OriGen Biomedical 3/8" FloPump Recall: Expired Product Risk
OriGen Biomedical recalls expired 3/8" FloPump pumps. These sterile medical devices may not be safe for use after expiration. Consumers should check product lot numbers and contact the company for details.
Lower-risk recall
The firm has become aware that they have distributed product that was expired.
Contact the company
What happened, in plain English
OriGen Biomedical is recalling expired 3/8" FloPump medical pumps. Using expired sterile medical devices can lead to infections or other health risks if the product is no longer safe. Read more at govinfonow.com/recall/67614-origen-biomedical-3-8-flopump-recall-expired-product-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/67614-origen-biomedical-3-8-flopump-recall-expired-product-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0318-2021
Cite this page
“OriGen Biomedical 3/8" FloPump Recall: Expired Product Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67614-origen-biomedical-3-8-flopump-recall-expired-product-risk. Based on FDA recall #Z-0318-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0318-2021%22&limit=1).
Why it’s dangerous
Expired medical products can lose effectiveness and safety over time. Sterile devices that are past their expiration date may not be safe for use, increasing the risk of infections or other complications.
Who’s affected
Medical patients who use these expired sterile pumps for prescription treatments. Those with the specific lot number 042417-5045 are most at risk.
How to tell if you have this one
Check for the product name '3/8" FloPump', model 'REF 6400S', and lot number 042417-5045. The product is sterile and intended for prescription use only.
- Brand
OriGen Biomedical- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for the lot number 042417-5045 on the pump's packaging or label.
Where it went and when
Where it was distributed
Distributed in Texas.
FDA distribution: “US: TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0318-2021 (June 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0318-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.