IsoFlex LAL Support Surface
Medical device recall Z-3181-2018. Published in FDA’s Enforcement Report on Sep 26, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 26, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 5 states named
- 243 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
243, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 201803286019000540 201803286019000541 201803286019000552 201803286019000553 201803286019000562 201803286019000563 201803286019000564 201803286019000565 201803286019000566 201803286019000572 201803286019000573…
Every code shown here, 1,992 characters
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 201803286019000515 201803286019000516 201803286019000521 201803286019000555 201803286019000567 201803286019000568 201803286019000588 201803286019000589 201803286019000590 201803286019000591 201803286019000001 201803286019000002 201803286019000003 201803286019000004 201803286019000005 201803286019000503 201803286019000504 201803286019000505 201803286019000506 201803286019000507 201803286019000508 201803286019000517 201803286019000518 201803286019000519 201803286019000520 201803286019000522 201803286019000532 201803286019000533 201803286019000534 201803286019000535 201803286019000536 201803286019000537 201803286019000538 201803286019000539 201803286019000557 201803286019000558 201803286019000559 201803286019000560 201803286019000561 201803286019000592 201803286019000593 201803286019000594 201803286019000596 201803286019000597 201803286019000598 201803286019000599 201803286019000604 201803286019000606 201803286019000607 201803286019000608 201803286019000609 201803286019000610 201803286019000611 201803286019000612 201803286019000613 201803286019000614 201803286019000615 201803286019000616 201803286019000617 201803286019000618 201803286019000621 201803286019000622 201803286019000623 201803286019000624 201803286019000625 201803286019000626 201803286019000627 201803286019000628…
FDA’s list runs to 4,632 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide in the states of: KY, NH, OH, PA, and TX.
The states and territories these words name
- Kentucky
- New Hampshire
- Ohio
- Pennsylvania
- Texas
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 13, 2018.
- FDA classified it on Sep 14, 2018.
- FDA’s Enforcement Report published it on Sep 26, 2018.
- FDA terminated it on May 21, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Medical Division of Stryker Corporation, of Portage, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,632 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.