FDA Device recall Z-1564-2026
Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTD…
- FDA Device
- Class II
- ongoing
- Published 2026-03-18
On 2026-03-18 the FDA classified a Class II recall of Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTD… by Medline Industries, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1564-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-28 |
| Published | 2026-03-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline 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,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT
Reason
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.
Identifiers
| code_info | UDI-DI (each/case) 10193489036961 20193489036968 10193489036978 20193489036975 10193489040098 20193489040095 1019348903…UDI-DI (each/case) 10193489036961 20193489036968 10193489036978 20193489036975 10193489040098 20193489040095 10193489036954 20193489036951 10193489036985 20193489036982 All lots affected |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1564-2026%22
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