Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CR
FDA device recall Z-1563-2026 · posted 2026-03-12 · Open, Classified
Recall details
- Recalling firm
- Medline Industries, LP
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- FYA
- Quantity affected
- 104,004
- Distribution
- Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.
- Date initiated
- 2026-01-28
- Date posted
- 2026-03-12
- Location
- Northfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES (K982694) | Medline Industries, Inc. | 1998-12-14 |