FDA recall, , Moderate risk
Medline Medcrest Surgical Gowns and Surgical Drapes
Medline Medcrest Surgical Gowns may experience premature delamination, which can cause brief delays in patient care and risk of infection.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP, of Northfield, Illinois, recalled Medline Medcrest Surgical Gowns and Medline Surgical Drapes because the fabric may experience premature delamination when using included laundering instructions.
Identifying a delaminated gown or drape in a surgical setting may result in a brief delay in patient care, and if a delaminated product is used and surgical strikethrough occurs, there may be a risk of infection.
The recall began January 28, 2026, and was added to the FDA's Enforcement Report on March 12, 2026, with distribution nationwide in the US and internationally to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medline Medcrest Surgical Gowns
- UDI-DI
- 10197344014002
- 20197344014009
- 10888277189188
- 40888277189189
- 10884389189191
- 40884389189192
- 10884389193297
- 40884389193298
- 10888277189218
- 40888277189219
- 10884389189221
- 40884389189222
- 10193489040111
- 20193489040118
- 10193489021820
- 20193489021827
- Lot code
- All lots affected
Medline Surgical Drapes
- UDI-DI
- 10193489036961
- 20193489036968
- 10193489036978
- 20193489036975
- 10193489040098
- 20193489040095
- 10193489036954
- 20193489036951
- 10193489036985
- 20193489036982
- Lot code
- All lots affected
Recall details
- Company began the recall
- Sold in
Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98430
- Recall numbers
- Z-1563-2026 to Z-1564-2026
All recalls from Medline Industries, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
