# FDA recall Z-1563-2026

> **Medline Industries, LP** · Class II · device recall initiated 2026-01-28.

## 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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1563-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-28
- **Report date:** 2026-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1563-2026

## Citation

> AI Analytics. FDA recall Z-1563-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1563-2026. Source: US FDA. Licensed CC0.

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