IsoFlex LAL Support Surface — Class II medical device recall Z-3181-2018
Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2018-09-26, distributed nationwide. Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.
| Recall number | Z-3181-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Medical Division of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2018-08-13 |
| Classified | 2018-09-14 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2020-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 243 |
| Serial numbers | 201801286019000030, 201801286019000034, 201801286019000106, 201801286019000109, 201801286019000110, 201801286019000131, 201801286019000132, 201801286019000133, 201801286019000220, 201802286019000161, 201802286019000162, 201802286019000163, 201802286019000164, 201802286019000165, 201802286019000177, 201802286019000191, 201802286019000192, 201802286019000222, 201802286019000251, 201802286019000252, 201802286019000274, 201802286019000315, 201802286019000351, 201802286019000364, 201802286019000376 and 218 more |
| Model numbers | 2860 |
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 include critical care, step down, progressive care, med/surg, subacute care, and post anesthesia care unit (PACU), or other locations as prescribed by a physician. Operators of this support surface include healthcare professionals (such as nurses, nurse aids, or doctors). IsoFlex LAL support surface is not intended to: be used in a home health environment setting be used as a sterile product include a measuring function be used with a patient less than two years of age Stryker promotes the clinical assessment of each patient and appropriate usage by the operator.
Reason for recall
Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3181-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.