Z-1090-2026Class II

Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G

Name: Z-1090-2026 Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Creator: Medline Industries, LP
Published: 2025-12-16
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-12-16 / Open, Classified / root cause: design

FDA source

Medline Industries, LP began a recall of Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G on 2025-12-16. FDA classified it as Class II and gives the reason as "Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1090-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-16
Posted: 2026-01-14
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Product code: OKV Obstetrical Kit
Reason for recall: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Root cause tag: design
FDA root cause: Under Investigation by firm
Action: Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/16/2025 via email and USPS first class mail. The notice explained the issue, potential risk, and requested the following: "1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2.Please use the link and the information below to complete your response form. Please list the quantityof affected product you have in inventory on the form. Even if you do not have any affected productin inventory, please complete and submit the form. Website link: https://recalls.medline.comRecall Reference #: R-25-145-FGX5 Recall Code: 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4.If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]."
Quantity in commerce: 12 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1090-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1085-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-14
Z-1086-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-14
Z-1087-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-14
Z-1088-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-14
Z-1089-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-14
Z-1090-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-14

Product code OKV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)