Invacare Aquatec Ocean Mobile Shower and Toilet Commode Recall
Invacare is recalling Aquatec Ocean mobile shower and toilet commodes because backrest cushion fixtures may unlatch in reclined or tilted positions.
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 (medical device) where the defect could lead to injury, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Invacare Corporation is recalling the Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, and Aquatec Ocean E-VIP mobile shower and toilet commodes with tilting function. The recall involves 538 units in the United States and 3,317 units worldwide, distributed in the US (including Pennsylvania) and Canada.
The recall is due to a defect in the snap-on fixtures of the backrest cushion. These fixtures do not withstand the required pull-out force of 500 N when the product is used in a reclined or tilted position. This defect may result in the snap-on fixture coming unlatched.
Consumers should check their model and serial numbers against the list provided in the official recall notice. If the device is affected, they should contact Invacare Corporation for instructions on how to resolve the issue.
The recalled product
- Product
- Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting function
- Manufacturer
- Invacare Corporation
- Category
- Medical Device — Mobility Aids
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 (20)
- 14541800
- 14541803
- 14541804
- 14541805
- 14541806
- 14541807
- 14541808
- 14541809
- 14541810
- 14541812
- 14541820
- 14541821
- 14541822
- 14541823
- 14541825
- 14541836
- 14541837
- 14541838
- 14541839
- 14541841
Distribution
Distributed in 1 state:
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