Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RES
Summary
The FDA issued a Class II for Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X by Medline Industries, LP. Reason: Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting .
Details
Source
Device Recall
External ID
Z-1564-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI-DI (each/case) 10193489036961 20193489036968 10193489036978 20193489036975 10193489040098 20193489040095 10193489036954 20193489036951 10193489036985 20193489036982 All lots affected
Quantity Affected: 23,568
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-28
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 190 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1564-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29