Lower risk Medical device recall · FDA · Published January 15, 2021

Medline STAT-Site Controls Recall: Shipment Compromise Risk

Medline recalls specific lots of STAT-Site B-HB controls due to shipment compromise. Affected units may have contamination; contact for replacement.

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

🇺🇸 FDA recall #Z-1135-2021Medical device Medline ›

Lower-risk recall

Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.

Take action

Contact the company

Recalling firmMedline Industries Inc3 Lakes Dr · Northfield, IL 60093-2753

✎ GovInfoNow plain-language explainer

Medline is recalling specific batches of STAT-Site B-HB control kits because they were compromised during shipping. This could lead to inaccurate lab results if used. Read more at govinfonow.com/recall/63422-medline-stat-site-controls-recall-shipment-compromise-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63422-medline-stat-site-controls-recall-shipment-compromise-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1135-2021

Cite this page

“Medline STAT-Site Controls Recall: Shipment Compromise Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63422-medline-stat-site-controls-recall-shipment-compromise-risk. Based on FDA recall #Z-1135-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1135-2021%22&limit=1).

The FDA announced on Jan. 15, 2021, that Medline Industries Inc. is recalling specific lots of STAT-Site Controls due to product compromise during shipment. The agency issued recall number Z-1135-2021 for the Class III medical device.

How to tell if you have it

Brand: Medline
Product: S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH
Model Number: S-O303000
Lot/Batch Numbers: 154950, 154590, 158668, 159370, 192532, 192891, 19365, 200831
Quantity: 46 units

The hazard

The FDA stated the STAT-Site Controls (Low and High) were compromised during shipment. The product is intended for the quantitative determination of ketone body -Hydroxybutyrate in serum or plasma.

Context

GovInfoNow's records show Medline Industries Inc has 48 other recalls on record since Sept. 25, 2015. Other recent recalls include a July 21, 2022 recall of Chest Tube Kits for non-sterile tape in sterile components and an Oct. 27, 2021 recall of EVLP Kits for expired NaCl bags. Additional similar product recalls occurred on July 10, 2026, involving Convenience Kits and C-Section Kits due to contaminated components.

How to tell if you have this one

Check for batch numbers: 154950, 154590, 158668, 159370, 192532, 192891, 19365, or 200831. The product is labeled as STAT-Site B-HB, 2X3ML, 1Low, 1High controls for lab use.

Brand
Medline
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Batch Numbers
Verify the batch number on the product label matches the listed numbers: 154950, 154590, 158668, 159370, 192532, 192891, 19365, or 200831.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

FDA distribution: “US Nationwide distribution in the states of MS, OH, IL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Illinois, Mississippi, Ohio.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

Jan 15, 2021Firm started the recall
Feb 19, 2021FDA classified it Class III
Mar 3, 2021Published in FDA’s Enforcement Report
Jan 9, 2023FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of injury from using this product?

The recall is due to potential contamination, not a physical hazard like injury. The risk is to lab accuracy, not safety.

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Link to this recall

<a href="https://govinfonow.com/recall/63422-medline-stat-site-controls-recall-shipment-compromise-risk">Medline STAT-Site Controls Recall: Shipment Compromise Risk (GovInfoNow)</a>

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-1135-2021 (January 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1135-2021 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.