FDA-Device2026-10-22Class IIPACKAGING DEFECT
Medline surgical convenience kits recalled for difficult removal and adhesive residue
What this means
Four Medline medical convenience kits used in gynecological and abdominal surgeries are difficult to remove from patients and may leave adhesive residue on skin. The affected kits are Laparotomy GYN CDS, GYN Robotic PK-LF, TAH Pack, and Tubal Ligation RFD. About 545 units have been distributed worldwide.
- Check your facility's inventory for the affected kit numbers: CDS983529O, DYNJ52432M, DYNJ60646A, and DYNJ906291F
- Contact Medline for instructions on replacement or return of affected kits
- Review patient records if these kits were used and monitor for skin irritation or adhesive residue
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
545 units
Manufactured in
3 Lakes Dr, Northfield, Illinois, United States
Products
MEDLINE medical convenience kits labeled as:
1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O;
2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M;
3) TAH PACK, Medline Kit Number/SKU DYNJ60646A;
4) TUBAL LIGATION RFD, Medline Kit Number/SKU DYNJ906291F.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0277-2027More 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 tubal ligation surgical kit recalled for difficult removal and skin adhesive residue
- FDA-Device2026-10-22Medline C-section surgical drape recalled for difficult removal and skin adhesive residue
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