Z-1449-2022Class II

Aesculap Sterile disposable fleece drape

Name: Z-1449-2022 Aesculap Sterile disposable fleece drape
Creator: Aesculap Implant Systems LLC
Published: 2019-10-01
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2019-10-01 / Terminated / root cause: packaging

FDA source

Aesculap Implant Systems LLC began a recall of Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R on 2019-10-01. FDA classified it as Class II and gives the reason as "Packaging seal integrity not validated resulting in a lack of sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1449-2022
Classification: Class II
Status: Terminated
Initiated: 2019-10-01
Posted: 2022-07-22
Terminated: 2024-06-06
Recalling firm: Aesculap Inc
Product: Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Product code: PUI Drape, Surgical, Exempt
Reason for recall: Packaging seal integrity not validated resulting in a lack of sterility assurance.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Recall notice issued October 1, 2019 via letter mailed USPS certified mail with return receipt. Customers are to review inventory, return affected product and the acknowledgement form. For questions contact (800) 282-9000 or email: [email protected]
Quantity in commerce: 4500 pieces
Distribution: United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI
Product codes and lots: UDI-DI (GTIN): 04038653067862, lots 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1449-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1449-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-21

Product code PUI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)