Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-1563-2026 · Posted 2026-03-12

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeFYA
Date Initiated2026-01-28
Product Quantity104,004

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.

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982694MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPESMedline Industries, Inc. · 1998-12-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑