CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report
Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled
Medline Industries is recalling Medline Drape C-section Fen Clr Screen W, Medline Product Number, distributed nationwide in the US. The recall was initiated on 9 Sep 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-0271-2027
- FDA event ID
- 99960
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Sep 2026
- FDA classified
- 22 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Sep 2026 | Recall initiated by company | |
| 22 Oct 2026 | Classified by FDA | +43 days |
| 28 Oct 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
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
Product as listed by the FDA
MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108
Where it was distributed
Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
Questions about this recall
Why was it recalled?
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
Which lots are affected?
UDI/DI 10888277668843 (each) 20888277668840 (case), Lot numbers: 45025120094, 45025120253
Where was it sold?
Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
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 3 Nov 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
11 other products · FDA event 99960This product is part of a recall event; the main page for the event is Medline medical convenience kits labeled as: Hip Scope Pack recalled.
More recalls from Medline Industries
All 738| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: C-section Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |
Other Other Medical Devices recalls
All 13,950| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: C-section Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |