The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0664-2016·Announced 2016-01-27

MWT Materials Recalls Accusorb MRI Arm Sleeves Due to Overheating Risk

MWT Materials, Inc. is recalling 31 Accusorb MRI arm sleeves distributed in New York and Massachusetts because they may overheat and injure patients when not used correctly.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (potential patient injury from overheating) where specific injury counts are not reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

MWT Materials, Inc. is recalling 31 units of Accusorb MRI arm sleeves (Part Number: MRI-02, MAC7002) in various sizes. These products are radio frequency shielding covers used in the MRI environment. The recall covers units distributed nationwide in the states of New York and Massachusetts.

The recall was initiated because the products may overheat when not used correctly, which could lead to patient injury. The source text does not specify the number of reported injuries or illnesses.

Consumers and healthcare facilities should stop using the affected arm sleeves immediately. MWT Materials, Inc. is the recalling firm responsible for the recall.

The recalled product

Product
Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Manufacturer
MWT Materials, Inc.
Category
Medical Device — MRI Accessories
Hazard
Affected units
31

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)

  • All

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 11 recalled by MWT Materials, Inc. 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 11 products in this recall →

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