MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOT
Summary
The FDA issued a Class II for MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline K 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-0277-2027
Action Date
2026-10-28
Status
Ongoing
Category
device
Product Description
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.
Lot/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.
Quantity Affected: 545 units
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-0277-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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