# FDA recall Z-3181-2018

> **Stryker Medical Division of Stryker Corporation** · Class II · device recall initiated 2018-08-13.

## 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 combination with clinical evaluation of risk factors and skin assessments made by a health care professional. This support surface is for use with human patients with existing or at risk of incurring pressure injuries. The patient must not exceed the safe working load as specified by the support surface. A healthcare professional should determine the use of this support surface by patients outside of the therapeutic weight range. The minimum patient age requirement for this support surface is two years. IsoFlex LAL shall be used with a support surface cover at all times. The support surface cover can interact with all external skin. This support surface is for use by patients in an acute care setting. This may i

## Reason for recall

Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.

## Distribution

US Nationwide in the states of:  KY, NH, OH, PA, and TX.

## Key facts

- **Recall number:** Z-3181-2018
- **Recalling firm:** Stryker Medical Division of Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-13
- **Report date:** 2018-09-26
- **Termination date:** 2020-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3181-2018

## Citation

> AI Analytics. FDA recall Z-3181-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-3181-2018. Source: US FDA. Licensed CC0.

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