FDA Device recall Z-3181-2018
IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of…
- FDA Device
- Class II
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of… by Stryker Medical Division, citing certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3181-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-13 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Medical Division |
| Distribution | US |
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
Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.
Identifiers
| code_info | Serial Numbers: 201803286019000540 201803286019000541 201803286019000552 201803286019000553…Serial Numbers: 201803286019000540 201803286019000541 201803286019000552 201803286019000553 201803286019000562 201803286019000563 201803286019000564 201803286019000565 201803286019000566 201803286019000572 201803286019000573 201803286019000574 201803286019000575 201803286019000576 201803286019000577 201803286019000578 201803286019000579 201803286019000580 201803286019000581 201803286019000585 201803286019000595 201803286019000600 201803286019000602 201803286019000603 201803286019000605 201803286019000619 201803286019000620 201803286019000662 201803286019000663 201803286019000664 201803286019000667 201803286019000668 201803286019000669 201803286019000670 201803286019000710 201803286019000512 20180328601 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3181-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.