Lower riskMedical device recall · FDA · Published October 1, 2019
Aesculap Sterile Fleece Drapes Recall: Packaging Seal Risk
Aesculap recalls sterile disposable fleece drapes (product code GA414) due to unverified packaging seals risking contamination. Affected units include specific lot numbers and shipping units.
Packaging seal integrity not validated resulting in a lack of sterility assurance.
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Contact the company
📍Recalling firmAesculap Implant Systems LLC3773 Corporate Pkwy · Center Valley, PA 18034-8217
✎ GovInfoNow plain-language explainer
Aesculap is recalling sterile disposable fleece drapes (product code GA414) because the packaging seals weren't properly validated, which could lead to contamination during medical procedures. This affects surgical drapes used in hospitals and clinics. Read more at govinfonow.com/recall/66937-aesculap-sterile-fleece-drapes-recall-packaging-seal-risk.
“Aesculap Sterile Fleece Drapes Recall: Packaging Seal Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66937-aesculap-sterile-fleece-drapes-recall-packaging-seal-risk. Based on FDA recall #Z-1449-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1449-2022%22&limit=1).
Aesculap Implant Systems LLC voluntarily recalled Aesculap Sterile disposable fleece drapes due to packaging seal integrity issues that may compromise sterility assurance, according to the FDA on 2019-10-01.
How to tell if you have it
Brand: Aesculap
Product: Aesculap Sterile disposable fleece drape
Product codes: GA414, SZ380R
UDI-DI (GTIN): 04038653067862
Lot codes: 551953371, 52024524, 52097698, 52172460, 52249972, 52340448
Quantity: 4500 pieces
Distribution: United States (CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA, WI)
The hazard
The recall involves packaging seal integrity not being validated, resulting in a lack of sterility assurance for the sterile disposable fleece drapes.
Context
GovInfoNow's records show Aesculap Implant Systems LLC has 26 other recalls on record since 2017-08-10. Other recent recalls include the Aesculap Brain Ventricles Implant Systems recall (2023-07-20), the Aesculap Surgical Needle Recall (2023-05-18), and the Aesculap Caiman Articulating D5/360MM recall (2023-03-21).
How to tell if you have this one
Check for product code GA414, individually packaged drapes with 50 pieces per shipping unit. Lot numbers include 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448.
Brand
Aesculap
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product code (GA414) and lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in 14 states.
Listed by the agency
Not listed
FDA distribution: “United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Georgia, Illinois, Indiana, Kentucky, Michigan, Nebraska, New York, North Carolina, Ohio, Rhode Island, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 4.7 years 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-1449-2022 (October 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1449-2022 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.