Laparoscopy procedure packs recalled over cracking MASTISOL adhesive tubing inside
Medline is recalling 456 units 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 SMJ Lap Chole Pack-LF under Medline kit SKU DYNJ19974P, the DePaul Abdominal Endoscopy-LF under SKU DYNJ20027K, the Laparoscopy Pack-LF under SKU DYNJ20468J and the SMJ Laparoscopy Pack under SKU DYNJ25763, among the kits listed in the enforcement record.
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 456 units, 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) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K; 3) LAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J; 4) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N; 5) SMJ LAPAROSCOPY PACK…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 456
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 (20)
- Medline Kit SKU DYNJ19974P: UDI/DI 10198459138195 (EA) 40198459138196 (CS)
- Lot Number 25KMB830
- Lot Number 25KMB831
- Medline Kit SKU DYNJ20027K: UDI/DI 10198459228957 (EA) 40198459228958 (CS)
- Lot Number 25KMG395
- Lot Number 25KMH132
- Medline Kit SKU DYNJ20468J: UDI/DI 10195327024338 (EA) 40195327024339 (CS)
- Lot Number 25KMF540
- Medline Kit SKU DYNJ25763N: UDI/DI 10198459138218 (EA) 40198459138219 (CS)
- Lot Number 25KMH134
- Medline Kit SKU DYNJ25763O: UDI/DI 10198459603655 (EA) 40198459603656 (CS)
- Lot Number 25KMI209
- Medline Kit SKU DYNJ32836B: UDI/DI 10195327037369 (EA) 40195327037360 (CS)
- Lot Number 25KBF167
- Medline Kit SKU DYNJ43272K: UDI/DI 10198459257131 (EA) 40198459257132 (CS)
- Lot Number 25KME892
- Medline Kit SKU DYNJ43976C: UDI/DI 10193489806694 (EA) 40193489806695 (CS)
- Lot Number 25KMG962
- Medline Kit SKU DYNJ46939Q: UDI/DI 10198459404047 (EA) 40198459404048 (CS)
- Lot Number 25JDA437
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.
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