Device recall
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.
- Recall number
- Z-0277-2027
- Event id
- 99960
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medline Industries, LP
- Report date
- Oct 28, 2026
- Posted
- Oct 22, 2026
- Initiated
- Sep 9, 2026
- Center classification date
- Oct 22, 2026
- Product code
- PUI
- Device type
- Drape, Surgical, Exempt
- Reason
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- Root cause
- Under Investigation by firm
- Quantity
- 545 units
- Code info
- Medline kit number/SKU CDS983529O, UDI/DI 10198459603464 (each) 40198459603465 (case), Lot Number CDS983529O; Medline kit number/SKU CDS983529O, UDI/DI 10198459603464 (each) 40198459603465 (case), Lot Number CDS983529O; Medline kit number/SKU DYNJ52432M, UDI/DI 10198459508035 (each) 40198459508036 (case), Lot Number DYNJ52432M; Medline kit number/SKU DYNJ52432M, UDI/DI 10198459508035 (each) 40198459508036 (case), Lot Number DYNJ52432M; Medline kit number/SKU DYNJ60646A, UDI/DI 10198459363658 (each) 40198459363659 (case), Lot Number DYNJ60646A; Medline kit number/SKU DYNJ60646A, UDI/DI 10198459363658 (each) 40198459363659 (case), Lot Number DYNJ60646A; Medline kit number/SKU DYNJ906291F, UDI/DI 10198459419591 (each) 40198459419592 (case), Lot Number DYNJ906291F; Medline kit number/SKU DYNJ906291F, UDI/DI 10198459419591 (each) 40198459419592 (case), Lot Number DYNJ906291F.
- Distribution
- Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States