Agency classClass IIOur severity:Moderate FDA (Food)·H-0428-2026·Announced 2026-02-04

Airway and neuro procedure kits recalled over cracking adhesive tubing

Medline is recalling 857 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 (Food): 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 Drawer 1 Airway under Medline kit SKU ACC010270A, Drawer 2 under SKU ACC010690, Drawer 3 Syr/Drs/Mon/NG 1 of 3 under SKU ACC011073, the Hypospadius Pack under SKU DYNJ00282Q and the SJ Neuro Pack, 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 857 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: Black Bean Bonanza Tamales with Black Beans NO DAIRY Ingredients: Organic Corn Flour Masa, Black Beans, Salsa (Tomatoes, Onions, Chiles, Garlic & Cilantro), Non-GMO Corn, Non-hydrogenated Vegetable Shortening, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium…
Manufacturer: Prima Vera Nueva, Inc.
Category: Medical Device — Procedure kit
Hazard: supplier-recall
cracked-tubing
liquid-adhesive

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 (1)

UPC: 748732000287

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 10 recalled by Prima Vera Nueva, Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Same manufacturer · Prima Vera Nueva, Inc.

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