Covidien Vistec X-Ray Sponges Recall: Possible Blood Contamination Risk
Covidien is recalling two lots of X-ray detectable sponges due to possible contamination with human blood during manufacturing. These sponges are used for internal bleeding control and may pose a risk if contaminated.
Lower-risk recall
Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.
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What happened, in plain English
Covidien is recalling two specific lots of X-ray detectable sponges because they might have been contaminated with human blood during production. This could be a risk if the sponges are used in medical procedures. Read more at govinfonow.com/recall/73404-covidien-vistec-x-ray-sponges-recall-possible-blood-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73404-covidien-vistec-x-ray-sponges-recall-possible-blood-contamination-risk · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0534-2018
Cite this page
“Covidien Vistec X-Ray Sponges Recall: Possible Blood Contamination Risk.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73404-covidien-vistec-x-ray-sponges-recall-possible-blood-contamination-risk. Based on FDA recall #Z-0534-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0534-2018%22&limit=1).
Why it’s dangerous
The sponges may have been contaminated with human blood during manufacturing and before final sterilization. This contamination could occur if the sponges are used in medical procedures without proper cleaning.
Who’s affected
Medical professionals and patients who use these sponges for internal bleeding control or medication application. Those with the specific lot numbers listed are most at risk.
How to tell if you have this one
Check the lot numbers: 17E121362 or 17E121262. These sponges are used for internal bleeding control and are visible under X-ray when saturated with blood.
- Brand
Covidien- Category
Medical device
What to do — step by step
Check Lot Numbers
Look for lot numbers 17E121362 or 17E121262 on the product packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 14 months 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-0534-2018 (July 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0534-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 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.