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Lower risk Medical device recall · FDA · Published August 20, 2024

Baxter EXACTAMIX Inlet Recall: Particulate Risk in Pharmaceutical Compounding Devices

Baxter recalls EXACTAMIX Inlet syringes (H938176) due to particulate matter in the sterile fluid path. Affected units sold with ExactaMix and ExactaMix Pro compounders. Contact Baxter for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3085-2024Medical deviceBaxter ›
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Contact the company

Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer

Baxter is recalling EXACTAMIX Inlet syringes (product code H938176) used in pharmaceutical compounding devices because they may contain particulate matter in the sterile fluid path. This could lead to contamination of compounded medications, posing a risk to patient safety. Read more at govinfonow.com/recall/54193-baxter-exactamix-inlet-recall-particulate-risk-in-pharmaceutical-compounding-devices.

Source Summary by GovInfoNow · govinfonow.com/recall/54193-baxter-exactamix-inlet-recall-particulate-risk-in-pharmaceutical-compounding-devices · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3085-2024

Cite this page

“Baxter EXACTAMIX Inlet Recall: Particulate Risk in Pharmaceutical Compounding Devices.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54193-baxter-exactamix-inlet-recall-particulate-risk-in-pharmaceutical-compounding-devices. Based on FDA recall #Z-3085-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3085-2024%22&limit=1).

Baxter Healthcare Corporation voluntarily recalled Baxter EXACTAMIX Inlet, Vented, Syringe Inlet (REF H938176) for use in a pharmaceutical compounding device, according to the FDA on August 20, 2024. The product contains particulate matter within the sterile fluid path tubing before use.

How to tell if you have it

  • Brand: Baxter
  • Product: Baxter EXACTAMIX Inlet, Vented, Syringe Inlet
  • REF: H938176
  • UDI/DI: 00085412475813
  • Lot Numbers: 803807 and lower

The hazard

Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (Product Codes H938173, H938174, H938175, H938176) used with ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging components, including within the sterile fluid path tubing, before use.

Context

GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since September 2, 2015. Other recent recalls of similar products include Medline Medical Kits Recall: Particulate Risk in Fluid Path (March 24, 2026) and Medline Namic Preceptor Manifold Recall: Particulate Risk in Blood Pressure Transducers (March 24, 2026).

How to tell if you have this one

Check for product codes H938173, H938174, H938175, or H938176 on the syringe packaging. These units were sold with UDI/DI 00085412475813 and lot numbers 803807 and lower.

  • Brand
    Baxter
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    Worldwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-3082-2024Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device; UDI/DI 00085412475783, Lot Numbers: 803806 and lower3,580,283 units
Z-3083-2024Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device; UDI/DI 00085412475790, Lot Numbers: 803799 and lower1,548,782 units
Z-3084-2024Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device; UDI/DI 00085412475806, Lot Numbers: 803808 and lower5,828,540 units
Z-3085-2024Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device; UDI/DI 00085412475813, Lot Numbers: 803807 and lower2,140,046 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Codes

    Identify if your syringe has product codes H938173, H938174, H938175, or H938176.

  2. Contact Baxter

    Reach out to Baxter Healthcare Corporation for further instructions on handling recalled units.

How this recall unfolded

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: Aug 20, 202412. FDA classified it Class I: Sep 19, 202423. Published in FDA’s Enforcement Report: Sep 25, 202432024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Other Baxter recalls

Baxter Healthcare Corporation recalls Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5)
April 7, 2025Baxter Healthcare Corporation recalls Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
December 20, 2024Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
October 21, 2024Baxter Healthcare Corporation recalls Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A,
September 12, 2024

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3085-2024 (August 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3085-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA