Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q; 3) DIVA PACK, Kit SKU DYNJ04811O; 4) DA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S; 5) MH ROBOTICS PACK, Kit SKU DYNJ50880L; 6) DELNOR LAPAROSCOPIC GYN PACK, Kit SKU DYNJ82244B; 7) ROBOT PACK, Kit SKU DYNJ82761B; 8) GENERAL ROBOTICS PACK, Kit SKU DYNJT4964.
Why it was recalled
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Medline Kit SKU DYNJ0395022O: UDI/DI 10195327634827 (EA) 40195327634828 (CS), Lot Number 25KME682; Medline Kit SKU DYNJ0415776Q: UDI/DI 10198459566806 (EA) 40198459566807 (CS), Lot Number 25KMH125; Medline Kit SKU DYNJ04811O: UDI/DI 10198459440953 (EA) 40198459440954 (CS), Lot Number 25KMD772; Medline Kit SKU DYNJ44864S: UDI/DI 10195327127626 (EA) 40195327127627 (CS), Lot Number 25LMA115; Medline Kit SKU DYNJ50880L: UDI/DI 10198459388002 (EA) 40198459388003 (CS), Lot Number 25LMA516; Medline Kit SKU DYNJ82244B: UDI/DI 10198459344053 (EA) 40198459344054 (CS), Lot Number 25KMF328; Medline Kit SKU DYNJ82761B: UDI/DI 10198459039232 (EA) 40198459039233 (CS), Lot Number 25LMA391; Medline Kit SKU DYNJT4964: UDI/DI 10198459460098 (EA) 40198459460099 (CS), Lot Number 25KMJ341.
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide distribution.
Recall record
- Recalling firm
- Medline Industries, LP
- Product type
- Devices
- Recall number
- Z-1197-2026
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Origin
- Northfield, IL
- Recall initiated
- 2025-12-12
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1197-2026 · Source: openFDA enforcement.