FDA-Device2026-10-22Class IIPACKAGING DEFECT
Medline FETOSCOPY CDS-LF medical kit recalled for difficult removal and skin adhesive residue
What this means
Medline's FETOSCOPY CDS-LF medical convenience kit (Product Number CDS840215P) is difficult to remove from patients and may leave adhesive residue on the skin. The company has identified this issue affecting 10 kits distributed worldwide.
- If you have this kit in use, stop using it immediately.
- Contact Medline Industries for instructions on how to return or replace the affected kit.
- If a patient has experienced skin irritation or adhesive residue, consult a healthcare provider.
The agency's original wording
Hazard
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
Affected count
10 kits
Manufactured in
3 Lakes Dr, Northfield, Illinois, United States
Products
MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0272-2027More Medline recalls
- FDA-Device2026-10-22Medline medical convenience kits recalled for difficult removal and adhesive residue
- FDA-Device2026-10-22Medline sterile C-section surgical drape recalled for difficult removal and skin adhesive residue
- FDA-Device2026-10-22Medline medical convenience kits recalled for difficult removal and adhesive residue
- FDA-Device2026-10-22Medline surgical convenience kits recalled for difficult removal and adhesive residue
- FDA-Device2026-10-22Medline tubal ligation surgical kit recalled for difficult removal and skin adhesive residue
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