Recall Ledger

MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS recall (Medline Industries, LP)

Medical deviceClass IIOngoing

Summary: Medline Industries, LP is recalling 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.. Reason: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

What is being recalled

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.

Why

Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE. (states named: California)

How to tell if yours is affected

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.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-0277-2027
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedSeptember 9, 2026
ReportedOctober 28, 2026
CompanyMedline Industries, LP
Company locationNorthfield, IL, United States
Initiated byVoluntary: Firm initiated
Quantity545 units

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