall details · FDA record ↗
- Feb 27, 2026Class IOpen, Classified
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-1712-2026 · Root cause: Under Investigation by firm · names 17 of these models · Recall details · FDA record ↗
- Feb 25, 2026Class IIOpen, Classified
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Z-1836-2026 · Root cause: No Marketing Application · names 46 of these models · Recall details · FDA record ↗
- Feb 25, 2026Class IIOpen, Classified
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Z-1835-2026 · Root cause: No Marketing Application · names 2 of these models · Recall details · FDA record ↗
- Feb 12, 2025Class IIOpen, Classified
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Z-1431-2025 · Root cause: Process change control · names 19 of these models · Recall details · FDA record ↗
- Feb 12, 2025Class IIOpen, Classified
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Z-1430-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Feb 12, 2025Class IIOpen, Classified
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Z-1429-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Feb 12, 2025Class IIOpen, Classified
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Z-1428-2025 · Root cause: Process change control · names 2 of these models · Recall details · FDA record ↗
- Dec 16, 2024Class IOpen, Classified
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
Z-0765-2025 · Root cause: Under Investigation by firm · names 21 of these models · Recall details · FDA record ↗
- Dec 16, 2024Class IOpen, Classified
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
Z-0764-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 12, 2024Class IIOpen, Classified
Products have a lack of sterility assurance.
Z-1807-2024 · Root cause: Process control · Recall details · FDA record ↗
- Mar 12, 2024Class IIOpen, Classified
Products have a lack of sterility assurance.
Z-1806-2024 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗
Most reported NAMIC problems
Device problems
- Connection Problem72
- Loose or Intermittent Connection64
- Detachment of Device or Device Component22
- Fluid/Blood Leak18
- Break8
- Decoupling7
- Crack6
- Incomplete or Inadequate Connection6
Patient problems
- No Clinical Signs, Symptoms or Conditions204
- Insufficient Information20
- Myocardial Infarction2
- Air Embolism1
- Exposure to Body Fluids1
- Hemodynamic instability1
- Laceration(s)1
- Ventricular Fibrillation1
NAMIC models
667 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- NAMIC 60010508Cardiovascular procedure kit4 recalls0 reports
- NAMIC 60033123Cardiovascular procedure kit4 recalls0 reports
- NAMIC 60040273Cardiovascular procedure kit4 recalls0 reports
- NAMIC 60161954Cardiovascular procedure kit3 recalls1 report
- NAMIC 60010195Cardiovascular procedure kit3 recalls0 reports
- NAMIC 60010468Cardiovascular procedure kit3 recalls0 reports
- NAMIC 60080349Cardiovascular procedure kit3 recalls0 reports
- NAMIC 60130506Cardiovascular procedure kit3 recalls0 reports
- NAMIC 60132238Cardiovascular procedure kit3 recalls0 reports
- NAMIC 60140589Cardiovascular procedure kit3 recalls0 reports
- NAMIC 60184001Cardiovascular procedure kit3 recalls0 reports
- NAMIC 60192012Cardiovascular procedure kit3 recalls0 reports
- NAMIC 60220488Cardiovascular procedure kit3 recalls0 reports
- NAMIC 60232091Cardiovascular procedure kit3 recalls0 reports
- NAMIC 65012819Cardiovascular procedure kit3 recalls0 reports
- NAMIC 65040421Cardiovascular procedure kit3 recalls0 reports
- NAMIC 650104611Cardiovascular procedure kit3 recalls0 reports
- NAMIC 60131554Cardiovascular procedure kit2 recalls5 reports
- NAMIC 60161135Cardiovascular procedure kit2 recalls3 reports
- NAMIC 60230373Cardiovascular procedure kit2 recalls2 reports
- NAMIC 60013001Cardiovascular procedure kit2 recalls1 report
- NAMIC 60138301Cardiovascular procedure kit2 recalls1 report
- NAMIC 60160641Cardiovascular procedure kit2 recalls1 report
- NAMIC 60011045Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60012911Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60013101Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60013112Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60020323Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60022673Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60030817Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60031245Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60032681Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60033011Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60034644Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60035977Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60040424Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60041268Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60050097Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60050183Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60060387Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60062021Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60070435Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60070582Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60071232Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60071743Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60071822Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60080085Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60080716Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60081001Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60081168Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60090078Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60090542Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60091111Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60100071Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60100254Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60100313Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60100338Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60100439Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60100701Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60101773Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60110273Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60120693Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60121817Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60130124Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60130318Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60131208Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60131324Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60131815Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60132021Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60132653Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60137438Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60140015Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60140101Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60160536Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60161062Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60162156Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60163241Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60181531Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60182137Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60183233Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60183662Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60185432Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60190076Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60190947Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60191312Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60193811Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60195202Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60195751Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60196212Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60200421Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60200434Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60210014Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60210047Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60220468Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60230148Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60231052Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60620932Cardiovascular procedure kit2 recalls0 reports
- NAMIC 60620973Cardiovascular procedure kit2 recalls0 reports
- NAMIC 65010037Cardiovascular procedure kit2 recalls0 reports
- NAMIC 65138881Cardiovascular procedure kit2 recalls0 reports
Recent NAMIC adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955109 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952760 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952457 ↗MalfunctionSep 30, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952285 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952232 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952107 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951910 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951363 ↗MalfunctionSep 30, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951209 ↗MalfunctionSep 30, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951028 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950791 ↗MalfunctionSep 30, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950767 ↗MalfunctionSep 30, 2026Decoupling
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950669 ↗MalfunctionSep 30, 2026Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950546 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that "The team went through almost all of them in one day due to it leaking air out of the top of them. Difficult time filling the buritrol. It was making a hissing sound."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950419 ↗
Other Medline Industries, Inc. products
- Centurion Medical Products Corp52 models · 10 reports · 32 recalls
- CURAD85 models · 295 reports · 4 recalls
- HUDSON RCI30 models · 190 reports · 2 recalls
- Excelsior8 models · 47 reports · 3 recalls
- BAUSCH and LOMB6 models · 1 reports · 2 recalls
- Medline ReNewal18 models · 34 reports · 1 recall
- Guardian15 models · 77 reports
- MEDLINE UNITE10 models · 9 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page