Z-1563-2026Class II

Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL...

Name: Z-1563-2026 Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL...
Creator: Medline Industries, LP
Published: 2026-01-28
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-01-28 / Open, Classified / root cause: labeling and UDI

FDA source

Medline Industries, LP began a recall of 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... on 2026-01-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1563-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-28
Posted: 2026-03-12
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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
Product code: FYA Gown, Surgical
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 104,004
Distribution: Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1563-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1563-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-12
Z-1564-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-12

Product code FYA

K982694Class IIMedline Medcrest Surgical Gowns and Surgical DrapesMedline Industries, Inc. / cleared 1998-12-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)