Stryker Recalls IsoFlex LAL Support Surfaces Due to Fire Barrier Defect
Stryker is recalling 243 IsoFlex LAL support surfaces because they were assembled with a non-conforming fire barrier. The units were distributed in five US states.
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 non-conforming fire barrier, which presents a fire hazard. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 243 units of the IsoFlex LAL Support Surface, Model Number 2860. The recall was initiated because certain units were assembled with a non-conforming fire barrier.
The affected products were distributed nationwide in the states of Kentucky, New Hampshire, Ohio, Pennsylvania, and Texas. The specific serial numbers for the recalled units are listed in the official recall documentation.
Healthcare facilities and operators should identify the affected units by checking the serial numbers against the provided list. Stryker is the recalling firm responsible for managing this recall.
The recalled product
- Product
- IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tissue injury) and is recommended to be implemented in…
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Hazard
- Affected units
- 243
Distribution
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