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U.S. Department of Health and Human Services

Class 2 Device Recall Medline convenience kits

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 Class 2 Device Recall Medline convenience kitssee related information
Date Initiated by FirmSeptember 24, 2026
Date PostedNovember 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0420-2027
Recall Event ID 100112
Product Classification Hysterectomy kit - Product Code OJF
ProductMedline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes ABDOMINAL HYSTERECTOMY DYNJT8877 LAPAROSCOPIC HYSTERECTOMY DYNJ900244J LAVH DYNJ903392L PELVIC/LAVH/TUBALIGATION T DYNJ910662B WPH MAJOR VAGINAL PACK DYNJ89783 DAVINCI HYSTERECTOMY CDS CDS985344F GYN ABDOMINAL CDS CDS982654L GYN LAP HYSTERECTOMY CDS CDS982662Q LAVH DYNJ909742B
Code Information DYNJT8877 UDI-DI 10198459764486 Lots 26EBB204 26GBP480 DYNJ900244J UDI-DI 10198459478727 Lots 26ABB104 26CBN466 DYNJ903392L UDI-DI 10198459522758 Lots 25KBE512 25LBA207 DYNJ910662B UDI-DI 10198459477430 Lot 25LBF442 DYNJ89783 UDI-DI 10198459289323 Lots 25LBB743 26ABN735 CDS985344F UDI-DI 10195327312565 Lots 25LBG617 26ABH355 26ABJ895 CDS982654L UDI-DI 10195327306830 Lot 26EBN087 CDS982662Q UDI-DI 10195327306793 Lots 25LBF560 26ABD832 26ABP323 DYNJ909742B UDI-DI 10198459107221 Lots 25LBD208 26ABO287
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
800-633-5463
Manufacturer Reason
for Recall		Convenience kits contain additional product codes and lots of recalled CliniClean Pericare Wipes identified by manufacturer. Wipes may be contaminated with a lubricant used in the manufacturing process. Use of affected wipes may cause localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare may increase the risk of localized infection or catheter-associated urinary tract infection.
FDA Determined
Cause 2		Process change control
ActionThis is an update to a previously issued letter due to the manufacturer/supplier identifying additional lots of affected product. On September 24, 2026, customers were notified of the additional products and lots affected. Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a sticker indicating to remove the affected component and replace it with product from supply. No kits are to be returned.
Quantity in Commerce7,043 kits
DistributionUS Nationwide distribution in the states of AL, AR, CA, FL, GA, IL, IN, LA, MA, MN, MO, MS, MT, NC, NE, NV, NY, OH, OK, RI, SC, TN, TX, WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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