Medline Surgical Drapes recallZ-1564-2026 · Medline Industries, LP · initiated Jan 28, 2026
Open, Classified
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 Medline Industries, LP 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
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.
FDA root cause category: Labeling Change Control
What the company is doing
On January 28, 2026, the firm notified customers of the issue through Urgent Medical Device Recall letters. Users were provided with updated laundering instructions and general inspection guidelines.
Recall details
- Recall number
- Z-1564-2026
- Status
- Open, Classified
- Initiated by the company
- Jan 28, 2026
- Posted by the FDA
- Mar 12, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 23,568
- Product code
- PUI
- Distribution
- Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.
Product description
Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT
Code information (models, lots, serial numbers)
UDI-DI (each/case) 10193489036961 20193489036968 10193489036978 20193489036975 10193489040098 20193489040095 10193489036954 20193489036951 10193489036985 20193489036982 All lots affected
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline MDTMAYOXGNMedline Industries, Inc. · Drape, Surgical1 recall0 reports
- Medline MDTBTCS6070GNMedline Industries, Inc. · Drape, Surgical1 recall0 reports
- Medline MDTBTCS6090GNMedline Industries, Inc. · Drape, Surgical1 recall0 reports
- Medline MDTZ1003656GNMedline Industries, Inc. · Drape, Surgical1 recall0 reports
- Medline MDTDXUNDBGNMedline Industries, Inc. · Drape, Surgical1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98430).
- Z-1563-2026 · Open, ClassifiedMedline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,…
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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