The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2400-2016·Announced 2016-08-17

Invacare Bariatric Bed Recalled for Potential Fire Hazard from Junction Box Sparks

Invacare is recalling 2,702 Bariatric Beds because the junction box may spark, posing a fire risk in the presence of flammable materials.

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 involves a potential fire hazard, which is a significant injury risk. Per the rubric, significant injury reports or risks (such as fire) in medical devices typically warrant a Severe (4) rating, especially given the FDA Class II classification.

Plain-English summary

Invacare Corporation is recalling 2,702 units of the Invacare Bariatric Bed, including the mattress, rails, and junction boxes. The recall was initiated after the firm identified a quality issue with the junction box used in the bed.

The identified defect is that the junction box may omit sparks, which could result in a fire if flammable materials are present. The affected beds are intended to provide a rest surface with adjustable height and surface contours for home care use.

The recall covers units distributed nationwide in the United States, including the District of Columbia and Puerto Rico, as well as in Canada. Consumers should check their serial numbers against the list provided by the FDA to determine if their unit is affected.

The recalled product

Product
Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
Manufacturer
Invacare Corporation
Category
Medical Device — Hospital Bed
Hazard
Affected units
2,702

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)

  • Model #: BARPKGIVC-1633

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 4 recalled by Invacare Corporation 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 4 products in this recall →

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