The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0663-2016·Announced 2016-01-27

MWT Materials Recalls Accusorb MRI Blankets Due to Overheating Risk

MWT Materials, Inc. is recalling 49 Accusorb MRI blankets because they may overheat and lead to patient injury 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of patient injury (burns/overheating), which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.

Plain-English summary

MWT Materials, Inc. is recalling 49 units of Accusorb MRI blankets (MAC7001, Part Number: MRI-01). These products are radio frequency shielding blankets and body-part covers used in the MRI environment. The recall covers various sizes of the large blanket.

The recall is being issued because the products may overheat when not used correctly, which can lead to patient injury. The agency has classified this as a Class II recall.

The affected units were distributed nationwide in the United States, specifically in the states of New York and Massachusetts. No specific lot numbers or dates are provided in the source text. Users should stop using the affected products and contact the recalling firm for instructions.

The recalled product

Product
Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket 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
49

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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