CLASS II ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report
Medline medical procedure convenience kits labeled as recalled
Medline Industries is recalling Medline medical procedure convenience kits labeled as: Breast-hernia-port Cds-lf, Kit, distributed nationwide in the US. The recall was initiated on 12 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1189-2026
- FDA event ID
- 98226
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Dec 2025
- FDA classified
- 28 Jan 2026
- Reported
- 4 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 12 Dec 2025 | Recall initiated by company | |
| 28 Jan 2026 | Classified by FDA | +47 days |
| 4 Feb 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU DYNJT3658A.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
Medline Kit SKU CDS984853L: UDI/DI 10198459293535 (EA) 40198459293536 (CS), Lot Number 25KMI898; Medline Kit SKU DYNJ45641B: UDI/DI 10193489494921 (EA) 40193489494922 (CS), Lot Number 25KMH748; Medline Kit SKU DYNJT3658A: UDI/DI 10198459354007 (EA) 40198459354008 (CS), Lot Number 25KME009.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 98226This product is part of a recall event; the main page for the event is Medline medical procedure convenience kits labeled as recalled.
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