Device recall
MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B.
- Recall number
- Z-0281-2027
- 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
- 56 kits
- Code info
- Medline Kit Number/SKU DYNJ64103C, UDI/DI 10198459221828 (each) 40198459221829 (case), Lot Number 26ABI361; Medline Kit Number/SKU DYNJ64103C, UDI/DI 10198459221828 (each) 40198459221829 (case), Lot Number 25KBD396; Medline Kit Number/SKU DYNJ64155B, UDI/DI 10198459146954 (each) 40198459146955 (case), Lot Number 26ABP213; Medline Kit Number/SKU DYNJ64155B, UDI/DI 10198459146954 (each) 40198459146955 (case), Lot Number 25LBJ299.
- Distribution
- Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States