CLASS II ONGOING Device recall · Reported 18 Mar 2026 · FDA Enforcement Report
Medline Medcrest Surgical Gowns recalled by Medline Industries
Medline Industries is recalling Medline Medcrest Surgical Gowns: MDTGXC4J5XL Dbq-gown,Surg,Xalt,L4, Crtcl Cvr, Grn, 5, distributed nationwide in the US. The recall was initiated on 28 Jan 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1563-2026
- FDA event ID
- 98430
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Jan 2026
- FDA classified
- 12 Mar 2026
- Reported
- 18 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 28 Jan 2026 | Recall initiated by company | |
| 12 Mar 2026 | Classified by FDA | +43 days |
| 18 Mar 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI (each/case) 10197344014002 20197344014009 10888277189188 40888277189189 10884389189191 40884389189192 10884389193297 40884389193298 10888277189218 40888277189219 10884389189221 40884389189222 10193489040111 20193489040118 10884389189221 40884389189222 10193489021820 20193489021827 All lots affected
Where was it sold?
Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98430| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medline Surgical Drapes: MDTBTCS6070GN recalled by Medline Industries | Medline Industries | Other | Nationwide |
More recalls from Medline Industries
All 686| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |