Medline Medcrest Surgical Gowns recallZ-1563-2026 · 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-1563-2026
- Status
- Open, Classified
- Initiated by the company
- Jan 28, 2026
- Posted by the FDA
- Mar 12, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 104,004
- Product code
- FYA
- FDA submissions
- K982694
- Distribution
- Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.
Product description
Medline 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,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL
Code information (models, lots, serial numbers)
UDI-DI (each/case) 10197344014002 20197344014009 10888277189188 40888277189189 10884389189191 40884389189192 10884389193297 40884389193298 10888277189218 40888277189219 10884389189221 40884389189222 10193489040111 20193489040118 10884389189221 40884389189222 10193489021820 20193489021827 All lots affected
Devices named in this recall
8 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline MDTGXC4JXLMedline Industries, Inc. · GOWN, SURGICAL1 recall0 reports
- Medline MDTGXC4JLMedline Industries, Inc. · GOWN, SURGICAL1 recall0 reports
- Medline MDTZ1000893AJMedline Industries, Inc. · Gown, Surgical1 recall0 reports
- Medline MDTGXP4JXXLMedline Industries, Inc. · Gown, Surgical1 recall0 reports
- Medline MDTGXC4J5XLMedline Industries, Inc. · Gown, Surgical1 recall0 reports
- Medline MDTGXP4JXLMedline Industries, Inc. · GOWN, SURGICAL1 recall0 reports
- Medline MDTGXC4JXXLMedline Industries, Inc. · GOWN, SURGICAL1 recall0 reports
- Medline MDTGXP4JLMedline Industries, Inc. · GOWN, SURGICAL1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98430).
- Z-1564-2026 · Open, ClassifiedMedline 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…
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.
How recalls are matched to devices · Editorial policy · Report an error on this page