The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1543-2014·Announced 2014-05-14

Med-Mizer RetractaBed Recall Due to Insufficient Welding on Foot Cross Tube

Med-Mizer is recalling 2,980 RetractaBed Clinical Contour adjustable beds due to insufficient welding on the foot cross tube, which may cause bed collapse.

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 structural defect in a medical device that can lead to bed collapse, posing a significant risk of injury to patients, which aligns with the criteria for a Severe rating.

Plain-English summary

Med-Mizer, Inc. is recalling 2,980 units of the RetractaBed Clinical Contour adjustable bed (Models SS 801, 802, 803, and 803A). These beds are AC-powered, 80-inch units designed for acute and long-term care settings, with a maximum safe working load of 450 pounds. The recall covers all configurations of the SS Retractabed Clinical Contour manufactured prior to June 7, 2008.

The recall is due to insufficient welding on the foot cross tube. This component is responsible for holding the two support rails together when using the foot side rails and prevents them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel.

The affected units were distributed nationwide in the United States. Specific serial number ranges are identified for each model: Model 801 (50000-50018), Model 802 (600000-600789), Model 803 (500000-500342), and Model 803A (700000-701724). Users should contact Med-Mizer, Inc. for instructions on how to address the defect.

The recalled product

Product
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
Manufacturer
Med-Mizer, Inc.
Category
Medical Device — Hospital Bed
Hazard
Affected units
2,980

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 (3)

  • Model 801 : 50000-50018
  • Model 802n : 600000-600789 Model 803: 500000-500342
  • 803A 700000-701724

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Med-Mizer, 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 3 products in this recall →

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