ModerateClass IITerminated

FDA Devices recall · Reported September 26, 2018

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. Th

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3181-2018.

Q: Where was the recalled product distributed?

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

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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

Recall #: Z-3181-2018
Affected scope: 243
Initiated: August 13, 2018

Compiled from official public sources by the publisher. · Updated September 2026

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Stryker Medical Division of Stryker Corporation recalled IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL su… - a moderate-severity action.

IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL su… was recalled by Stryker Medical Division of Stryker Corporation in September 26, 2018. Reason: Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.. Check the official notice for the remedy. Verify recall #Z-3181-2018 with the FDA Devices before acting.

The recall

Stryker Medical Division of Stryker Corporation issued this moderate-severity FDA Devices recall-Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier..

Moderate
severity level: 243 units
affected scope: Class II
classification: September 26, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-3181-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-3181-2018
Date reported	September 26, 2018
Date initiated	August 13, 2018
Recalling firm	Stryker Medical Division of Stryker Corporation
Firm location	Portage, MI
Affected scope	243
Distribution	US Nationwide in the states of: KY, NH, OH, PA, and TX.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

243 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-3181-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3181-2018.

Where was the recalled product distributed? ▼

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

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported September 26, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026