EHOB recalls WAFFLE Overlay (Item 1004EC) due to potential blood contamination in some lots. This may pose a risk of infection. Affected units were sold in specific hospital lots.
“EHOB WAFFLE Overlay Recall: Blood Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65014-ehob-waffle-overlay-recall-blood-contamination-risk. Based on FDA recall #Z-2640-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2640-2020%22&limit=1).
The FDA announced on June 9, 2020, that EHOB, Inc. is recalling the Expansion Control Overlay, Item No. 1004EC, due to potential blood contamination. This voluntary Class II recall affects 173 units distributed nationwide.
How to tell if you have it
Brand: EHOB
Product: Expansion Control Overlay, Item No. 1004EC
Lot code: 93649FA
The hazard
A quality control inspection observed that a portion of the lot may have been contaminated with blood.
Context
GovInfoNow's records show EHOB, Inc. has two other recalls on record since January 19, 2020. On April 19, 2021, the company recalled the EHOB Econocare Plus Waffle Overlay due to a risk of contamination from dried bodily fluids. On January 19, 2020, EHOB Econocare Plus Overlays were recalled for the risk of blood contamination in some products.
How to tell if you have this one
Check for the lot number 93649FA on the product. The WAFFLE Overlay is used in hospitals for patient transfers and mobility assistance.
Brand
EHOB
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Contamination
Inspect the product for signs of blood contamination. If present, stop using it immediately.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2640-2020 (June 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2640-2020 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.