Stryker InTouch Critical Care Bed Recall Due to Caster Failure
Stryker is recalling InTouch Critical Care Beds because casters may break and fall off, potentially affecting brake functions.
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 medical device where a mechanical failure (caster breakage) can affect brake functions, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 11,632 units of the InTouch Critical Care Bed, including models 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156. The recall was initiated after field complaints indicated that the beds were hoisted or lifted from the floor, causing the casters to fall off.
Investigations revealed that in these instances, the casters broke at the top of the caster stem where the brake rod inserts. If more than one caster on a unit is damaged, the brake functions can be affected. The affected units were distributed worldwide, including across the United States and various international markets.
Healthcare facilities and users should identify affected units by checking the model numbers and serial codes listed in the official recall notice. Stryker is the recalling firm responsible for addressing this safety issue.
The recalled product
- Product
- InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Hospital Bed
- Affected units
- 11,632
Distribution
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