MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PAC
Summary
The FDA issued a Class II for MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit N by Medline Industries, LP. Reason: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin..
Details
Source
Device Recall
External ID
Z-0281-2027
Action Date
2026-10-28
Status
Ongoing
Category
device
Product Description
MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B.
Lot/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.
Quantity Affected: 56 kits
Reason for Recall
Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
Distribution
Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-09
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 187 device recalls issued in the same week, part of 480 device-related FDA actions this month.
Medline Industries, LP has 617 FDA actions in our database, including 589 recalls and 28 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 617 FDA actions in our database, including 589 recalls and 28 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0281-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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