Aesculap Sterile disposable fleece drape, Product code:… recallZ-1449-2022 · Aesculap Implant Systems LLC · initiated Oct 1, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aesculap Implant Systems LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Packaging seal integrity not validated resulting in a lack of sterility assurance.
FDA root cause category: Package design/selection
What the company is doing
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]
Recall details
- Recall number
- Z-1449-2022
- Status
- Terminated
- Initiated by the company
- Oct 1, 2019
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 4500 pieces
- Product code
- PUI
- Distribution
- United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI
Product description
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 04038653067862, lots 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AESCULAP GA414Aesculap AG · Drape, surgical, exempt1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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