Breast biopsy and dermatology packs recalled over cracking adhesive tubing
Medline is recalling 1,928 total of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a supplier component recall over cracking tubing with no stated consequence or reported harm.
Plain-English summary
Medline medical procedure convenience kits are being recalled by Medline Industries, LP, covering the Breast-Hernia-Port CDS-LF under Medline kit SKU CDS984853L, the Breast Biopsy Pack under SKU DYNJ45641B and the Dermatology Pack under SKU DYNJT3658A.
The record states the 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.
The record lists 1,928 total, with kit SKUs, UDI/DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The record describes a component recalled at the supplier and states no further consequence or reported injuries. Facilities should quarantine affected kits and follow Medline's instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 1,928
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- ModerateMedline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
Same hazard · supplier recall
See all →- ModerateMedline EBSI dressing change kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline breast hernia port kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline femoral block trays contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateCenturion dialysis and dressing change kits contain recalled Mastisol adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline EBSI kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
Similar recalls
- ModerateMedline breast hernia port kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModeratePacemaker and venous access packs recalled over cracking adhesive tubing
FDA (Devices) · 2026-02-04
- ModerateMedline plastic surgery kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline abdominal and bariatric packs contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateAirway and neuro procedure kits recalled over cracking adhesive tubing
FDA (Food) · 2026-02-04
- ModerateMedline vascular and cardiac packs contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24